Device for the delivery of multi-component sealants

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] This disclosure generally relates to the 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

Problems to be Solved by the Invention

[0002]

[0002] During a lung biopsy procedure, a potential concern for medical professionals is to prevent or reduce the possibility of air and / or fluid entering the pleural cavity within the lung. Such a condition is known as pneumothorax and can occur as a result of a puncture hole created during or after a lung biopsy procedure. Pneumothorax is a common event and can result in a prolonged hospital stay. In addition, the subject may require a chest tube in response to the development of pneumothorax. Due to various complications caused by pneumothorax, it may be difficult for medical personnel to seal the puncture hole after the procedure.

[0003]

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

Means for Solving the Problems

[0004]

[0004] According to embodiments of the present disclosure, a medical sealant applicator device for the delivery of a multi-component sealant is provided, comprising a first body having a base, a first syringe plunger, a second syringe plunger, and a longitudinal channel laterally inserted between the first syringe plunger and the second syringe plunger. Each of the first syringe plunger and the second syringe plunger 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 of the medical sealant application device comprises a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber laterally inserted between the first syringe chamber and the second syringe chamber. A longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is connected to the first syringe chamber and the second syringe chamber, respectively, to provide fluid communication. 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 the first proximal plunger piston of the first syringe plunger of the first body. The second syringe chamber of the second body has a second distal opening for slidably receiving the second proximal plunger piston of the 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 translating 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 the delivery of a multi-component sealant is provided, comprising 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 laterally inserted 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 laterally inserted between the first and second syringe chambers. A longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is connected to fluid communication with the first syringe chamber and the second syringe chamber, respectively. 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 the first proximal plunger piston of the first syringe plunger of the first body. The second syringe chamber of the second body has 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 translating in 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. The guide assembly sets a path toward the target position and maintains that path while the needle assembly advances and the component is injected.

[0006]

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

[0007]

[0007] In another embodiment, the component delivery system includes a needle assembly, an applicator, a first body, and a second body. The needle assembly has an elongated needle having a proximal end and a distal end spaced apart from each other and defining at least one fluid path between them. The distal end has one or more fluid outlets connected to at least one fluid path. The applicator is fluid-coupled to the proximal end of the needle assembly. The applicator includes a first body comprising a first biasing assembly coupled to the needle assembly. The first body biases the needle assembly proximal to the applicator. The second body includes a syringe chamber having a needle connector port at the proximal end fluid-coupled to the needle assembly, and a syringe plunger disposed within the syringe chamber and movable within the syringe chamber at the distal end. A second biasing assembly is connected between the first body and the second body, and the second biasing assembly biases the syringe plunger at the distal end of the syringe chamber.

[0008]

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

[0009] [Figure 1]

[0009] This is a perspective view showing a component delivery system including a protective spacer according to one or more embodiments shown and described herein. [Figure 2]

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

[0011] Figure 3A is a detail diagram showing a component delivery system along section 3A of Figure 2, according to one or more embodiments shown and described herein. [Figure 3B]

[0012] Figure 3B is a detail diagram showing a component delivery system with selected components excluded, according to one or more embodiments shown and described herein. [Figure 4]

[0013] This is a perspective view showing a guide assembly according to one or more embodiments shown and described herein. [Figure 5]

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

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

[0016] This is a perspective view showing the guide assembly of Figure 4 with selected components removed, according to one or more embodiments shown and described herein. [Figure 8]

[0017] Another perspective view showing the guide assembly of Figure 4 with selected components removed, according to one or more embodiments shown and described herein. [Figure 9]

[0018] Another perspective view showing the guide assembly of Figure 4 with selected components removed, according to one or more embodiments shown and described herein. [Figure 10]

[0019] This is a detail diagram showing a guide assembly along section 10 of Figure 4, according to one or more embodiments shown and described herein. [Figure 11]

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

[0021] This is a perspective view showing a component delivery system and guide assembly in a second position according to one or more embodiments shown and described herein. [Modes for carrying out the invention]

[0010]

[0022] Next, we will refer in detail to various embodiments of component delivery systems for administering sealant to a patient, the embodiments of which are shown in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout multiple drawings to refer to the same or similar parts. For example, the directional terms used herein, such as upward, downward, right, left, forward, backward, apex, base, distal, and proximal, are made based solely on the figures depicted and are not intended to implicitly imply absolute orientation.

[0011]

[0023] In this specification, a range may be expressed as from one "approximate" specific value to and / or to another "approximate" specific value. Where such a range is expressed, another embodiment includes this one specific value to and / or to another specific value. Similarly, where a value is expressed as an approximate value by using the preceding term "approximately", it will be understood that this specific value forms another embodiment. Furthermore, it will be understood that each endpoint of a range is significant both in relation to the other endpoint and independently of the other endpoint.

[0012]

[0024] Unless otherwise specified, no method described in this specification is intended to be construed as requiring that its steps be performed in a particular order, nor is any particular orientation of any device intended. Thus, if a method claim does not actually recite an order for the steps to follow, or if any apparatus claim does not actually recite an order or orientation for individual components, the steps are not limited to a particular order only as specifically recited elsewhere in the claims or this description, or if no specific order or orientation for the components of the device is recited, no order or orientation is intended to be inferred in any way. This applies to any possible unstated interpretive criteria, including: logical matters related to the composition of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical construction or punctuation; and the number or type of embodiments described in this specification.

[0013]

[0025] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The terminology used in the description of this specification is for the purpose of describing particular embodiments only 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 as well, unless the context clearly dictates otherwise.

[0014]

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

[0015]

[0027] During a lung biopsy procedure, a potential concern for a medical professional is that air and / or fluid may enter into the pleural cavity within the lung. To mitigate this, the present disclosure is directed to a component delivery system that seals the path created by a needle assembly while the needle assembly penetrates into a patient. When 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 such that the multi-component sealant has an appropriate ratio. The component delivery system may be disposed within a guide assembly. The guide assembly is disposed over a subject. The guide assembly enables a medical professional to control the height and the angle of the component delivery system.

[0016]

[0028] The component delivery system has a technical effect in which, in response to a medical professional applying the component delivery system, the first body of the component delivery system is pushed toward the second body of the component delivery system. The second body contains each component of the multi-component sealant. After the second body is pushed toward the first body, each component is distributed from the first body to the mixing chamber. Within the mixing chamber, the multi-component sealant begins to mix and is distributed from the 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 penetrates the patient. Depth control of the guide assembly moves the needle assembly along a single direction. Angle control changes the insertion angle of the needle assembly. Adjusting the angle of the needle assembly does not affect the depth of the guide assembly. I. Component Delivery System

[0030] Next, referring to Figures 1-3B, several embodiments of the component delivery system 100 are shown. The component delivery system 100 may be used during medical procedures and / or medical research. The component delivery system 100 includes an applicator 101, a mixing chamber 120, and a needle assembly 122 fluid-coupled to the applicator 101.

[0018]

[0031] Applicator 101 stores each component of a multi-component sealant. In response to a biasing force, applicator 101 delivers each component of the multi-component sealant to the mixing chamber 120. Applicator 101 includes a first body (in other words, a main body) 103 and a second body 102. The first body 103 is located at the first axial end of applicator 101 and is positioned around the central axis 105 of the component delivery system 100. The second body 102 is located at the second axial end of applicator 101 and is similarly positioned around the central axis 105. As discussed herein, the first body 103 cooperates with the second body 102 to deliver each component of the multi-component sealant to the mixing chamber 120 in response to a biasing force. Specifically, the biasing force causes each component of the multi-component sealant to flow from applicator 101 to needle assembly 122 while maintaining a controlled flow rate.

[0019]

[0032] Referring next to Figure 3B, the first body 103 includes a base 103a, a first syringe plunger 103b, a second syringe plunger 103c, a first finger-holding projection 117a, and a second finger-holding projection 117b. As depicted, the base 103a defines an elliptical shape, but other geometric shapes are also intended and possible (e.g., rectangle, triangle, hexagon). The base 103a defines a distal aperture extending through the depth of the base 103a, centrally located 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 further positioned on both sides of the first surface of the base 103a. Each of the first syringe plunger 103b and the second syringe plunger 103c can be connected to the base 103a (e.g., by bonding, fixing, plastic welding) or integrated with the base 103a (e.g., by machining, molding, forming, 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 tip 103d, and the second syringe plunger 103c includes a second plunger tip 103e. Each plunger tip 103d, 103e may be constructed of rubber, plastic, or any suitable material. The first syringe plunger 103b contacts the first component of the multi-component sealant via the first plunger tip 103d, and the second syringe plunger 103c contacts the second component of the multi-component sealant via the second plunger tip 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 force to the respective components of the multi-component sealant. As depicted, the first syringe plunger 103b and the second syringe plunger 103c are piston-type rods defining the apex of a cone shape. However, any suitable syringe plunger may be used.

[0022]

[0035] The first finger-holding projection 117a and the second finger-holding projection 117b extend laterally from the first body 103 in a direction perpendicular to the central axis 105. The first finger-holding projection 117a and the second finger-holding projection 117b each define a curved profile (in other words, a contour). The curved profile is shaped to provide the medical professional with an ergonomic feel, as a result allowing the medical professional's first finger to apply force to or hold the first finger-holding projection 117a, and the medical professional's second finger to apply force to or hold the second finger-holding projection 117b. Although depicted as a curved profile, other geometric shapes are also conceived and possible. For example, the finger-holding projections 117a and 117b could be enclosed circles.

[0023]

[0036] A force may be applied proximal to the second body 102 along the central axis 105. In embodiments, the first finger-retaining projection 117a and the second finger-retaining projection 117b may be used to firmly hold (for example, stabilize) the base 103a when applying the applicator 101. In embodiments, three or more finger-retaining projections may be used.

[0024]

[0037] The second body 102 is positioned at the axial end of the applicator 101, opposite the first body 103. The second body 102 is positioned around the central axis 105 and can 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 engagement element 116 is positioned at the second axial end of the applicator 101 and is positioned around the central axis 105. As depicted, the engagement element 116 defines a flat profile, but other geometric profiles are also intended and possible (e.g., concave profile, convex profile). The engagement element 116 is shaped to provide an ergonomic profile, as a result allowing a medical professional's fingers to easily apply force to the engagement element 116 with the aim of applying force to the second body 102 toward the first body 103 along the central axis 105. Because the engagement element 116 is positioned around the central axis 105 and thereby concentric with the second body 102, the force applied to the engagement element 116 is evenly distributed with respect to the second body 102. The engagement element 116 may define multiple protrusions to assist a medical professional in engaging with the engagement element 116.

[0027]

[0040] A force is applied to the applicator 101 in order to apply the multi-component delivery system 100. In one embodiment, a force is applied to the engaging element 116, thereby causing the second body 102 to move toward the first body 103. In another embodiment, a force is applied to the first finger-holding projection 117a and the second finger-holding projection 117b, thereby causing the first body 103 to move toward the second body 102.

[0028]

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

[0029]

[0042] The first syringe plunger 103b extends into the first syringe percha 104a of the first syringe barrel 104. The first syringe plunger 103b and the first syringe percha 104a are sized collaboratively such that the 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 from being exposed to the atmosphere. The inner diameter of the first syringe barrel 104 can be adjusted to control the rate (in other words, flow rate) of the component exiting the first syringe barrel 104 during application. For example, if the ratio required to produce a multi-component seal requires an additional amount of the first component, the inner diameter of the first syringe barrel 104 may be enlarged. In addition, if the ratio required to produce 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 a force applied to the applicator 101, a biasing force is applied to the first component in the first syringe barrel 104 via the first syringe plunger 103b. In other words, in response to the engaging element 116 being pushed toward the first body 103 and / or the finger-holding projections 117a, 117b being pushed toward the second body 102, the first syringe plunger 103b is translated toward the second body 102 within the first syringe barrel 104. The first syringe plunger 103b is then able to 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 connected to and fluidized by the first U-shaped connector 106. The first U-shaped connector 106 extends laterally from the first syringe barrel 104 toward the central axis 105 (for example, perpendicular to the central axis 105). In the embodiment, the first U-shaped connector 106 is integrated with 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 fluidized 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 (for example, within the first syringe barrel 104) to movement toward the first body 103 (for example, after exiting the first U-shaped connector 106). The first U-shaped connector 106, with its curved shape, prevents the formation of a bottleneck (in other words, a constriction) in the fluid path. This allows the fluid to exit the applicator 101 at a constant flow rate. As the first component continues to move, it can exit the first U-shaped connector 106.

[0032]

[0045] A first U-shaped connector 106 can be connected to a first longitudinal barrel 108 for fluid coupling. In embodiments, the first U-shaped connector 106 is integrated with the first longitudinal barrel 108. The first longitudinal barrel 108 can 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 guided toward the first body 103. The first longitudinal barrel 108 can 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 it 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 percha 110a of the second syringe barrel 110. The second syringe plunger 103c and the second syringe percha 110a are sized collaboratively 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 from being exposed to the atmosphere. The inner diameter of the second syringe barrel 110 can be adjusted to control the rate at which the component exits the second syringe barrel 110 during application. For example, if the ratio required to create a multi-component seal requires an additional amount of the second component, the inner diameter of the second syringe barrel 110 may be enlarged. In addition, if a smaller proportion of the second component is required to produce a multi-component seal, the inner diameter of the second syringe barrel 110 may be reduced.

[0035]

[0048] In response to a force applied to the applicator 101, a biasing force is applied to the second component in the second syringe barrel 110 via the second syringe plunger 103c. In other words, in response to the engaging element 116 being pushed toward the first body 103 and / or the finger-holding projections 117a, 117b being pushed toward the second body 102, the second syringe plunger 103c is translated toward the second body 102 within the second syringe barrel 110. The second syringe plunger 103c is then able to 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 connected to and fluidized by the second U-shaped connector 112. The second U-shaped connector 112 extends laterally from the second syringe barrel 110 toward the central axis 105 (for example, perpendicular to the central axis 105). In the embodiment, the second U-shaped connector 112 is integrated with 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 fluidized to the second U-shaped connector 112. By defining a U-shaped fluid path, the second component is redirected from movement toward the second body 102 (for example, within the second syringe barrel 110) to movement toward the first body 103 (for example, after exiting the second U-shaped connector 112). The second U-shaped connector 112, with its curved shape, prevents the formation of a bottleneck in the fluid path. This allows the fluid to exit the applicator 101 at a constant flow rate. As the second component continues to move, it can exit the second U-shaped connector 112.

[0037]

[0050] A second U-shaped connector 112 can be connected to a second longitudinal barrel 114 for fluid coupling. In embodiments, the second U-shaped connector 112 is integrated with the second longitudinal barrel 114. The second longitudinal barrel 114 can 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 guided toward the first body 103. The second longitudinal barrel 114 can be constructed of plastic, glass, or any other suitable material.

[0038]

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

[0039]

[0052] As depicted, the side walls for the mixing chamber 120 define a profile that tapers inward, resulting in the mixing inlet 120a having a larger area than the mixing outlet 120b. This allows the first and second components, received by the first longitudinal barrel 108 and the second longitudinal barrel 114, to begin interfacial contact with each other, minimizing the chance of bottlenecks occurring within the mixing chamber 120. However, other shapes are also conceived and possible. For example, in embodiments, the area of ​​the mixing outlet 120b may be larger than or equal to the area of ​​the mixing inlet 120a. In these embodiments, the side walls of the mixing chamber 120 can define a profile that tapers outward or can 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 connected to the mixing inlet 120a of the 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 and second components are supplied to the mixing inlet 120a of the mixing chamber 120. Thus, within the mixing chamber 120, the first and second components can come into interfacial contact and begin to mix.

[0041]

[0054] In one embodiment, the first and second components do not mix in the mixing chamber 120. In another embodiment, the first and second components begin to mix in the mixing chamber 120 and begin to form a multi-component sealant. In yet another embodiment, the first and second components are completely mixed in the mixing chamber 120, thereby forming a multi-component sealant.

[0042]

[0055] In these 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, and as a result, the first and second components are in interfacial contact within the combined first and second longitudinal barrels 108 and 114. Continuing in these embodiments, the first longitudinal barrel 108 and / or the second longitudinal barrel 114 define a helical profile (not shown) for interfacial contact between the first component and the second component.

[0043]

[0056] Referring next to Figure 1, the component delivery system 100 is shown with a removable stopper 118. To prevent unintended application of the applicator 101, a medical professional may assemble the removable stopper 118 onto the component delivery system 100. The removable stopper 118 is assembled onto the applicator 101 between the first body 103 and the second body 102, thereby preventing the second body 102 from moving toward the first body 103. The removable stopper 118 may be positioned on the applicator 101 until the component delivery system 100 is ready for use by a medical professional. In embodiments, the removable stopper 118 is integrated with the component delivery system 100 (e.g., molded, cast) and includes a removable tab to allow for easy disassembly of the removable stopper 118 from the component delivery system 100. The removable stopper 118 may be constructed of plastic, ceramic, metal, or any suitable material.

[0044]

[0057] The removable stopper 118 may include a first stopper element 118a and a second stopper element 118b. When the removable stopper 118 is assembled to the applicator 101, the first stopper element 118a is positioned on the first syringe plunger 103b and between the base 103a and the first syringe barrel 104. In addition, the second stopper element 118b is positioned on the second syringe plunger 103c and between the base 103a and the second syringe barrel 110. In the embodiment, each stopper element 118a, 118b may be detachably connected to each syringe barrel 104, 110 via a snap-fit ​​connection or an optional suitable similar connection. In this way, the removable stopper 118 prevents the second body 102 from moving toward the first body 103 due to physical interference by the first stopper element 118a and the second stopper element 118b. The removable stopper 118 can then be removed when the component delivery system 100 is intended to be used. In some embodiments, the removable stopper 118 may include only one of the first stopper element 118a or the second stopper element 118b.

[0045]

[0058] Referring to Figure 2, a needle assembly 122 is shown, which includes a connector hub 122a and an elongated needle 122b. The needle assembly 122 is centrally located along the central axis 105 and extends along the central axis 105. The needle assembly 122 distributes the multi-component sealant from the applicator 101 to the target location in the patient. The needle assembly 122 is located at the axial end of the component delivery system 100, opposite the opposite axial end of the component delivery system 100 (for example, where the engaging element 116 is located). The needle assembly 122 can be any available needle assembly used in medical applications. The needle assembly 122 begins distributing the multi-component sealant as it enters the target location in the patient.

[0046]

[0059] The connector hub 122a is connected to the mixing outlet 120b and fluid-coupled. The connector hub 122a is positioned around the central axis 105. As depicted, the connector hub 122a is embedded in the mixing outlet 120b. However, other fixing methods, such as fixing screws or adhesive, may also be used to connect the connector hub 122a to the mixing outlet 120b. In embodiments, the connector hub 122a is integrated into the mixing chamber 120 (e.g., by casting, forming, machining, or molding). As the first component, second component, and / or multi-component sealant continue to move, the first component, second component, and / or multi-component sealant exit the mixing outlet 120b and enter the connector hub 122a. In embodiments, the first component and second component may begin to mix or continue to mix within the connector hub 122a.

[0047]

[0060] An elongated needle 122b is connected to and fluidly coupled to a connector hub 122a. The elongated needle 122b is positioned around a central axis 105 and extends along the central axis 105. In embodiments, the connector hub 122a may be integrated with the connector hub 122a. In embodiments, the elongated needle 122b receives a fully mixed multi-component sealant from the connector hub 122a. In embodiments, the first and second components may begin to mix within the elongated needle 122b or may continue to mix.

[0048]

[0061] An elongated needle 122b defines a needle exit 122c. The needle exit 122c is located at the axial end of the elongated needle 122b opposite the connector hub 122a. The multi-component sealant is distributed from the elongated needle 122b through the needle exit 122c to the target location in the patient.

[0049]

[0062] The component delivery system 100 delivers a multi-component sealant to the patient while the needle assembly of the component delivery system 100 is inserted into the pleural cavity of the patient's lung. This allows the medical professional to seal the pathway of the needle assembly during needle insertion. As the needle assembly 122 is inserted into the pleural cavity of the patient's lung, each component of the multi-component sealant is released from its respective syringe barrel in response to the force applied to the component delivery system 100. 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] Thus, a multi-component sealant can be used due to the configuration of the component delivery system 100, which achieves a controlled ratio of each component. This is advantageous because multi-component sealants may be superior to single-component sealants in terms of sealing. In addition, the rate of component delivery system 100 can be distributed in a controllable manner. This is advantageous because it reduces the possibility of medical professionals applying too much or too little sealant to the patient. II. Guide System

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

[0051]

[0065] The component delivery system 100 is positioned within the guide assembly 420. The guide assembly 420 is positioned around the guide axis 401a. When a medical professional is ready to distribute the multi-component sealant to a patient during a medical procedure and / or medical study, the guide assembly 420 is positioned over the patient's skin, allowing the needle assembly 122 to enter the skin and move parallel toward the target treatment area.

[0052]

[0066] The guide assembly 420 enables medical professionals to control the placement of the component delivery system 100 before injecting the multi-component sealant. Medical professionals can use the guide assembly 420 to control the depth of the component delivery system 100, thereby enabling them to determine the desired depth adjustment amount of the needle assembly 122 before insertion into the patient. The component delivery system 100 defines a central axis 105. The guide assembly 420 allows for depth adjustment along the central axis 105 of the component delivery system 100.

[0053]

[0067] Medical professionals can further use the guide assembly 420 to determine the angle of the component delivery system 100, thereby enabling them to control the insertion angle 401c of the needle assembly 122 before insertion into the patient. The insertion angle 401c can be defined by comparing the deviation of the central axis 105 from the guide axis 401a. As shown in Figure 4, the insertion angle 401c of the component delivery system 100 is depicted as being in the first position of the system 400. As shown in Figure 5, the guide assembly 420 is in the second position after being adjusted to achieve a different insertion angle 401c.

[0054]

[0068] Continuing to refer to Figures 11-12, the base 103a defines the base surface 103f. As will be 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 exit 422c, and a second shaft surface 422d (shown in Figures 5-6). The component delivery system 100 is removably connected to the guide assembly 420 by bringing the base 103a into contact with the first shaft surface 422a of the threaded shaft 422. The base surface 103f can define a flat profile, but other shapes are also intended and possible. For example, the base surface 103f may have a protruding profile, and the first shaft surface 422a may be shaped and sized to define a receiving cavity for receiving the protruding profile.

[0055]

[0069] In the embodiment, the base surface 103f includes engaging elements (e.g., snap-fit ​​connectors, fasteners) for removably securing the component delivery system 100 to the guide assembly 420. This ensures that 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 allows for better control by the medical professional using the system 400 before injecting the multi-component sealant into the patient during the procedure.

[0056]

[0070] When the component delivery system 100 is positioned 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 continues to extend out of the shaft exit 422c.

[0057]

[0071] Referring to Figure 4, the depth adjustment component of the guide assembly 420 includes a threaded shaft 422, a collar 424, and a shaft platform (in other words, a base) 426. The angle adjustment component of the guide assembly 420 includes a curved platform 427, a first guide member 428, and a second guide member 430.

[0058]

[0072] A threaded shaft 422 enables depth adjustment of the guide assembly 420. As discussed above, the threaded shaft 422 includes a first shaft surface 422a, a threaded portion 422b, a shaft outlet 422c, and a second shaft surface 422d. The second shaft surface 422d is located on the shaft head of the threaded shaft 422, opposite the first shaft surface 422a. As depicted, the threaded portion 422b defines the outwardly positioned thread. In embodiments, the threaded portion 422b defines the female thread. The threaded shaft 422 may be constructed of metal or plastic, etc. The shaft outlet 422c is sized to allow the use of a variety of needle assembly gauges.

[0059]

[0073] Referring next to Figures 7-9, the collar 424 includes a first collar surface 424a, a female thread 424b, a sleeve 424c, and a second collar surface 424d. The first collar surface 424a is positioned 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 female thread 424b of the collar 424. At this point, the female thread 424b of the collar 424 can lock (in other words, fix) the threaded shaft 422 in place. In addition, the female thread 424b allows for fine adjustment of the threaded shaft 422 by fastening the threaded shaft 422 along the central axis 105.

[0060]

[0074] This allows a medical professional to adjust the depth-direction position 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 female thread 424b of the collar 424 with the threaded portion 422b of the threaded shaft 422 in the locked position. In addition, the medical professional can also make fine adjustments by tightening the threaded shaft 422 along the central axis 105. Regardless of the adjustments made to achieve the desired penetration angle 401c, the depth of the needle assembly 122 relative to the patient's skin is maintained. In embodiments where the threaded portion 422b of the threaded shaft 422 is positioned internally, the threads of the collar 424 may be positioned on the external surface of the collar 424.

[0061]

[0075] The shaft platform 426 includes a shaft surface 426a, an engaging tab 426b, a slot 426c, and an outer shaft surface 426d. The shaft platform 426 is partially positioned within the sleeve 424c of the collar 424 and is connected to the collar 424. In embodiments, the collar 424 is integrated with the shaft platform 426. When the threaded shaft 422 is positioned within the collar 424, the threaded shaft 422 is simultaneously positioned 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 slide along the length of the shaft platform 426 and the collar 424 before engaging with the female thread 424b of the collar 424. This is advantageous because it allows for large depth adjustments without requiring the threaded shaft 422 to be fully tightened or untightened along the central axis 105. As depicted, the outer shaft surface 426d of the shaft platform 426 is circular, but other geometric profiles are also conceived and possible.

[0062]

[0076] The arched platform 427 includes an engagement slot 427a, an arched surface 427b, and an arched rail 427c. The arched platform 427 surrounds the outer edge of the threaded portion 422b of the threaded shaft 422. The engagement slot 427a is formed within the arched surface 427b. The engagement tab 426b of the shaft platform 426 connects the shaft platform 426 to the arched platform 427 via the engagement slot 427a. The arched rail 427c is positioned on both sides of the arched surface 427b and extends at least partially along both sides of the arched surface 427b.

[0063]

[0077] In response to a force applied to the curved rail 427c, the curved platform 427 moves accordingly in the direction of the applied force. Since the curved platform 427 is connected to the shaft platform 426, this force causes the shaft platform 426 and the collar 424 to move in parallel. This causes the component delivery system 100, located within the shaft platform 426 and the collar 424, to move in parallel.

[0064]

[0078] Referring again to Figure 4, the first guide member 428 and the second guide member 430 are shown. The first guide member 428 and the second guide member 430 allow adjustment of the penetration angle 401c of the component delivery system 100. The first guide member 428 and the second guide member 430 cooperate to achieve the penetration angle 401c by each being able to rotate on a pivot axis.

[0065]

[0079] The first end 428a of the first guide member 428 is connected to the first side 432a of the base 432. The second end 428b of the first guide member 428 is connected to the second side 432b of the base 432. The first side 432a and the second side 432b of the base 432 are positioned on opposite sides of the base 432.

[0066]

[0080] The first guide member 428 defines an arc-shaped profile between the first end 428a and the second end 428b. The first intermediate portion 428d of the first guide member 428 is positioned between the first end 428a and the second end 428b. The first intermediate portion 428d contacts the arc-shaped surface 427b of the arc-shaped platform 427. In addition, the first intermediate portion 428d contacts the arc-shaped rail 427c of the arc-shaped platform 427. In response to a force, the first guide member 428 rotates on a first axis of rotation that is perpendicular to the length of the first guide member 428.

[0067]

[0081] To adjust the entry angle 401c of the component delivery system 100, a medical professional can apply force to any component of the component delivery system 100 or the guide assembly 420. When the components of the guide assembly 420 are connected to each other, the applied force is ultimately transmitted to the curved rail 427c of the curved platform 427. The force applied to the curved rail 427c is transmitted to 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 on the first axis of rotation. The first guide member 428 may be constructed of plastic, metal, or any other suitable material.

[0068]

[0082] The first end 430a of the second guide member 430 is connected to the third side 432c of the base 432. The second end 430b of the second guide member 430 is connected to the fourth side 432d of the base 432. The third side 432c and the fourth side 432d of the base 432 are located on opposite sides of the base 432.

[0069]

[0083] The second guide member 430 defines an arc-shaped profile between the first end 430a and the second end 430b. The second intermediate portion 430d of the second guide member 430 is positioned 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. In addition, the first intermediate portion 428d contacts the outer shaft surface 426d of the shaft platform 426. In response to a force, the second guide member 430 rotates on a second axis of rotation that is perpendicular to the length of the second guide member 430.

[0070]

[0084] To adjust the entry angle 401c of the component delivery system 100, a medical professional can apply force to any component of the component delivery system 100 or the guide assembly 420. When the components of the guide assembly 420 are connected to each other, the applied force is ultimately transmitted to the outer shaft surface 426d of the shaft platform 426. The force applied to the outer shaft surface 426d is transmitted to 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 on the second axis of rotation. The second guide member 430 may 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 over the penetration of the needle assembly 122 of the component delivery system 100, with both depth control and angle control.

[0072]

[0086] Referring now to Figure 10, details 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 into the aperture of the third side 432c and connects to the aperture of the third side 432c. The first end 430a connects 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 shaft 434 are further shaped and sized so that they adjust in response to the first guide member 428 being subjected to a rotational force. The second side 432b of the second guide member 430 and the first end 428a and second end 428b of the first guide member 428 are molded and sized in a similar manner to the first side 432a of the second guide member 430. Thus, each of the first end 428a and second end 428b of the first guide member 428 and the first end 430a and second end 430b of the second guide member 430 may include a shaft 434 positioned within its respective base end.

[0074]

[0088] Therefore, 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 positioned around the guide axis 401a and is placed on the patient. The base 432 can be constructed from any suitable material for medical use, such as plastic or metal. As depicted, the base 432 defines a disc-like geometry. However, other geometries are conceivable and possible. For example, the base 432 may also define a curved profile, which would allow the base 432 to be better applied to curved surfaces of the patient (e.g., the patient's arm, the patient's leg). The base 432 defines a central aperture, which would allow the needle assembly 122 of the component delivery system 100 to contact the patient's skin.

[0075]

[0090] This specification discloses a component delivery system having a first body and a second body containing each component of a multi-component sealant. When the engaging element of the component delivery system is applied, the first body is moved toward the second body. This distributes each component from the first body to the mixing chamber. Within the mixing chamber, the multi-component sealant begins to mix and is then distributed from the needle assembly of the component delivery system.

[0076]

[0091] This specification further discloses guide assemblies that may be used with a component delivery system or any other syringe / needle assembly. The guide assembly can control the depth and angle of the component delivery system before insertion into the patient. Depth control of the guide assembly moves the component delivery system along a single direction, while angle control controls the insertion angle of the component delivery system. The guide assembly can adjust 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 embodiments. In a first embodiment, a medical sealant applicator device for the 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 laterally inserted 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 of the medical sealant application device comprises a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber laterally inserted 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 the first proximal plunger piston of the first syringe plunger of the first body. The second syringe chamber of the second body has a second distal opening for slidably receiving the second proximal plunger piston of the 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 translating within the longitudinal channel of the first body in response to the longitudinal translation of the second body relative to the first body.

[0078]

[0093] In a second embodiment considering the first embodiment, when a force is applied distally to the proximal ends of the first syringe barrel and the second syringe barrel, 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, thereby causing the first syringe plunger and the second syringe plunger to move proximal to the first syringe barrel and the second syringe barrel, and the elongated needle to move distally away from its base in the distal direction opposite to the proximal direction.

[0079]

[0094] In a third or second embodiment considering the first embodiment, the base of the first body includes a distal aperture, a longitudinal channel extends from the distal aperture in a first direction, 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 detachably connected to a distal needle connector port of a second body, and the elongated needle extending from the second body through the distal aperture of the base of the first body.

[0080]

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

[0081]

[0096] In a fifth embodiment, which follows any one of the first to fourth embodiments, the medical sealant applicator device includes: a pair of finger-holding projections extending laterally from the base of the first body.

[0082]

[0097] In a sixth embodiment, which follows any one of the first to fifth embodiments, the medical sealant applicator device comprises: a guide assembly for setting the depth of advancement of an elongated needle.

[0083]

[0098] In a seventh embodiment, a medical sealant applicator device for the 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 laterally inserted 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 laterally inserted between the first and second syringe chambers. A longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is connected to the first syringe chamber and the second syringe chamber, respectively, to provide fluid communication. 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 the first proximal plunger piston of the first syringe plunger of the first body. The second syringe chamber of the second body has 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 translating within the longitudinal channel of the first body in response to longitudinal translation of the second body relative to the first body. The guide assembly sets a path toward the target position and maintains that path while the needle assembly advances and the component is injected.

[0084]

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

[0085]

[0100] In a ninth aspect according to the seventh or eighth aspect, the base of a first body includes a distal aperture, a longitudinal channel extends from the distal aperture in a first direction, 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 detachably connected to a distal needle connector port of a second body, and the elongated needle extending from the second body through the distal aperture of the base of the first body.

[0086]

[0101] In a tenth embodiment, which follows any one of the seventh to ninth embodiments, the second body includes a first U-shaped connector that connects the proximal end of a longitudinal fluid chamber to a first syringe chamber for fluid communication, and a second U-shaped connector that connects the proximal end of a longitudinal fluid chamber to a second syringe chamber for fluid communication.

[0087]

[0102] In the eleventh embodiment, which follows any one of the seventh to tenth embodiments, a pair of finger-holding projections extend laterally from the base of the first body.

[0103] In a twelfth embodiment, which follows any one of the seventh to eleventh embodiments, the guide assembly sets the depth of advancement of the elongated needle.

[0088]

[0104] In a thirteenth aspect, the method includes establishing 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 through the pleural cavity at a first velocity to a known distance. The method further includes applying a distal force to the proximal end of the needle assembly, wherein the force simultaneously injects a substance at a second velocity.

[0089]

[0105] In the 14th aspect according to the 13th aspect, the needle assembly is advanced simultaneously with the application of force.

[0106] In the 15th embodiment according to the 13th or 14th embodiment, the first velocity of the needle assembly is correlated with the second velocity of material injection.

[0090]

[0107] In the 16th aspect according to the 15th aspect, the correlation between the first velocity of the needle assembly and the second velocity of injecting the substance can be modified.

[0108] In the 17th embodiment, which follows any one of the 13th to the 16th embodiment, the guide assembly further advances the needle assembly into the patient's lung.

[0091]

[0109] In the 18th embodiment, the component delivery system includes a needle assembly, an applicator, a first body, and a second body. The needle assembly has an elongated needle having a proximal end and a distal end spaced apart from each other and defining at least one fluid path between them. The distal end has one or more fluid outlets connected to at least one fluid path. The applicator is fluid-coupled to the proximal end of the needle assembly. The applicator includes a first body comprising a first biasing assembly coupled to the needle assembly. The first body biases the needle assembly proximal relative to the applicator. The second body includes a syringe chamber having a needle connector port at its proximal end, which is fluid-coupled to the needle assembly, and a syringe plunger disposed within the syringe chamber and movable within the syringe chamber at its distal end. A second biasing assembly is connected between the first body and the second body, and the second biasing assembly biases the syringe plunger at the distal end of the syringe chamber.

[0092]

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

[0093]

[0111] In a 20th embodiment according to the 18th or 19th embodiment, the needle assembly further comprises a connector hub detachably connected to a needle connector port, with an elongated needle extending from a second body through a first body.

[0094]

[0112] In the 21st embodiment, which follows any one of the 18th to 20th embodiments, a pair of finger-holding projections extending laterally from the first body are included.

[0113] A 22nd embodiment, which follows any one of the 18th to 21st embodiments, includes a guide assembly for setting the depth of advancement of an elongated needle.

[0095]

[0114] In a 23rd embodiment according to any one of the 18th to 22nd embodiments, the guide assembly further includes a depth adjustment component, a base, and an angle adjustment component. The depth adjustment component includes a threaded shaft having a shaft head having a first shaft surface and a second shaft surface opposite the first shaft surface, the first shaft surface of which contacts a component delivery system; a collar having a female thread that is screw-engaged to the threaded shaft in a locking setting, and a slot that allows parallel movement of the threaded shaft along the central axis of the guide assembly in an adjustment setting; a shaft platform that contacts the second shaft surface of the shaft head; and a curved platform connected to the shaft platform. The angle adjustment component comprises a first guide member having a first end connected to a base, a second end connected to a base, and a first intermediate portion between the first end and the second end, wherein the first intermediate portion is positioned at a distance from the base and in contact with the arched platform; and a second guide member having a first end connected to a base, a second end connected to a base, and a second intermediate portion between the first end of the second guide member and the second end of the second guide member, wherein the second intermediate portion is positioned at a distance from the base and in contact with the shaft platform.

[0096]

[0115] In a 24th aspect according to the 23rd aspect, the threaded shaft is movable along the central axis while in the adjustment setting.

[0116] In the 25th aspect according to the 23rd aspect, a depth adjustment component is movably connected to a first guide member along a first rotation axis, and a second guide member is movably connected along a second rotation axis that is perpendicular to the first rotation axis.

[0097]

[0117] In a 26th embodiment, which follows any one of the 23rd to 25th embodiments, the threaded shaft further includes a threaded portion defining an outer diameter, and the slot defines an inner diameter that is larger than the outer diameter.

[0098]

[0118] In the 27th embodiment, which follows any one of the 23rd to 26th embodiments, an elongated needle is disposed inside the shaft outlet of a threaded shaft.

[0119] In the 28th embodiment, which follows any one of the 23rd to 26th embodiments, the first end and the second end are rotatably connected to the base, thereby facilitating the rotation of the first guide member relative to the base.

[0099]

[0120] In the 29th embodiment, which follows any one of the 23rd to 28th embodiments, the first end of the second guide member and the second end of the second guide member are rotatably connected to the base, thereby facilitating the rotation of the second guide member relative to the base.

[0100]

[0121] In the 30th embodiment, which follows any one of the embodiments from the 23rd to the 29th embodiment, the first intermediate portion and the second intermediate portion are disposed between the surface of the shaft platform and the surface of the arched platform.

[0101]

[0122] In a 31st embodiment according to any one of the 23rd to 30th embodiments, 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 the 32nd embodiment, the device includes a needle assembly whose path is set to proceed through the pleural cavity toward a target at a known distance and which maintains its path while the needle assembly is advanced. The needle assembly is advanced through the pleural cavity at a first velocity toward a known distance. A force is applied to the proximal end of the needle assembly distally, and the force simultaneously injects a substance at a second velocity.

[0103]

[0124] For the purposes of describing and defining this disclosure, the term “substantially” is used herein to describe the degree of inherent uncertainty that may be given to any quantitative comparison, value, measurement, or other expression. The term “substantially” is also used herein to describe the degree to which a quantitative expression may deviate from the described standard without leading to a change in the fundamental function of the subject matter in dispute. Thus, the term “substantially” is used to describe the degree of inherent uncertainty that may be given to any quantitative comparison, value, measurement, or other expression, with reference to the composition of elements or features that may embody something that would theoretically be expected to exhibit an accurate correspondence or behavior, but falls slightly short of being accurate in practice.

[0104]

[0125] While this specification has described specific embodiments, it will be understood that a variety of other modifications and alterations can be made without departing from the spirit and scope of the claimed subject matter. Furthermore, while this specification has described various aspects of the claimed subject matter, these aspects do not necessarily need to be used in combination. Therefore, the attached claims are intended to encompass all modifications and alterations that fall within the scope of the claimed subject matter.

Claims

1. A medical sealant applicator device for the delivery of multi-component sealants, comprising a first body and a second body, wherein the first body is The device comprises a base, a first syringe plunger, a second syringe plunger, and a longitudinal channel laterally inserted between the first and second syringe plungers, wherein 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, and the second body is The device comprises a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber laterally inserted between the first and second syringe chambers, wherein the longitudinal fluid chamber has a proximal end and a distal end, the proximal end of the longitudinal fluid chamber is connected to the first and second syringe chambers respectively to provide fluid communication, and 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 the first proximal plunger piston of the first syringe plunger of the first body, The second syringe chamber of the second body has 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 translating within the longitudinal channel of the first body in response to the longitudinal translation of the second body relative to the first body.

2. The medical sealant applicator device according to claim 1, wherein when a force is applied to the proximal ends of the first syringe barrel and the second syringe barrel in the distal direction, 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, thereby causing the first syringe plunger and the second syringe plunger to move proximal to the first syringe barrel and the second syringe barrel, and the elongated needle to move distally away from the base in the distal direction opposite to the proximal direction.

3. The medical sealant applicator device according to claim 1, wherein the base of the first body includes a distal aperture, the longitudinal channel extends from the distal aperture in the first direction, 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 detachably connected 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 is The proximal end of the longitudinal fluid chamber is connected to the first syringe chamber by a first U-shaped connector, The proximal end of the longitudinal fluid chamber is connected to the second syringe chamber by a second U-shaped connector, A medical sealant applicator device according to any one of claims 1 to 3, comprising:

5. A medical sealant applicator device according to any one of claims 1 to 3, comprising a pair of finger-holding protrusions extending laterally from the base of the first body.

6. A medical sealant applicator device according to any one of claims 1 to 3, comprising a guide assembly for setting the depth of advancement of the elongated needle.

7. A medical sealant applicator device for the delivery of multi-component sealants, comprising a first body and a second body, wherein the first body is The device comprises a base, a first syringe plunger, a second syringe plunger, and a longitudinal channel laterally inserted between the first and second syringe plungers, wherein 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, and the second body is The device comprises a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber laterally inserted between the first and second syringe chambers, wherein the longitudinal fluid chamber has a proximal end and a distal end, the proximal end of the longitudinal fluid chamber is connected to the first and second syringe chambers respectively to provide fluid communication, and 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 the first proximal plunger piston of the first syringe plunger of the first body, The second syringe chamber of the second body has 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 moving in parallel within the longitudinal channel of the first body in response to the longitudinal translation of the second body relative to the first body. The aforementioned medical sealant applicator device is A guide assembly for setting a path toward the target position and maintaining the path while advancing the needle assembly and injecting the component. A medical sealant applicator device that further enhances this feature.

8. A medical sealant applicator device according to claim 7, wherein when a force is applied to the proximal ends of the first syringe barrel and the second syringe barrel in the distal direction, the force simultaneously overcomes the biasing force of the first biasing assembly of the first body and the second biasing assembly of the second body, thereby causing the first syringe plunger and the second syringe plunger to move proximal to the first syringe barrel and the second syringe plunger, and the elongated needle to move distally away from its base in the distal direction opposite to the proximal direction.

9. The medical sealant applicator device according to claim 7, wherein the base of the first body includes a distal aperture, the longitudinal channel extends from the distal aperture in the first direction, 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 detachably connected 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 is The proximal end of the longitudinal fluid chamber is connected to the first syringe chamber by a first U-shaped connector, The proximal end of the longitudinal fluid chamber is connected to the second syringe chamber by a second U-shaped connector, A medical sealant applicator device according to claim 7 or 8, comprising the above.

11. A medical sealant applicator device according to any one of claims 7 to 9, comprising a pair of finger-holding protrusions extending laterally from the base of the first body.

12. The medical sealant applicator device according to any one of claims 7 to 9, wherein the guide assembly sets the depth of the advancement of the elongated needle.

13. A component delivery system, A needle assembly having elongated needles having a proximal end and a distal end that are spaced apart from each other and define at least one fluid path between them, wherein the distal end has one or more fluid outlets connected to the at least one fluid path, A component delivery system comprising a medical sealant applicator device according to any one of claims 1 to 12, which is fluid-connected to the proximal end of the needle assembly.

14. The component delivery system according to claim 13, wherein when a force is applied to the proximal end of the syringe chamber in the distal direction, the force simultaneously overcomes the biasing forces of the first body and the second body, thereby causing the syringe plunger to move proximal to the second syringe chamber and the needle assembly to move distally away from the first body in the distal direction opposite to the proximal direction.

15. The component delivery system according to claim 13 or 14, wherein the needle assembly further comprises a connector hub detachably connected to the needle connector port, and the elongated needle extends from the second body through the first body.

16. The component delivery system according to any one of claims 13 to 15, further comprising a pair of finger-holding projections extending laterally from the first body.

17. The component delivery system according to any one of claims 13 to 15, further comprising a guide assembly for setting the depth of advancement of the elongated needle.

18. The guide assembly further comprises a depth adjustment component, a base and an angle adjustment component, The depth adjustment component is, A threaded shaft comprising a shaft head having a first shaft surface and a second shaft surface opposite to the first shaft surface, wherein the first shaft surface is in contact with the component delivery system, A collar having a female threaded portion that engages with the threaded shaft in the locking setting, and a slot that allows parallel movement of the threaded shaft along the central axis of the guide assembly in the adjustment setting, A shaft platform that contacts the second shaft surface of the shaft head, The arch-shaped platform connected to the aforementioned shaft platform, Equipped with, The angle adjustment component is, 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, wherein the first intermediate portion is disposed at a distance from the base and contacts the arch-shaped platform, A second guide member having a first end connected to the base, a second end connected to the base, and a second intermediate portion located between the first end and the second end of the second guide member, wherein the second intermediate portion is disposed at a distance from the base and contacts the shaft platform, The component delivery system according to claim 13, comprising:

19. The component delivery system according to claim 18, wherein the threaded shaft is movable along the central axis while in the adjustment setting.

20. The component delivery system according to claim 18, wherein the depth adjustment component is movably connected to the first guide member along a first rotation axis, and the second guide member is movably connected along a second rotation axis perpendicular to the first rotation axis.

21. The threaded shaft further comprises a threaded portion that defines the outer diameter, The slot defines an inner diameter that is larger than the outer diameter. The component delivery system according to claim 18.

22. The component delivery system according to claim 18, wherein the elongated needle is disposed within the shaft outlet of the threaded shaft.

23. The component delivery system according to claim 18, wherein the first end and the second end are rotatably connected to the base, thereby facilitating the rotation of the first guide member relative to the base.

24. The component delivery system according to claim 18, wherein the first end of the second guide member and the second end of the second guide member are rotatably connected to the base, thereby facilitating the rotation of the second guide member relative to the base.

25. The component delivery system according to claim 18, wherein the first intermediate portion and the second intermediate portion are disposed between the surface of the shaft platform and the surface of the arched platform.

26. The base is, The first side and the second side directly opposite the first side, A third side and a fourth side directly opposite the third side, Furthermore, The first side is connected to the first end of the first guide member, The second side is connected to the second end of the first guide member, The third side is connected to the first end of the second guide member, The fourth side is connected to the second end of the second guide member. The component delivery system according to claim 18.

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