Device for delivering multi-component sealant
By designing a multi-component sealant applicator device for lung biopsy, the problem of air and fluid entering the pleural space during lung biopsy is solved, precise control and delivery of sealant is achieved, the occurrence of pneumothorax is reduced, and medical treatment is improved Operational efficiency.
Patent Information
- Application Number
- CN202280096047.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2022-04-06
- Publication Date
- 2024-12-24
AI Technical Summary
During lung biopsy, it is difficult for medical professionals to effectively prevent or reduce air and fluid from entering the pleural space in the lungs, resulting in pneumothorax, and existing equipment can only use a single component sealant and cannot adjust the sealant delivery rate.
A medical sealant applicator device for delivering a multicomponent sealant is designed, including a first body and a second body having a base, a syringe plunger and a longitudinal channel, controlling the depth and angle of the needle assembly by a guide assembly , and adjust the flow rate of each component through the biasing assembly to ensure the correct proportion and flow rate of the sealant.
Accurate control and delivery of multi-component sealants is achieved, reducing the occurrence of pneumothorax, improving sealing effect, simplifying medical operations, and reducing hospital stays.
Smart Images

Figure CN119183364A_ABST
Abstract
Description
Technical Field
[0001] The present disclosure relates generally to the delivery of sealants for medical procedures and, more particularly, to devices, systems and methods for delivering multi-component sealants during medical procedures. Background Art
[0002] During a lung biopsy procedure, one potential concern for medical professionals is to prevent or reduce the possibility of air and / or fluid entering the pleural space within the lung. This condition, called a pneumothorax, can occur as a result of the puncture created during or after a lung biopsy procedure. Pneumothorax is a common occurrence and can result in a prolonged hospital stay. Additionally, subjects may require a chest tube in the event of a pneumothorax. Due to the various complications that can result from a pneumothorax, medical professionals may find it difficult to seal the puncture after the procedure.
[0003] Devices and methods have been used to attempt to seal punctures. However, these devices and methods are limited because medical professionals may only be able to use a single component sealant and / or may not have the ability to adjust the sealant delivery rate. Summary of the invention
[0004] According to one embodiment of the present disclosure, a medical sealant applicator device for delivering a multi-component sealant is provided, the medical sealant applicator device comprising a first body having a base, a first syringe plunger, a second syringe plunger and a longitudinal channel, the longitudinal channel being transversely disposed 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 from the base in a first direction. The first syringe plunger has a first free end, the first free end having a first proximal plunger piston. The second syringe plunger has a second free end, the second free end having a second proximal plunger piston. The second body of the medical sealant applicator device has a first syringe chamber, a second syringe chamber and a longitudinal fluid chamber transversely disposed between the first syringe chamber and the second syringe chamber. The longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is connected to each of the first syringe chamber and the second syringe chamber in a fluid communication manner. 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 to slidably receive 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 to slidably receive 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 translatable in the longitudinal channel of the first body in response to longitudinal translation of the second body relative to the first body.
[0005] In another embodiment, a medical sealant applicator device for delivering a multi-component sealant is provided, the medical sealant applicator device 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 disposed transversely 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 from the base in a first direction. The first syringe plunger has a first free end, the first free end having a first proximal plunger piston. The second syringe plunger has a second free end, the 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 disposed transversely between the first syringe chamber and the second syringe chamber. The longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is connected to each of the first syringe chamber and the second syringe chamber in a fluid communication manner. 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 to slidably receive 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 to slidably receive a 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 the longitudinal translation of the second body relative to the first body. The medical sealant applicator device also includes: a guide assembly. The guide assembly sets a trajectory toward a target location and maintains the trajectory when the needle assembly is advanced and a component is injected.
[0006] In another embodiment, a method is provided that includes setting a trajectory of a needle assembly through a pleural space toward a target at a known distance and maintaining the trajectory while advancing the needle assembly. The method also includes advancing the needle assembly through the pleural space to the known distance at a first rate. The method also includes applying a force in a distal direction toward a proximal end of the needle assembly, wherein the force simultaneously injects a substance at a second rate.
[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, which includes a proximal end and a distal end, which are spaced apart from each other by a distance and define at least one fluid path therebetween. The distal end includes one or more fluid outlets connected to at least one fluid path. The applicator is fluidly connected to the proximal end of the needle assembly. The applicator includes a first body, which includes a first biasing assembly connected to the needle assembly. The first body biases the needle assembly in a proximal direction relative to the applicator. The second body includes a syringe chamber and a syringe plunger, the syringe chamber having a needle connector port connected to the needle assembly fluid at its proximal end, the syringe plunger being arranged in the syringe chamber at its distal end and movable in the syringe chamber. The 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] These and additional features provided by the embodiments described herein will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Figure 1 is a perspective view of a component delivery system including a protective spacer according to one or more embodiments shown and described herein;
[0010] Figure 2 According to one or more embodiments shown and described herein Figure 1 A front view of a component delivery system;
[0011] Figure 3A According to one or more embodiments shown and described herein, Figure 2 A detailed view of the component delivery system taken at section 3A in FIG.
[0012] Figure 3B is a detailed view of a component delivery system according to one or more embodiments shown and described herein, with selected components omitted;
[0013] Figure 4 is a perspective view of a guide assembly according to one or more embodiments shown and described herein;
[0014] Figure 5 is a front view of a threaded shaft of a guide assembly according to one or more embodiments shown and described herein;
[0015] Figure 6 According to one or more embodiments shown and described herein Figure 5 A top view of a threaded shaft;
[0016] Figure 7 According to one or more embodiments shown and described herein Figure 4 a perspective view of a guide assembly of the invention with selected components omitted;
[0017] Figure 8 According to one or more embodiments shown and described herein Figure 4 Another perspective view of the guide assembly of FIG. 1 with selected components omitted;
[0018] Fig. 9 According to one or more embodiments shown and described herein Figure 4 Another perspective view of the guide assembly of the invention with selected components omitted;
[0019] Fig.10 According to one or more embodiments shown and described herein, Figure 4 A detailed view of the guide assembly taken at section 10 in FIG.
[0020] Fig.11 is a perspective view of a component delivery system and guide assembly in a first position according to one or more embodiments shown and described herein; and
[0021] Fig.12 is a perspective view of a component delivery system and guide assembly in a second position according to one or more embodiments shown and described herein. DETAILED DESCRIPTION
[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 numerals will be used throughout the drawings to refer to the same or like parts. Directional terms used herein, such as up, down, right, left, front, back, top, bottom, distal, and proximal, are made only with reference to the drawings as drawn and do not imply absolute directions.
[0023] Ranges herein 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 a particular value and / or to another particular value. Similarly, when a value is expressed as an approximation by using the antecedent "about," it will be understood that the particular value forms another embodiment. It should also be understood that the endpoints of each range are important both relative to the other endpoint and independently of the other endpoint.
[0024] Unless otherwise expressly stated, any method described herein shall not be construed as requiring that its steps be performed in a particular order, nor requiring a particular orientation of any apparatus. Thus, in the absence of a method claim actually reciting the order in which its steps are to be followed, or any apparatus claim actually reciting the order or orientation of individual components, or in the absence of other specific statements in the claims or specification that the steps are limited to a particular order, or in the absence of a particular order or orientation of components of an apparatus, no order or orientation is inferred in any way. This applies to any possible non-express basis for interpretation, including: logical issues regarding the arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation; the number or type of embodiments described in the specification.
[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those of ordinary skill in the art to which the present disclosure belongs. The terms used in the description herein are only used to describe specific embodiments and are not intended to be limiting. As used in the specification and the appended claims, the singular forms of "a", "an", and "the" are also intended to include the plural forms unless the context clearly indicates otherwise.
[0026] As used herein, the terms "horizontal", "vertical", "distal" and "proximal" are relative terms only, indicating only a general relative orientation and not necessarily vertical. For convenience, these terms may also be used to refer to the directions used in the accompanying drawings, which are used only as a convention and are not intended to be features of the devices shown. The present disclosure and embodiments thereof to be described herein may be used in any intended direction. In addition, 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 of "a", "an", and "the" include plural referents unless the context clearly indicates otherwise. Thus, for example, a reference to "a" component includes aspects having two or more such components unless the context clearly indicates otherwise.
[0027] During a lung biopsy procedure, one potential concern for medical professionals is the possibility of air and / or fluid entering the pleural space within the lung. To mitigate this, the present disclosure is directed to a component delivery system that seals the path formed by the needle assembly when the needle assembly is injected into the 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 so that the multi-component sealant has the correct ratio. The component delivery system can be placed in a guide assembly. The guide assembly is placed on 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.
[0028] The component delivery system has the following technical effects: In response to the application of the component delivery system by a medical professional, the first body of the component delivery system is pushed toward the second body of the component delivery system. The second body includes each component of the multi-component sealant. After the second body is pushed into the first body, each component is dispensed from the first body to the mixing chamber. In the mixing chamber, the multi-component sealant begins to mix and is then dispensed from the needle assembly of the component delivery system.
[0029] The guide assembly has the technical effect of controlling the depth and angle of the needle assembly prior to injection into a subject. The depth control of the guide assembly moves the needle assembly in a single direction. The angle control changes the entry angle of the needle assembly. Adjusting the angle of the needle assembly does not affect the depth of the guide assembly.
[0030] 1. Component delivery system
[0031] Reference Figures 1 to 3B , according to some embodiments, a component delivery system 100 is shown. The component delivery system 100 can be used during a medical procedure and / or a medical study. The component delivery system 100 includes an applicator 101, a mixing chamber 120, and a needle assembly 122 fluidly coupled to the applicator 101.
[0032] The applicator 101 stores each component of the multi-component sealant. In response to receiving a biasing force, the applicator 101 provides each component 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 located 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 located 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 each component of the multi-component to the mixing chamber 120 in response to receiving a biasing force. Specifically, the biasing force causes each component of the multi-component sealant to flow from the applicator 101 to the needle assembly 122 while maintaining a controlled flow rate.
[0033] Reference Figure 3B , the first body 103 includes a base 103a, a first syringe plunger 103b, a second syringe plunger 103c, a first finger grip protrusion 117a, and a second finger grip protrusion 117b. As depicted, the base 103a defines an elliptical shape, but other geometric shapes are also contemplated and possible (e.g., rectangular, triangular, hexagonal). The base 103a defines a distal hole extending through the depth of the base 103a and is centered along the central axis 105, thereby providing a space for the mixing chamber 120 and the needle assembly 122 to extend through. The base 103a can be constructed of plastic, metal, or any other suitable material.
[0034] The first syringe plunger 103b and the second syringe plunger 103c extend from the first surface of the base 103a and are further located on opposite sides 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., adhered, fastened, plastic welded) or integrated with the base 103a (e.g., machined, molded, formed, plastic injected). Each of the first syringe plunger 103b and the second syringe plunger 103c can be parallel to the central axis 105.
[0035] 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 can be made of rubber, plastic or any suitable material. The first syringe plunger 103b contacts the first component of the multi-component sealant through the first plunger top 103d, and the second syringe plunger 103c contacts the second component of the multi-component sealant through the second plunger top 103e. In response to the force applied to the first body 103, each of the first syringe plunger 103b and the second syringe plunger 103c applies a force on the corresponding component of the multi-component sealant. As shown in the figure, the first syringe plunger 103b and the second syringe plunger 103c are piston-type rods defining a conical top. However, any suitable syringe plunger can be used.
[0036] The first finger grip protrusion 117a and the second finger grip protrusion 117b extend laterally from the first body 103 in a direction perpendicular to the central axis 105. The first finger grip protrusion 117a and the second finger grip protrusion 117b each define a curved profile. The curved profile is shaped to provide an ergonomic feel to the medical professional, so that the first finger of the medical professional can apply force on the first finger grip protrusion 117a or remain on the first finger grip protrusion 117a, and the second finger of the medical professional can apply force on the second finger grip protrusion 117b or remain on the second finger grip protrusion 117b. Although depicted as a curved profile, other geometric shapes are also expected and possible. For example, the finger grip protrusions 117a, 117b can be closed circles.
[0037] A force may be applied in a proximal direction along central axis 105 and toward second body 102. In embodiments, first and second finger grip projections 117a, 117b may be used to hold (eg, stabilize) base 103a when applying applicator 101. In some embodiments, more than two finger grip projections are used.
[0038] The second body 102 is positioned at an axial end of the applicator 101 opposite the first body 103. The second body 102 is centered about a central axis 105 and may be constructed of any suitable material (eg, plastic, metal, glass, etc.).
[0039] 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 engagement feature 116 .
[0040] The engagement feature 116 is located at the second axial end of the applicator 101 and is centered on the central axis 105. As shown, the engagement feature 116 defines a flat profile, however, other geometric profiles are also expected and possible (e.g., concave profile, convex profile). The engagement feature 116 is shaped to provide an ergonomic profile so that the fingers of a medical professional can easily apply force to the engagement feature 116 to apply force to the second body 102 along the central axis 105 toward the first body 103. Since the engagement feature 116 is centered on the central axis 105 and is thus concentric with the second body 102, the force applied to the engagement feature 116 is equally distributed to the second body 102. The engagement feature 116 can define a plurality of ridges to help the medical professional engage with the engagement feature 116.
[0041] To apply the multi-component delivery system 100, a force is applied to the applicator 101. In an embodiment, the force is applied to the engagement feature 116, causing the second body 102 to translate toward the first body 103. In an embodiment, the force is applied to the first finger grip protrusion 117a and the second finger grip protrusion 117b, causing the first body 103 to translate toward the second body 102.
[0042] The first syringe barrel 104 contains the first component of the multi-component sealant. The first syringe barrel 104 can be translucent so that the medical professional can see the first component; or opaque to protect the first component from light. The first syringe barrel 104 extends along an axis parallel to the central axis 105.
[0043] The first syringe plunger 103b extends into the first syringe bore 104a of the first syringe barrel 104. The sizes of the first syringe plunger 103b and the first syringe bore 104a are matched so that the first plunger top 103d of the first syringe plunger 103b forms an airtight seal in the first syringe barrel 104. This airtight seal prevents the first component located in the first syringe barrel 104 from leaking out of the first syringe barrel 104 and prevents the first component from being exposed to the atmosphere. The inner diameter of the first syringe barrel 104 can be adjusted to control the rate at which the component leaves the first syringe barrel 104 during application. For example, if the ratio for producing a multi-component seal requires an additional amount of the first component, the inner diameter of the first syringe barrel 104 can be increased. In addition, if the ratio for producing a multi-component seal requires a smaller amount of the first component, the inner diameter of the first syringe barrel 104 can be reduced.
[0044] In response to the force applied to the applicator 101, a biasing force is applied by the first syringe plunger 103b on the first component in the first syringe barrel 104. In other words, in response to the engagement feature 116 being pushed toward the first body 103 and / or the finger grip projections 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 within the first syringe barrel 104 out of the first syringe barrel 104.
[0045] The first syringe barrel 104 is connected to the first u-shaped connector 106 and is fluidically connected thereto. The first u-shaped connector 106 extends laterally from the first syringe barrel 104 toward the central axis 105 (e.g., perpendicular to 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 leaving the first syringe barrel 104 via the first syringe plunger 103b, the first component is fluidically provided to the first u-shaped connector 106. By defining a u-shaped fluid path, the first component is redirected from advancing toward the second body 102 (e.g., in the first syringe barrel 104) to now advancing toward the first body 103 (e.g., after leaving the first u-shaped connector 106). Due to its curved shape, the first u-shaped connector 106 prevents a bottleneck from occurring in the fluid path. In this way, the fluid can leave the applicator 101 at a constant flow rate. As the first component continues to advance, it can leave the first u-shaped connector 106.
[0046] The first u-shaped connector 106 can be coupled to the first longitudinal barrel 108 and fluidically coupled thereto. In an embodiment, the first u-shaped connector 106 is integrated into 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 directed to the first body 103. The first longitudinal barrel 108 can be made of plastic, glass or any other suitable material.
[0047] The second syringe barrel 110 contains the second component of the multi-component sealant. The second syringe barrel 110 can be translucent so that the medical professional can see the second component; or opaque to protect the second component from light. The second syringe barrel 110 extends along an axis parallel to the central axis 105.
[0048] The second syringe plunger 103c extends into the second syringe bore 110a of the second syringe barrel 110. The sizes of the second syringe plunger 103c and the second syringe bore 110a are matched so that the second plunger top 103e of the second syringe plunger 103c forms an airtight seal in the second syringe barrel 110. This airtight seal prevents the second component located in the second syringe barrel 110 from leaking out of the second syringe barrel 110 and prevents the second component 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 leaves the second syringe barrel 110 during application. For example, if the ratio for producing a multi-component seal requires an additional amount of the second component, the inner diameter of the second syringe barrel 110 can be increased. In addition, if the ratio for producing a multi-component seal requires a smaller amount of the second component, the inner diameter of the second syringe barrel 110 can be reduced.
[0049] In response to the force applied to the applicator 101, a biasing force is applied by the second syringe plunger 103c on the second component in the second syringe barrel 110. In other words, in response to the engagement feature 116 being pushed toward the first body 103 and / or the finger grip projections 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 within the second syringe barrel 110 out of the second syringe barrel 110.
[0050] The second syringe barrel 110 is connected to the second u-shaped connector 112 and is fluidly connected thereto. The second u-shaped connector 112 extends laterally from the second syringe barrel 110 toward the central axis 105 (e.g., perpendicular to the central axis 105). In an embodiment, the second u-shaped connector 112 is integrated into the second syringe barrel 110. In response to the second component leaving the second syringe barrel 110 via the second syringe plunger 103c, the second component is fluidically provided to the second u-shaped connector 112. By defining a u-shaped fluid path, the second component is redirected from traveling toward the second body 102 (e.g., in the second syringe barrel 110) to traveling toward the first body 103 now (e.g., after leaving the second u-shaped connector 112). The second u-shaped connector 112 prevents a bottleneck from occurring in the fluid path due to its curved shape. In this way, the fluid can leave the applicator 101 at a constant flow rate. As the second component continues to travel, it can leave the second u-shaped connector 112.
[0051] The second u-shaped connector 112 can be coupled to the second longitudinal barrel 114 and fluidly coupled thereto. In an embodiment, the second u-shaped connector 112 is integrated into 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 directed to the first body 103. The second longitudinal barrel 114 can be made of plastic, glass or any other suitable material.
[0052] refer to FIG. 3A to FIG. 3B , the mixing chamber 120 is shown as being located between the base 103a, the first longitudinal barrel 108, and the second longitudinal barrel 114. The mixing chamber 120 may be centered along the central axis 105.
[0053] As shown in the figure, the sidewall of mixing chamber 120 limits the profile that tapers inwardly, so that the area that mixing inlet 120a limits is greater than mixing outlet 120b.Like this, the first component and the second component that are respectively received by the first longitudinal tube 108 and the second longitudinal tube 114 begin to contact each other, while minimizing the chance of bottleneck (blocking) occurring in mixing chamber 120.But other shapes are also predictable and possible.For example, in an embodiment, the area of mixing outlet 120b can be greater than or equal to the area of mixing inlet 120a.In these embodiments, the sidewall of mixing chamber 120 can limit the profile that tapers outwardly or can be parallel.Mixing chamber 120 can be made of any suitable material, such as plastics, pottery, glass, metal or any other suitable material.
[0054] 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 traveling within the first longitudinal barrel 108 and the second component traveling 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, in the mixing chamber 120, the first component and the second component may begin to contact and mix together.
[0055] In some embodiments, the first component and the second component do not mix in the mixing chamber 120. In some embodiments, the first component and the second component do begin to mix in the mixing chamber 120 and begin to form a multi-component sealant. In some embodiments, the first component and the second component completely mix in the mixing chamber 120 to form a multi-component sealant.
[0056] In some 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 together so that the first component and the second component are in contact within the combined first longitudinal barrel 108 and the second longitudinal barrel 114. Continuing in these embodiments, the first longitudinal barrel 108 and / or the second longitudinal barrel 114 define a spiral profile (not shown) to contact the first component to the second component, or to contact the second component to the first component.
[0057] Reference Figure 1 , the component delivery system 100 is shown with a removable stopper 118. To prevent accidental use of the applicator 101, a medical professional may assemble the removable stopper 118 to the component delivery system 100. The removable stopper 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 stopper 118 may be placed on the applicator 101 until the component delivery system 100 is ready for use by a medical professional. In some embodiments, the removable stopper 118 is integrated into (e.g., molded, cast) the component delivery system 100 and includes a removable tab to allow the removable stopper 118 to be easily removed from the component delivery system 100. The removable stopper 118 may be made of plastic, ceramic, metal, or any suitable material.
[0058] 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 placed on the first syringe plunger 103b and is positioned between the base 103a and the first syringe barrel 104. In addition, the second stopper element 118b is placed on the second syringe plunger 103c and is positioned between the base 103a and the second syringe barrel 110. In some embodiments, each stopper element 118a, 118b may be removably coupled to each syringe barrel 104, 110 via a snap-fit connection or any 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 caused by the first stopper element 118a and the second stopper element 118b. Then, when the component delivery system 100 is intended to be used, the removable stopper 118 can be disassembled. In some embodiments, the removable stop 118 may include only one of the first stop element 118a or the second stop element 118b.
[0059] refer to Figure 2, needle assembly 122 is shown to include a connector seat 122a and an elongated needle 122b. Needle assembly 122 is centered along central axis 105 and extends along central axis 105. Needle assembly 122 dispenses the multi-component sealant from applicator 101 to a target location within a subject. Needle assembly 122 is located at an axial end of component delivery system 100, which is opposite to an opposite axial end of component delivery system 100 (e.g., an end where engagement feature 116 is located). Needle assembly 122 can be any available needle assembly used in medical applications. When needle assembly 122 enters the target location of the subject, needle assembly 122 begins dispensing the multi-component sealant.
[0060] Connector seat 122a is connected with mixing outlet 120b, and is connected with its fluid. Connector seat 122a is centered on central axis 105. As shown, connector seat 122a is embedded in mixing outlet 120b. However, other fastening methods can be used to connect connector seat 122a to mixing outlet 120b, such as fastening threads, bonding, etc. In some embodiments, connector seat 122a is integrated (e.g., cast, formed, machined, molded) into mixing chamber 120. As the first component, the second component and / or the multi-component sealant continue to advance, they leave from mixing outlet 120b and enter connector seat 122a. In some embodiments, the first component and the second component can start mixing or continue mixing in connector seat 122a.
[0061] The elongated needle 122b is coupled to the connector seat 122a and fluidly coupled. The elongated needle 122b is centered on the central axis 105 and extends along the central axis 105. In some embodiments, the connector seat 122a can be integrated into the connector seat 122a. In some embodiments, the elongated needle 122b receives a fully mixed multi-component sealant from the connector seat 122a. In some embodiments, the first component and the second component can begin to mix or continue to mix within the elongated needle 122b.
[0062] The elongated needle 122b defines a needle outlet 122c. The needle outlet 122c is located at an axial end of the elongated needle 122b opposite the connector hub 122a. The multi-component sealant is dispensed from the elongated needle 122b to a target location within a subject's body via the needle outlet 122c.
[0063] The component delivery system 100 delivers the multi-component sealant to the subject when the needle assembly of the component delivery system 100 is injected into the pleural space of the subject's lung. In this way, the medical professional seals the path of the needle assembly during the injection of the needle. When the needle assembly 122 is injected into the pleural space of the subject's lung, each component of the multi-component sealant leaves the corresponding syringe barrel in response to the component delivery system 100 being subjected to the applied force. Each component of the multi-component sealant is then mixed within the component delivery system 100 to form the multi-component sealant. The multi-component sealant is then dispensed from the needle assembly 122.
[0064] In this way, a multi-component sealant can be used because the configuration of the component delivery system 100 provides a controlled ratio of each component. This is advantageous because multi-component sealants can be superior to single-component sealants in terms of sealing. In addition, the rate of the component delivery system 100 can be dispensed in a controlled manner. This is advantageous because it reduces the possibility of a medical professional applying too much or too little sealant to a subject.
[0065] 2. Boot system
[0066] Reference Figure 11 to Figure 12 , system 400 is shown with component delivery system 100 and guide assembly 420. Although described with component delivery system 100, any syringe assembly and / or needle assembly may be used with guide assembly 420.
[0067] Component delivery system 100 is placed in guide assembly 420. Guide assembly 420 is centered on guide axis 401a. When a medical professional is ready to dispense a multi-component sealant to a subject during a medical procedure and / or medical study, guide assembly 420 is placed on the subject's skin so that needle assembly 122 can enter the skin and translate toward the target treatment area.
[0068] Prior to injecting the multi-component sealant, guide assembly 420 provides a medical professional with control over the placement of component delivery system 100. Medical professionals can use guide assembly 420 to control the depth of component delivery system 100 so that they can determine the desired depth adjustment of needle assembly 122 before needle assembly 122 enters a subject. Component delivery system 100 defines central axis 105. Guide assembly 420 allows depth adjustment along central axis 105 of component delivery system 100.
[0069] Medical professionals can also use guide assembly 420 to determine the angle of component delivery system 100 so that they can control the entry angle 401c of needle assembly 122 before needle assembly 122 enters a subject. Entry angle 401c can be defined by comparing the deviation of central axis 105 from guide axis 401a. Figure 4As shown, the entry angle 401c of the component delivery system 100 is depicted in a first position of the system 400. Figure 5 As shown, the guide assembly 420 is in the second position after being adjusted to achieve a different entry angle 401c.
[0070] Continue to refer Figure 11 to Figure 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 (eg, Figures 5 and 6 4. 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, but other shapes are also contemplated and possible. For example, the base surface 103f can have a protruding profile, and the shape and size of the first shaft surface 422a can be designed to define a receiving cavity to receive the protruding profile.
[0071] In some embodiments, the base surface 103f includes engagement features (e.g., snap-fit connectors, fasteners) to removably secure 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 unintentional movement (e.g., looseness) in the system 400. This is advantageous because it provides a medical professional using the system 400 with greater control prior to injecting the multi-component sealant into a subject during a procedure.
[0072] When the component delivery system 100 is placed in 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 outlet 422c.
[0073] Reference Figure 4 The depth adjustment component of the guide assembly 420 includes a threaded shaft 422 , a shaft collar 424 and a shaft platform 426 . The angle adjustment component of the guide assembly 420 includes an arched platform 427 , a first guide member 428 and a second guide member 430 .
[0074] 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 outlet 422c, and a second shaft surface 422d. The second shaft surface 422d is positioned on the shaft head of the threaded shaft 422 opposite to the first shaft surface 422a. As shown, the threaded portion 422b defines an externally disposed thread. In some embodiments, the threaded portion 422b defines an internally placed thread. The threaded shaft 422 can be made of metal, plastic, etc. The size of the shaft outlet 422c allows various needle assembly specifications to be used.
[0075] Reference Figures 7 to 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 opposite to the opposite side of the second collar surface 424d. When the threaded shaft 422 is assembled into the collar 424, the second shaft surface 422d contacts the first collar surface 424a. At the expected depth position, the threaded portion 422b of the threaded shaft 422 can engage the internal thread 424b of the collar 424. The internal thread 424b of the collar 424 can then lock the threaded shaft 422 in place. In addition, the internal thread 424b allows the threaded shaft 422 to be finely adjusted by tightening the threaded shaft 422 along the central axis 105.
[0076] In this way, the medical professional can adjust the depth position of the component delivery system 100 by first sliding the threaded shaft 422 in the collar 424 in the adjustment position and then engaging the internal threads 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 make fine adjustments by tightening the threaded shaft 422 along the central axis 105. Regardless of the adjustments made to obtain the desired entry angle 401c, the depth of the needle assembly 122 to the subject's skin is maintained. In embodiments where the threaded portion 422b of the threaded shaft 422 is placed internally, the threads of the collar 424 can be located on the outer surface of the collar 424.
[0077] The shaft platform 426 includes a shaft surface 426a, an engagement lug 426b, a groove 426c, and a shaft outer surface 426d. The shaft platform 426 is partially located in the sleeve 424c of the collar 424 and is connected to the collar 424. In some embodiments, the collar 424 is integrated with the shaft platform 426. When the threaded shaft 422 is placed in the collar 424, it is simultaneously placed in the groove 426c of the shaft platform 426. The groove 426c extends through the depth of the shaft platform 426. The shape and size of the inner diameter of the groove 426c are designed so that it exceeds the outer diameter of the threaded portion 422b of the threaded shaft 422. In this way, before engaging the internal thread 424b of the collar 424, the threaded shaft 422 can be slidably moved along the length of the shaft platform 426 and the collar 424. This is advantageous because it allows for large depth adjustments without the need to completely tighten or loosen the threaded shaft 422 along the central axis 105. As depicted, the shaft outer surface 426d of the shaft platform 426 is circular, but other geometric profiles are also contemplated and possible.
[0078] The arched platform 427 includes an engagement groove 427a, an arched surface 427b, and an arched railing 427c. The arched platform 427 surrounds the outer periphery of the threaded portion 422b of the threaded shaft 422. The engagement groove 427a is formed in the arched surface 427b. The engagement tab 426b of the shaft platform 426 couples the shaft platform 426 to the arched platform 427 through the engagement groove 427a. The arched railing 427c is located on opposite sides of the arched surface 427b and extends at least partially along the opposite sides of the arched surface 427b.
[0079] In response to the force applied to the arched rail 427c, the arched platform 427 responsively moves in the direction of the applied force. When the arched platform 427 is coupled to the shaft platform 426, the force causes the shaft platform 426 and the shaft collar 424 to translate. This causes the component delivery system 100 positioned in the shaft platform 426 and the shaft collar 424 to translate.
[0080] Reference again Figure 4 , showing a first guide member 428 and a second guide member 430. The first guide member 428 and the second guide member 430 allow adjustment of an 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 each being rotatable on a rotation axis.
[0081] The first end 428a of the first guide member 428 is coupled to the first side 432a of the base 432. The second end 428b of the first guide member 428 is coupled to the 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 located at opposite positions of the base 432.
[0082] The first guide member 428 forms an arched profile between the first end 428a and the second end 428b. The first intermediate portion 428d of the first guide member 428 is located between the first end 428a and the second end 428b. The first intermediate portion 428d contacts the arched surface 427b of the arched platform 427. In addition, the first intermediate portion 428d contacts the arched railing 427c of the arched platform 427. The first guide member 428 rotates along a first rotation axis perpendicular to the length of the first guide member 428 in response to receiving a force.
[0083] To adjust the entry angle 401c of the component delivery system 100, the medical professional may apply a force on any component of the component delivery system 100 or the guide assembly 420. When the components of the guide assembly 420 are coupled to each other, the input force is ultimately transmitted to the arched railing 427c of the arched platform 427. The force on the arched railing 427c is transmitted to the first intermediate portion 428d of the first guide member 428. In response to receiving the force on the first intermediate portion 428d, the first guide member 428 may rotate on the first rotation axis. The first guide member 428 may be constructed of plastic, metal, or any other suitable material.
[0084] The first end 430a of the second guide member 430 is coupled to the third side 432c of the base 432. The second end 430b of the second guide member 430 is coupled to the 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 located at opposite positions of the base 432.
[0085] The second guide member 430 forms an arched profile between the first end 430a and the second end 430b. The second middle portion 430d of the second guide member 430 is located between the first end 430a and the second end 430b. The second middle portion 430d of the second guide member 430 contacts the second collar surface 424d of the collar 424. In addition, the first middle portion 428d contacts the shaft outer surface 426d of the shaft platform 426. The second guide member 430 rotates along a second rotation axis perpendicular to the length of the second guide member 430 in response to receiving a force.
[0086] To adjust the entry angle 401c of the component delivery system 100, the medical professional may apply a force on any component of the component delivery system 100 or the guide assembly 420. When the components of the guide assembly 420 are coupled to each other, the input force is ultimately transmitted to the shaft outer surface 426d of the shaft platform 426. The force on the shaft outer surface 426d is transmitted to the second middle portion 430d of the second guide member 430. In response to receiving the force on the second middle portion 430d, the second guide member 430 may rotate on the second rotation axis. The second guide member 430 may be constructed of plastic, metal, or any other suitable material.
[0087] The first guide member 428 and the second guide member 430 cooperate to adjust the entry angle 401c of the component delivery system 100. The first guide member 428 is adjusted on a first rotational axis and the second guide member 430 is adjusted on a second rotational axis. Thus, a medical professional can move the first guide member 428 and / or the second guide member 430 to achieve a desired entry angle 401c of the component delivery system 100. Adjustment of 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 needle assembly 122 of the injection component delivery system 100 having both depth and angle control.
[0088] Reference Fig.10 , showing a detailed portion of a base 432 and a second guide member 430. Specifically, a third side 432c of the base 432 and a first end 430a of the second guide member 430 are shown. As shown, a shaft 434 of the first end 430a of the second guide member 430 extends within a hole in the third side 432c and is coupled to the hole in the third side 432c. The first end 430a is coupled to the third side 432c by an interference fit. In other words, the third side 432c fixes the shaft 434 by friction. The shape and size of the third side 432c and the shaft 434 are designed so that when the component delivery system 100 is used or when the depth of the threaded shaft 422 is adjusted, the position of the first guide member 428 is stationary.
[0089] The shape and size of the third side 432c and the shaft 434 may be further designed so that the first guide member 428 is adjusted in response to receiving a force having a rotational direction. The shape and size of 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 designed in a manner similar to the first side 432a of the second guide member 430. Therefore, each of the first end 428a and the second end 428b of the first guide member 428 and the first end 430a and the second end 430b of the second guide member 430 may include a shaft 434 located within the corresponding base end.
[0090] Therefore, the first side 432a, the second side 432b, and the fourth side 432d of the base 432 are designed to be similar in shape and size to the third side 432c.
[0091] Base 432 is centered on guide shaft 401a and is placed on the subject. Base 432 can be made of any suitable material for medical applications, such as plastic, metal, etc. As shown, base 432 defines a disc-shaped geometry. However, other geometries are also contemplated and possible. For example, base 432 can define a curved profile so that it can be better applied to a curved surface of a subject (e.g., an arm of a subject, a leg of a subject). Base 432 defines a central hole so that the needle assembly 122 of component delivery system 100 can contact the skin of the subject.
[0092] A component delivery system is disclosed herein, which has a first body and a second body, the first body and the second body comprising each component of a multi-component sealant. When the engagement feature of the component delivery system is applied, the first body moves 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.
[0093] Also disclosed herein is a guide assembly that can 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 injection into a subject. The depth control of the guide assembly moves the component delivery system in a single direction, while the angle control controls the angle of entry 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.
[0094] In summary, the present disclosure may be viewed as relating to the following aspects. In a first aspect, a medical sealant applicator device for delivering a multi-component sealant comprises a first body having a base, a first syringe plunger, a second syringe plunger, and a longitudinal passage disposed transversely 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 from the base in a first direction. 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 applicator device has a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber disposed transversely between the first syringe chamber and the second syringe chamber. The longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is connected in fluid communication with each of the first syringe chamber and the second syringe chamber. 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 to slidably receive 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 to slidably receive 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 translatable in the longitudinal channel of the first body in response to longitudinal translation of the second body relative to the first body.
[0095] In a second aspect, in view of the first aspect, when a force is applied to the proximal ends of the first syringe barrel and the second syringe barrel in a distal direction, the force simultaneously overcomes the biasing forces of the first biasing component of the first body and the second biasing component of the medical sealant applicator device, thereby 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 barrel, and the elongated needle to move distally away from the base in a distal direction opposite to the proximal direction.
[0096] In a third aspect or the second aspect, in view of the first aspect, the base of the first body includes a distal hole, wherein the longitudinal channel extends from the distal hole in a first direction, wherein the medical sealant applicator device also includes a needle assembly having a connector seat and a slender needle extending from the connector seat, the connector seat being removably coupled to the distal needle connector port of the second body, wherein the slender needle extends from the second body through the distal hole of the base of the first body.
[0097] In a fourth aspect, according to any of the preceding aspects, the second body comprises: a first U-shaped connector, which connects the proximal end of the longitudinal fluid chamber with the first syringe chamber in a fluid-connected manner; and a second U-shaped connector, which connects the proximal end of the longitudinal fluid chamber with the second syringe chamber in a fluid-connected manner.
[0098] In a fifth aspect, according to any one of the first to fourth aspects, the medical sealant applicator device comprises: a pair of finger grip projections extending laterally from the base of the first body.
[0099] 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 advancement depth of the elongated needle.
[0100] In a seventh aspect, a medical sealant applicator device for delivering 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 disposed transversely 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 from the base in a first direction. The first syringe plunger has a first free end, which has a first proximal plunger piston. The second syringe plunger has a second free end, which has a second proximal plunger piston. The second body has a first syringe chamber, a second syringe chamber and a longitudinal fluid chamber disposed transversely between the first syringe chamber and the second syringe chamber. The longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is connected to each of the first syringe chamber and the second syringe chamber in a fluid communication manner. 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 to slidably receive 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 to slidably receive the second proximal plunger piston of the second syringe plunger of the first body. In response to the longitudinal translation of the second body relative to the first body, the distal needle connector port of the longitudinal fluid chamber of the second body can translate in the longitudinal channel of the first body. The guide assembly sets a trajectory toward the target position and maintains the trajectory when advancing the needle assembly and the injection component.
[0101] In an eighth aspect, according to the seventh aspect, when a force is applied to the proximal ends of the first syringe barrel and the second syringe barrel in a 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 in a proximal direction relative to the first syringe barrel and the second syringe plunger, and the slender needle moves distally away from the base in a distal direction opposite to the proximal direction.
[0102] In a ninth aspect, according to the seventh aspect or the eighth aspect, the base of the first body includes a distal hole, wherein the longitudinal channel extends from the distal hole in a first direction, and the medical sealant applicator device also includes a needle assembly, the needle assembly having a connector seat and a slender needle extending from the connector seat, the connector seat being removably connected to the distal needle connector port of the second body, wherein the slender needle extends from the second body through the distal hole of the base of the first body.
[0103] In a tenth aspect, according to any one of aspects seven to nine, the second body includes a first U-shaped connector, which connects the proximal end of the longitudinal fluid chamber with the first syringe chamber in a fluid-connected manner; and a second U-shaped connector, which connects the proximal end of the longitudinal fluid chamber with the second syringe chamber in a fluid-connected manner.
[0104] In an eleventh aspect, according to any one of the seventh to tenth aspects, a pair of finger grip projections extend laterally from the base of the first body.
[0105] In a twelfth aspect, according to any one of the seventh to eleventh aspects, the guide assembly sets the advancement depth of the elongated needle.
[0106] In a thirteenth aspect, a method includes setting a trajectory of a needle assembly through a pleural space toward a target at a known distance and maintaining the trajectory while advancing the needle assembly. The method also includes advancing the needle assembly through the pleural space to the known distance at a first rate. The method also includes applying a force in a distal direction toward a proximal end of the needle assembly, wherein the force simultaneously injects a substance at a second rate.
[0107] In a fourteenth aspect, according to the thirteenth aspect, the advancement of the needle assembly is performed synchronously with the application of the force.
[0108] In a fifteenth aspect, according to the thirteenth or fourteenth aspect, the first velocity of the needle assembly is related to a second velocity of the injected substance.
[0109] In a sixteenth aspect, according to the fifteenth aspect, the correlation of the first rate of the needle assembly to the second rate of injected substance is modifiable.
[0110] In a seventeenth aspect, according to any one of aspects thirteen to sixteen, the guide assembly advances the needle assembly further into the lung of the subject.
[0111] In the 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, which includes a proximal end and a distal end, which are spaced a distance apart from each other and define at least one fluid path therebetween. The distal end includes one or more fluid outlets connected to the at least one fluid path. The applicator is fluidly connected to the proximal end of the needle assembly. The applicator includes a first body, which includes a first biasing assembly connected to the needle assembly. The first body biases the needle assembly in a proximal direction relative to the applicator. The second body includes a syringe chamber and a syringe plunger, the syringe chamber having a needle connector port connected to the needle assembly fluid at its proximal end, the syringe plunger being arranged in the syringe chamber at the distal end of the syringe chamber and movable in the syringe chamber. The 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.
[0112] In a nineteenth aspect, according to aspect eighteen, when a force is applied to the proximal end of the syringe chamber in a distal direction, the force simultaneously overcomes the biasing forces of the first biasing assembly and the second biasing assembly, thereby moving the syringe plunger in a proximal direction relative to the syringe chamber and moving the needle assembly distally away from the first body in a distal direction opposite to the proximal direction.
[0113] In a twentieth aspect, according to the eighteenth or nineteenth aspect, the needle assembly further comprises a connector hub removably coupled to the needle connector port, wherein the elongated needle extends from the second body through the first body.
[0114] A twenty-first aspect, according to any one of aspects 18 to 20, comprises a pair of finger grip projections extending laterally from the first body.
[0115] A twenty-second aspect, according to any one of aspects eighteen to twenty-first, comprises a guide assembly for setting the advancement depth of the elongated needle.
[0116] In the twenty-third aspect, according to any one of aspects from the eighteenth to the twenty-second aspect, it also includes a guide assembly, which includes: a depth adjustment component, the depth adjustment component includes a threaded shaft, the threaded shaft includes: an axis head, the axis head having a first axis surface and a second axis surface opposite to the first axis surface, the first axis surface is in contact with the component delivery system; a collar, which has an internal threaded portion threadedly engaged to the threaded shaft in a locking setting and a groove allowing the threaded shaft to translate along the central axis of the guide assembly in an adjustment setting, an axis platform in contact with the second axis surface of the axis head; and an arched platform connected to the axis platform; a base; and an angle adjustment component, which has: a first guide member, the first guide member having a first end connected to the base, a second end connected to the base, and a first middle portion between the first end and the second end, the first middle portion being arranged at a distance from the base and contacting the arched platform; and a second guide member, which has a first end connected to the base, a second end connected to the base, and a second middle portion between the first end of the second guide member and the second end of the second guide member, the second middle portion being arranged at a distance from the base and contacting the axis platform.
[0117] In a twenty-fourth aspect, according to the twenty-third aspect, the threaded shaft is movable along the central axis when adjusting the setting.
[0118] In a twenty-fifth aspect, according to the twenty-third aspect, the depth adjustment component is movably coupled to the first guide member along a first rotation axis, wherein the second guide member is movably coupled along a second rotation axis perpendicular to the first rotation axis.
[0119] In a twenty-sixth aspect, according to any one of aspects twenty-third to twenty-fifth, the threaded shaft further comprises a threaded portion defining an outer diameter, and the groove defines an inner diameter that is larger in size than the outer diameter.
[0120] In a twenty-seventh aspect, according to any one of aspects twenty-third to twenty-sixth aspects, the elongated needle is disposed at a shaft outlet of the threaded shaft.
[0121] In a twenty-eighth aspect, according to any one of aspects twenty-third to twenty-sixth, 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.
[0122] In a twenty-ninth aspect, according to any one of aspects twenty-third to twenty-eighth, 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.
[0123] In a thirtieth aspect, according to any one of aspects twenty-third to twenty-ninth, the first middle portion and the second middle portion are provided between a surface of the shaft platform and a surface of the arched platform.
[0124] In the thirty-first aspect, according to any one of aspects from aspect 23 to aspect 30, the base also includes a first side and a second side diametrically opposite to the first side; a third side and a fourth side diametrically opposite to the third side; 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; and the fourth side is connected to the second end of the second guide member.
[0125] In a thirty-second aspect, a device includes a needle assembly, for which a trajectory is set through the pleural space toward a target at a known distance and the trajectory is maintained while the needle assembly is advanced. The needle assembly is advanced through the pleural space to the known distance at a first rate. A force is applied to a proximal end of the needle assembly in a distal direction, wherein the force simultaneously injects a substance at a second rate.
[0126] For the purposes of describing and defining the present disclosure, it is noted that the term "substantially" is utilized herein to represent the inherent degree of uncertainty attributable to any quantitative comparison, value, measurement, or other representation. The term "substantially" is also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. As such, it is utilized to represent the inherent degree of uncertainty attributable to any quantitative comparison, value, measurement, or other representation, and refers to an arrangement of elements or features that, while in theory expected to exhibit exact correspondence or behavior, may in practice manifest something slightly imprecise.
[0127] Although specific embodiments have been illustrated and described herein, it will be appreciated that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. In addition, although various aspects of the claimed subject matter have been described herein, these aspects need not be used in combination. Therefore, the appended claims are intended to cover all such changes and modifications within the scope of the claimed subject matter.
Claims
1. A medical sealant applicator device for delivering a multi-component sealant, characterized in that The medical sealant applicator device comprises: a first body having a base, a first syringe plunger, a second syringe plunger, and a longitudinal passage disposed transversely between the first syringe plunger and the second syringe plunger, wherein each of the first syringe plunger and the second syringe plunger is oriented to extend from the base in a first direction, 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; a second body having a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber disposed transversely 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 connected in fluid communication with each of the first syringe chamber and the second syringe chamber, the distal end of the longitudinal fluid chamber having a distal needle connector port, wherein: The first syringe chamber of the second body has a first distal opening to slidably receive 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 to slidably receive a 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 translatable within the longitudinal passage of the first body in response to longitudinal translation of the second body relative to the first body.
2. The medical sealant applicator device of claim 1, wherein: When 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 forces of the first biasing component of the first body and the second biasing component of the medical sealant applicator device, thereby causing the first syringe plunger and the second syringe plunger to move in the proximal direction relative to the first syringe barrel and the second syringe barrel, and the slender needle to move distally away from the base in the distal direction opposite to the proximal direction.
3. The medical sealant applicator device of claim 1, wherein: The base of the first body includes a distal aperture, wherein the longitudinal passage extends from the distal aperture in a first direction, and wherein 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 being removably coupled to a distal needle connector port of the second body, wherein the elongated needle extends from the second body through the distal aperture of the base of the first body.
4. The medical sealant applicator device according to any one of claims 1 to 3, characterized in that The second entity includes: a first u-shaped connector connecting the proximal end of the longitudinal fluid chamber in fluid communication with the first syringe chamber; and A second u-shaped connector connects the proximal end of the longitudinal fluid chamber in fluid communication with the second syringe chamber.
5. The medical sealant applicator device according to any one of claims 1 to 3, characterized in that The medical sealant applicator device includes a pair of finger grip projections extending laterally from a base of the first body.
6. The medical sealant applicator device according to any one of claims 1 to 3, characterized in that The medical sealant applicator device includes a guide assembly for setting an advancement depth of the elongated needle.
7. A medical sealant applicator device for delivering a multi-component sealant, characterized in that The medical sealant applicator device comprises: a first body having a base, a first syringe plunger, a second syringe plunger, and a longitudinal passage disposed transversely between the first syringe plunger and the second syringe plunger, wherein each of the first syringe plunger and the second syringe plunger is oriented to extend from the base in a first direction, 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; a second body having a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber disposed transversely 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 connected in fluid communication with each of the first syringe chamber and the second syringe chamber, the distal end of the longitudinal fluid chamber having a distal needle connector port, wherein: The first syringe chamber of the second body has a first distal opening to slidably receive 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 to slidably receive a 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 translatable within the longitudinal channel of the first body in response to longitudinal translation of the second body relative to the first body; and wherein the medical sealant applicator device further comprises: A guide assembly is used to set a trajectory toward a target location and maintain that trajectory while advancing the needle assembly and injecting the components.
8. The medical sealant applicator device of claim 7, wherein: When 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 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 in the proximal direction relative to the first syringe barrel and the second syringe plunger, and the slender needle moves distally away from the base in the distal direction opposite to the proximal direction.
9. The medical sealant applicator device of claim 7, wherein: The base of the first body includes a distal aperture, wherein the longitudinal passage extends from the distal aperture in a first direction, and wherein 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 being removably coupled to a distal needle connector port of the second body, wherein the elongated needle extends from the second body through the distal aperture of the base of the first body.
10. The medical sealant applicator device according to any one of claims 7 to 8, characterized in that The second entity includes: a first u-shaped connector connecting the proximal end of the longitudinal fluid chamber in fluid communication with the first syringe chamber; and A second u-shaped connector connects the proximal end of the longitudinal fluid chamber in fluid communication with a second syringe chamber.
11. The medical sealant applicator device according to any one of claims 7 to 9, characterized in that The medical sealant applicator device includes a pair of finger grip projections extending laterally from a base of the first body.
12. The medical sealant applicator device according to any one of claims 7 to 9, characterized in that The guide assembly sets the advancement depth of the elongated needle.
13. A method, characterized in that The method comprises: setting a trajectory of the needle assembly through the pleural space toward a target at a known distance and maintaining the trajectory while advancing the needle assembly; advancing the needle assembly through the pleural space to the known distance at a first rate; and A force is applied in a distal direction to the proximal end of the needle assembly, wherein the force simultaneously injects the substance at a second rate.
14. The method according to claim 13, characterized in that The advancement of the needle assembly is performed simultaneously with the application of force.
15. The method according to claim 13 or 14, characterized in that The first rate of the needle assembly is related to a second rate of injecting the substance.
16. The method according to claim 15, characterized in that The correlation of the first rate of the needle assembly to the second rate of injecting the substance is modifiable.
17. The method according to any one of claims 13 to 16, characterized in that The introducer assembly advances the needle assembly further into the subject's lung.
18. A component delivery system, characterized in that: The component delivery system comprises: a needle assembly having an elongated needle including a proximal end and a distal end, the proximal end and the distal end being spaced a distance from each other and defining at least one fluid path therebetween, the distal end including one or more fluid outlets coupled to the at least one fluid path; and an applicator fluidly coupled 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 in a proximal direction relative to the applicator, The second subject includes: a syringe chamber having a needle connector port on a proximal end thereof, the needle connector port being fluidly coupled to the needle assembly, and a syringe plunger disposed within the syringe chamber at a distal end of the syringe chamber and movable within the syringe chamber, and 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.
19. The component delivery system according to claim 18, characterized in that 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 in the proximal direction relative to the syringe chamber and causing the needle assembly to move distally away from the first body in the distal direction opposite to the proximal direction.
20. A component delivery system according to any one of claims 18 to 19, characterized in that The needle assembly also includes a connector hub removably coupled to the needle connector port, wherein the elongated needle extends from the second body through the first body.
21. A component delivery system according to any one of claims 18 to 20, characterized in that The component delivery system includes a pair of finger grip projections extending laterally from the first body.
22. A component delivery system according to any one of claims 18 to 20, characterized in that The component delivery system includes a guide assembly for setting an advancement depth of the elongated needle.
23. The component delivery system of claim 18, wherein: The component delivery system further includes a guide assembly, the guide assembly comprising: Depth adjustment components, including: a threaded shaft including a shaft head having a first shaft surface and a second shaft surface opposite the first shaft surface, the first shaft surface being in contact with the component delivery system; a collar including an internally threaded portion threadably engaged to the threaded shaft in a locking setting and a groove allowing translation of the threaded shaft along a central axis of the guide assembly in an adjustment setting; a shaft platform in contact with the second shaft surface of the shaft head; and an arched platform coupled to the shaft platform; Base; and Angle adjustment components, including: a first guide member having a first end coupled 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 being disposed a distance from the base and contacting the arcuate platform; and A second guide member has 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.
24. The component delivery system according to claim 23, characterized in that In an adjustment setting, the threaded shaft is movable along the central axis.
25. The component delivery system of claim 23, wherein: The depth adjustment component is movably coupled to the first guide member along a first rotational axis, wherein the second guide member is movably coupled along a second rotational axis perpendicular to the first rotational axis.
26. The component delivery system of claim 23, wherein: The threaded shaft also includes a threaded portion defining an outer diameter, and The slot defines an inner diameter that is larger in size than the outer diameter.
27. The component delivery system of claim 23, wherein: The elongated needle is disposed in a shaft outlet of the threaded shaft.
28. The component delivery system of claim 23, wherein: The first and second ends are rotatably coupled to the base to facilitate rotation of the first guide member relative to the base.
29. 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 to facilitate rotation of the second guide member relative to the base.
30. 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 arched platform.
31. The component delivery system of claim 23, wherein: The base also includes: a first side and a second side diametrically opposite the first side; a third side and a fourth side diametrically opposite the third side; 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; and The fourth side is coupled to the second end of the second guide member.
32. A device, characterized in that: The device comprises: a needle assembly for which a trajectory is set through the pleural space toward a target at a known distance, wherein the trajectory is maintained while advancing the needle assembly, wherein the needle assembly is advanced through the pleural space to the known distance at a first rate; and Therein, 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.
