Method and apparatus for treating tension pneumothorax using a rapidly deployable chest port

Abstract

To provide a method and apparatus for accessing a patient's pleural cavity using a rapidly deployable chest port. [Solution] This disclosure provides an apparatus and method for treating tension pneumothorax by using a rapid-deployment chest port. The rapid-deployment chest port can penetrate the patient's body to access the painful pleural cavity. The rapid-deployment chest port creates an airtight seal between the inside and outside of the patient's body and, when expanded, allows air or fluid to flow in one direction from inside to outside the body.

Description

Technical Field

[0001] Cross - Reference to Related Applications This patent application claims priority to U.S. Patent Application No. 62 / 773,765, titled "Methods and Apparatus for Treating Tension Pneumothorax Using a Rapid Deployment Chest Port," filed on November 30, 2018, under 35 U.S.C. § 119(e), the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure relates to methods and apparatus for treating tension pneumothorax.

Background Art

[0003] Tension pneumothorax is a condition where air progressively accumulates in the pleural cavity. Usually, air leaks into the pleural cavity due to a laceration of the lung and does not return. In effect, this forms a one - way valve through which air or fluid escapes from the lung.

[0004] As pressure gradually accumulates in the pleural cavity, the mediastinum is pushed into the opposite hemithorax, interfering with venous return to the heart. This can lead to circulatory instability and potentially to traumatic arrest.

[0005] Currently, the most effective treatment for tension pneumothorax is chest tube insertion. When a chest tube is inserted into the pleural cavity, usually by blunt dissection, the tension is relieved. However, this can take time that the patient may not have, and there is a risk of complications such as the need to suture the chest tube to the patient to reduce tube movement, creating inconsistent incision sizes that can lead to infection, and the need for suturing.

Summary of the Invention

Problems to be Solved by the Invention

[0006] Therefore, the present invention provides a method and apparatus for accessing a patient's pleural cavity using a rapid deployment chest port.

[0007] In one embodiment, the rapid deployment chest port includes a frame, a plunger having a blade at its distal end, the plunger being contained within the lumen of the frame, and a stabilizing component configured to stabilize the frame inside and outside the patient's thoracic cavity.

[0008] In another embodiment, the stabilization component includes an internal expansion flange attached to the outer diameter of the frame and an insertion stabilization platform attached to the outer diameter of the frame proximal to the internal expansion flange.

[0009] This specification also provides a method for removing air or fluid contained within the pleural cavity of a mammalian patient. In one embodiment, the method may include inserting the distal portion of the plunger blade and frame of a rapid deployment chest port into the patient's pleural cavity and expanding a stabilizing component so as to expand at least inside the patient's pleural cavity.

[0010] In another embodiment, the stabilization component includes an internal expansion flange attached to the outer diameter of the frame and an insertion stabilization platform attached to the outer diameter of the frame proximal to the internal expansion flange, and this method includes expanding the internal expansion flange.

[0011] Additional aspects and features are partially described below and may become apparent to those skilled in the art through examination of the specification or through practice of the disclosed subject matter. A further understanding of the nature and merits of the disclosure may be achieved by referring to the remainder of the specification and the drawings that form part of this disclosure.

[0012] The accompanying drawings, incorporated and comprising portions of this specification, illustrate several embodiments of the disclosure and, together with a detailed description, are useful in illustrating the principles of this disclosure. [Brief explanation of the drawing]

[0013] [Figure 1] Figure 1 shows an exemplary and modified example of a rapidly deployable chest port in a retracted state. [Figure 2] Figure 2 shows an exemplary variation of a rapidly deployable chest port in an extended state. [Figure 3] Figure 3 shows an exemplary variation of a method for using a rapid deployment chest port. [Figure 4] Figure 4 shows an alternative diagram of an exemplary modification of a rapid deployment chest port. [Figure 5] Figure 5 shows additional alternative diagrams of exemplary modifications of a rapid deployment chest port. [Figure 6] Figure 6 shows additional alternative diagrams of exemplary modifications of a rapid deployment chest port. [Figure 7] Figure 7 shows further alternative diagrams of exemplary modifications of the rapid deployment chest port. [Figure 8A] Figure 8A shows an exemplary modification of the distal end of a rapid deployment chest port. [Figure 8B] Figure 8B shows an exemplary modification of the distal end of a rapid deployment chest port. [Figure 9A] Figure 9A shows an exemplary variant of an insertion stabilization platform with fixed flexure. [Figure 9B] Figure 9B shows the distal end of a rapid deployment chest port with an exemplary variant of an insertion stabilization platform having fixed flexure. [Figure 10A] Figure 10A shows an exemplary variation of a compression fitting base insertion stabilization platform. [Figure 10B] Figure 10B shows an exemplary variation of a compression fitting-based insertion stabilization platform. [Figure 12] Figure 12 shows further alternative diagrams of exemplary modifications of a rapid deployment chest port. [Figure 13] Figure 13 shows an exemplary modification of the distal end of a rapid deployment chest port. [Figure 14] Figure 14 shows an exemplary and modified example of a method for treating tension pneumothorax using a rapidly deployable chest port.

Best Mode for Carrying Out the Invention

[0014] In the following sections, detailed descriptions of the embodiments and methods of the present disclosure are presented. The descriptions of both preferred examples and alternative examples are merely illustrative, and it is understood by those skilled in the art that variations, modifications, and alterations may be apparent. Therefore, it should be understood that these embodiments do not limit the scope of the underlying disclosure defined by the claims.

[0015] In this detailed description, "distal" means the end extending into the body, and "proximal" means the end extending from the body.

[0016] In this detailed description, "connected (to)" includes two components that are either directly connected or indirectly connected through intervening components.

[0017] The terms used herein generally have their ordinary meanings in the art, within the context of the disclosure, and in the particular context in which each term is used. Alternative languages and synonyms may be used for any one or more of the terms discussed herein, and there is no special significance whether the term is refined or discussed herein. In some cases, synonyms for a term are provided. Looking backward at one or more synonyms does not exclude the use of other synonyms. The use of any example of any term discussed herein is merely illustrative and is not intended to further limit the scope and meaning of the disclosure or the term example.

[0018] This disclosure generally provides a method and apparatus for treating tension pneumothorax using a rapid deployment chest port. According to this disclosure, the rapid deployment chest port is inserted into the pleural region of the patient's body using a sharp surface such as a blade, needle, sharp tip, or knife edge. The sharp surface can be attached to the rapid deployment chest port. After insertion, the rapid deployment chest port can be expanded to open the pleural cavity and relieve pressure due to the accumulation of air and / or fluid in the pleural cavity. In some modifications, the rapid deployment chest port may further use suction to remove fluid from the pleural cavity.

[0019] Rapid deployment chest ports allow for rapid and standardized insertion of a chest tube, eliminating the need to create a scalpel incision before insertion, similar to current medical practices. Scalpel incisions can lead to inconsistent incisions that may be too large for the chest port, resulting in an open wound around the port that may require suturing. Therefore, rapid deployment chest ports reduce the risk of infection in the patient because they create a standardized incision that is precisely sized for the port. Furthermore, standard chest ports require suturing to stabilize them and prevent movement within the patient. This requires additional time for the placement of the chest tube before the patient can be treated. Performing incision and suturing separately can mean that a standard chest tube can be inserted and ready for use in several minutes. Rapid deployment chest ports do not require a separate incision or additional suturing, reducing the time required to insert the chest port and begin treating the patient. In some modifications, rapid deployment chest ports can be deployed in under 20 seconds. In some modifications, rapid deployment chest ports may be deployed in under 30 seconds. In some modifications, the rapid deployment chest port may deploy within 60 seconds. In some modifications, the rapid deployment chest port may deploy within 90 seconds.

[0020] Referring to Figure 1, an exemplary variation of the rapid deployment chest port 100 in a retracted state is shown. The rapid deployment chest port 100 may include one or more blades 102, a frame 104, one or more internal expansion flanges 106, a check valve 108, an internal expansion mechanism 110, one or more external expansion flanges 120, and / or a dial mechanism 122. In some variations, the blade 102 includes a sharp projection on the underside of the rapid deployment chest port 100. The blade 102 includes a sharp surface, and non-limiting examples of blades include knives, needles, scalpels, double-bladed scalpels, or other objects with a surface sharp enough to penetrate the chest and enter the pleural cavity. In exemplary variations, the blade 102 is sharpened to allow a desired blunt incision with minimal effect on the outside of the patient's body. In some variations, the blade 102 may be blunt, such as cone-shaped, as seen in Figures 7 and 12. In some modifications, as seen in Figure 12, the blade 102 can be angled or curved like the tip of a fountain pen to guide the blade naturally over the intended rib. The blade can be realized with or without an internal lumen. In modifications including a lumen, the lumen is used in combination with a syringe or other airtight device to create a vacuum while the device advances through the patient's tissue. For example, the blade can be fluidly connected to the frame and / or handle. The blade is attached to the distal end of the rapid deployment chest port so that it can penetrate the patient and reach the pleural cavity without requiring a separate scalpel. This allows for a more precise incision sized to match the rapid deployment chest port without creating an unnecessarily wide opening, which is common when using a scalpel.

[0021] The blade 102 may be connected to or connectable to the frame 104. The frame 104 may be made of a suitable material such as plastic or steel. In other modifications, the frame 104 may be substantially cylindrical. In additional examples, the frame may further include a peel-away introducer at its distal end. In some specific examples, the frame 104 is pentagonal in shape, with one or more attachments extending from the points of the pentagon. Other shapes are within the scope of the present invention. Non-limiting examples of these one or more attachments are shown as frame attachments 104A and 104B in Example 1 of Figure 1. In such modifications, the blade 102 may be attached to only one of these frame attachments. As a non-limiting example, Figure 1 shows the blade 102 attached to the right frame attachment 104B, but the blade 102 may also be attached to the left frame attachment 104A. The frame 104 is surrounded at the bottom by the blades 102 on each side by an internal expansion mechanism 110, and can house the check valve 108 inside. One or more internal expansion flanges 106 can also be attached to the frame 104 at points near the blades 102. Further modifications may include blades that are appropriately sized and shaped to accept the frame after insertion.

[0022] The internal expansion flange 106 is connected to the frame 104 near the blade 102. In some modifications, the internal expansion flange 106 may additionally include a sleeve such as a mesh net. In other modifications, the internal expansion flange 106 includes a balloon. The balloon expands within the pleural cavity, securing the rapid deployment chest port in the correct position. In some modifications, the internal expansion flange 106 is made of a material rigid enough to allow force to be applied to open a larger area within the pleural cavity. Similarly, the external expansion flange 120 may be made of the same rigid material. In other modifications, the internal and external expansion flanges may be made of highly compliant materials so that they conform to the body and can be operated in a way that minimizes injury to the body. The external expansion flange 120 is located at the end of the rapid deployment chest port 100 opposite the blade 102. The external expansion flange helps to prevent the rapid deployment chest port from moving downward into the patient and, in some modifications, is placed on the patient's body during insertion of the rapid deployment chest port 100. In some modifications, the external expansion flange 120 does not expand even when the dial mechanism 122 is engaged. One or both of the internal expansion flange 106 and the external expansion flange 120 can serve to secure the rapid deployment chest port 100 placed on the patient's body. As shown in Figure 4, in some modifications, the external expansion flange 120 may be in the form of a disc or plate. In some modifications, the external expansion flange may be slidable along the length of the frame. In at least some modifications, the external expansion flange can be fixed or secured once placed on the patient's body. In some modifications, the plate may be covered with a pad. In other modifications, one or both of the internal expansion flange 106 and the external expansion flange 120 may include a stationary (fixed) balloon, an adjustable balloon (whose adjustment can be achieved using the dial mechanism 122 or a syringe through the external valve port), a stationary pad, or an adjustable pad. The internal and external expansion flanges can be used in combination on either side of the incision to secure the rapid deployment chest port to the patient in the appropriate position.

[0023] The internal expansion mechanism 110 may extend throughout the entire frame 104. The internal expansion mechanism 110 connects a dial mechanism 122, which may be located above the rapid deployment chest port 100, to the internal and external expansion flanges 106 and 120, respectively. In a non-limiting example, the internal expansion mechanism may include one or more of a spring, a chemical reaction, or a wheel. The dial mechanism 122 controls the expansion and contraction of the internal expansion mechanism 110. In exemplary variations, the dial mechanism includes a rotating element. However, any means for engaging, expanding, and contracting the internal expansion mechanism 110 is intended herein. In a non-limiting example of a variation of the non-rotating dial mechanism, the dial mechanism may include a plunger, a button, a toggle, a slide ratchet mechanism, or a digital controller that can interact with the user by one or more of Bluetooth®, NFC, Wi-Fi, 3G, LTE, or a touchscreen. The dial mechanism may include a finite number of predetermined settings using a plurality of stops or pawls, or it may be continuously adjustable. The dial mechanism 122 can help secure the rapid deployment chest port 100 in the appropriate position.

[0024] Referring to Figure 2, the extended position of the rapid deployment chest port 100 is shown. In some modifications, when rotated, the dial mechanism 122 extends the expansion flanges 106 and 120 via the internal expansion mechanism 110. In some modifications, the dial mechanism 122 can be locked in place once the desired expansion setting is reached. In a modification in which the frame 104 consists of frame attachments 104A and 104B, when the rapid deployment chest port 100 is in the extended state, the frame attachments 104A and 104B are pulled together with the blade 102.

[0025] When inserted, the rapid deployment chest port 100 can create an airtight seal between the pleural cavity and the outside of the patient's body. In some modifications, the external expansion flange 120 includes a flexible material that molds to the shape of the patient's body. When expanded, air or fluid can only escape through the air vent opening 200. The air vent opening 200 horizontally divides the frame 104, allowing trapped air to escape from the patient's rib cage. In an exemplary modification, when the rapid deployment chest port 100 is in the expanded state, an embedded check valve 108 is exposed. The check valve 108 may function as a one-way valve for air moving throughout the air vent opening 200. The check valve 108 ensures that air trapped within the rib cage is expelled from the patient's body through the air vent opening 200, while preventing additional air from entering. In other modifications, the check valve 108 allows fluid trapped in the pleural cavity to be removed through the air relief opening 200 or a lumen within the frame and expelled from the patient's body. For example, if the pressure in the pleural cavity increases, air or fluid may move within the frame without the use of a suction source. In other examples, the check valve may be connected to a suction source to further assist in the removal of air or fluid. In some modifications, the check valve 108 comprises a passive, flexible, one-way valve such as a Heimlich valve. In some modifications, the check valve 108 may be located outside the rapid deployment chest port, as shown in Figure 6. In some modifications, two or more check valves 108 can be used. These check valves 108 may be embedded inside, inside, or outside the rapid deployment chest port 100.

[0026] In some variations, the universal suction tube adapter 204 can be attached to the proximal end of the air relief opening 200. The universal suction tube adapter 204 can be adjusted to various industry standard sizes, such as 8 French, 16 French, 20 French, 24 French, 28 French, 36 French, and 40 French, depending on the situation and the need for available chest tubes. In some variations, the universal suction tube adapter may include male or female Luer connectors. Thus, a physician or other healthcare professional can supply a chest tube into the patient's pleural cavity and continue the safe removal of trapped air or fluid in accordance with current medical treatment for tension pneumothorax.

[0027] In some modifications, when the rapid deployment chest port 100 is in an expanded state, the blade 102 can be retracted into the frame 104 in a blade retraction slot 202. The blade retraction slot 202 may be any means to ensure that the point of the blade 102 is not exposed inside the patient's body after retraction. In some modifications, the blade retraction slot 202 may include means for wiping the tip of the blade 102. Such means may include, for example, a narrow opening or an absorbent membrane. In some modifications, the blade 102 is connected to a dial mechanism 122, and therefore retraction occurs by engagement of the dial mechanism 122. For example, if the dial mechanism 122 has a dial with a predetermined stop, the blade 102 can be slowly retracted as the dial mechanism 122 is turned. In other modifications, such as when the dial mechanism 122 includes a plunger or other binary engagement mechanism, the blade 102 may be retracted instantaneously upon engagement with the dial mechanism 122.

[0028] In some variations, such as the variation in which the dial mechanism 122 is a plunger, activation of the dial mechanism 122 may trigger several simultaneous reactions in the rapid deployment chest port 100. In a non-limiting example, activating the plunger may cause one or more of the following: extending the blade from the distal end of the frame, extending the external expansion flange 120, extending the internal expansion flange 106, retracting the blade 102 into the blade retraction slot 202, or deploying the sleeve from the internal expansion flange 106.

[0029] Referring to Figure 3, an exemplary variation of a method for using a rapid deployment chest port, such as for treating tension pneumothorax 300, is shown. In any step 301, preliminary steps are taken to prepare for the insertion of the rapid deployment chest port 100. These steps may include adjusting the length of the frame 104, using the internal expansion mechanism 110 to ensure an appropriate insertion depth, or preparing the patient's body. In the exemplary variation, the insertion depth is a function of the distance between the blade 102 that guides the insertion into the patient's body and the external expansion flange 120 that stops the insertion when it comes into contact with the patient's body. Furthermore, in some patients, insertion that is too shallow may be ineffective, and insertion that is too deep may be lethal. Thus, this preliminary calibration is important. In some variations, the method may further include using a syringe connected to a plunger to aspirate a small amount from the pleural cavity to ensure that the rapid deployment chest port is inserted to the correct depth. This method may include further adjustment of the depth of the rapid deployment chest port if necessary. Other preliminary steps, such as disinfecting the blade, may be required in some variations or situations. However, in the exemplary variations, the rapid deployment chest port 100 is stored in sterile, self-contained packaging designed for rapid deployment, and the rapid deployment chest port itself may be coated with one or more disinfectants, antiseptics, or anesthetics. Thus, in the exemplary variations, any step 301, if present, is minimal.

[0030] In step 302, the rapid deployment chest port 100 is inserted into the patient's body. Due to the durability of the pleural cavity, considerable force may be required for this insertion. In some modifications, it may be desirable to access the pleural cavity indirectly, such as through the patient's axilla. In the exemplary modification, insertion is completed when the external expansion flange 120 is in contact with the patient's body.

[0031] In step 303, the dial mechanism 122 is engaged. In some modifications, when the rapid deployment chest port 100 is in the expanded state, a sleeve around the internal expansion flange 106 expands. In other modifications, the internal expansion flange is a balloon that is filled with air and expands. In some modifications, such as when the dial mechanism 122 includes a dial with a predetermined stop, one or more of the following expansion / contraction steps may occur gradually: (a) expanding or sliding the external expansion flange 120; (b) expanding the internal expansion flange 106; (c) contracting the blade 102 into the blade retraction slot 202 or into the frame lumen. In other modifications, such as binary engagement or instant engagement variations, such as when the dial mechanism 122 includes a plunger, the aforementioned expansion / contraction steps may occur instantly or with minimal delay or discontinuity. In any case, at the end of step 302, the rapid deployment chest port 100 is at least partially expanded.

[0032] In any step 304, air or fluid can be expelled through the air relief opening 200 via a universal suction tube adapter 204, in one modification. The chest tube allows the treatment of tension pneumothorax to proceed according to current and known methods. In some examples, the plunger can be removed and a check valve can be connected to a one-way valve at the proximal end of the frame via a Luer connector. In this example, a stepped connector connected to the proximal end of the check valve can be connected to a suction source to remove air or fluid from the pleural cavity.

[0033] Finally, in step 305, the dial mechanism 122 is operated in the reverse direction to deflate the rapid deployment chest port 100. If the sleeve is deployed in step 303, it can enclose one or more of the internal expansion flange 106, the blade 102, the blade retraction port 202, the check valve 108, or the frame 102. If the internal expansion flange is a balloon, this method may further include deflating the balloon before removing the rapid deployment chest port. The rapid deployment chest port 100 can then be safely removed from the patient's body.

[0034] Referring to Figure 4, another diagram of an alternative modification of the rapid deployment chest port 100 is shown. In particular, in this modification, the blade 102 is stretched across the entire frame, so the frame attachments 104A and 104B are absent. Instead, when the dial mechanism 122 is engaged (actuated), the blade 102 retracts and one or more of the expansion flanges expand, but the frame may not deform. Figure 4 also shows a modification in which the dial mechanism 122 includes a plunger, and the internal expansion flange 106 deploys the sleeve 401 when the plunger is pressed. In this exemplary, non-limiting modification, the external expansion flange 120 is already at its expanded size before the dial mechanism 122 is engaged.

[0035] Next, referring to Figure 5, an angular view (perspective view) of an alternative modification of Figure 4 is shown.

[0036] Next, referring to Figure 6, another alternative modification is shown. In this modification, the dial mechanism 122 includes a plunger. It will be recognized by those skilled in the art that the plunger may be independent of the dial mechanism. In some modifications, the dial mechanism 122 and the external expansion flange 120 can then perform the same function. In some modifications, a finger grip 620 may be present to assist the user in guiding the rapid deployment chest port 100 to a desired spot. In some modifications, the plunger structure may be removable from the frame 104. The plunger can be inserted into the frame 104 via a plunger port 622. In some modifications, the plunger port 622 includes a groove. In some modifications, an external valve port 610 may be supplied to the frame 104. As described above, the external valve port 610 can be operated to allow the check valve to be inserted into the frame 104, without the check valve needing to be integrated into the rapid deployment chest port 100.

[0037] In addition, the internal expansion flange 106 may have one or more grooves or protrusions 602 for securing the frame 104 to the insertion stabilization platform 606. The insertion stabilization platform 606 may be integrated into the rapid deployment chest port 100, into which the frame 104 and blade 102 may be inserted. The insertion stabilization platform 606 can help secure the rapid deployment chest port in the correct position. The insertion stabilization platform 606 includes a balloon or pad, which may be fixed or adjustable. In some variations, the insertion stabilization platform 606 is adjustable by the protrusions 602. In some variations, the protrusions 602 may include a sliding-ratchet mechanism. In some variations, the insertion stabilization platform may have a coating of an anesthetic or disinfectant compound.

[0038] In some variations, the rapid deployment chest port 100 may be modular, as shown in the figure. In a non-limiting example, the rapid deployment chest port 100 may include three separate pieces, a dial mechanism 122 (including a finger grip 620 and a shaft connecting the dial mechanism 122 to the blade 102), a frame 104 (including an external valve port 610 and, in some variations, a protrusion 602, as shown in the figure), and an optional insertion stabilization platform 606. In some variations, the blade 102 may already be fixed to the frame 104 or the insertion stabilization platform 606 stylet.

[0039] Next, with reference to Figures 7, 8A, and 8B, another alternative modification is shown. In some modifications, the rapid deployment chest port 700 may be modular, as illustrated. In a non-limiting example, the rapid deployment chest port 700 may include a plunger 704 connecting a handle 702 (e.g., a finger grip) to a blade 102, a frame 104 (including the plunger 704 and a lumen for air and / or fluid, a Y-hub with an external valve port 610, and in some modifications, a plunger port 622 having a Luer connector at its proximal end), and stabilization components. In some modifications, the stabilization components may include an internal expansion flange 106 (including a balloon in this example) and an external expansion flange (including an insertion stabilization platform 606 in this example). In modifications, the plunger 704 may be a stylet shaft extending the length of the frame. In some variants, the blade 102 may be fixed to the distal end of the frame 104 or the plunger.

[0040] In some modifications, the frame 104 may be compliant so as to be compressible. In additional modifications, the frame 104 may be a catheter such as a silicone catheter, or a plastic or rubber extruded material. In some modifications, the frame may include a lip to assist in the insertion of a rapid deployment chest port so as not to collapse during insertion. In other modifications, the frame may not include a lip if a peel-away introducer is used to reinforce the frame during insertion. Also, the use of an introducer may compress the outer diameter of the frame at the insertion site. Therefore, in some embodiments, the diameter of the frame may depend on the use of an introducer. In some modifications, the diameter of the frame may range from 5 French to 40 French. In some modifications, the diameter of the frame may be 5 French. In some modifications, the diameter of the frame may be 8 French. In some modifications, the diameter of the frame may be 10 French. In some modifications, the diameter of the frame may be 16 French. In some modifications, the diameter of the frame may be 20 French. In some modifications, the diameter of the frame may be 25 French. Depending on the modification, the frame diameter may be 30 French. Depending on the modification, the frame diameter may be 35 French. Depending on the modification, the frame diameter may be 40 French.

[0041] In this modification, the plunger 704 is connected to the blade 102 at its distal end and to a finger grip at its proximal end. In other modifications, the blade may be integrated with the plunger so as to be a single element. For example, the plunger may have a tapered distal end and form a blade. In other examples, the plunger may terminate with a blade. In some modifications, the blade 102 may be any structure capable of piercing the skin and penetrating through the body into the pleural cavity. Non-limiting examples of the blade include needles, sharp point edges, and / or knife edges. In at least one embodiment, the blade 102 may be a sharp silicone tip. In some modifications, the finger grip may be a handle 702. The handle 702 may have an upper and a lower section, with the lower section being longer than the upper section. In some modifications, the upper and lower sections may be angled to provide an ergonomic handle. In some modifications, the handle may be present to assist the user in guiding the rapid deployment chest port 700 to a desired spot. In a modified version, the handle may further be provided with a syringe port 720 at the proximal end of the handle. In one embodiment, an aspiration syringe 722 can be attached to the syringe port 720 to test the placement of the rapid deployment chest port 700. In this example, the user can withdraw the aspiration syringe 722 to identify the fluid or air located at the blade / distal end of the frame. If the rapid deployment chest port 700 is in the wrong position, the user can adjust the placement by moving the handle toward or away from the patient, as necessary. The placement of the rapid deployment chest port 700 may be tested again using the aspiration syringe. Once the correct placement of the rapid deployment chest port 700 is confirmed, the aspiration syringe 722 can be withdrawn from the syringe port 720 on the handle.

[0042] In some variations, the plunger structure may be removable from the frame 104. The plunger 704 can be inserted into the frame 104 through a plunger port 622 on the frame 104. In some variations, the plunger port 622 may be located on a Y-hub 718. The plunger 704 may pass through a lumen within the frame and terminate within the blade 102. In some variations, the plunger port 622 may include a Luer connector. In some variations, the handle may include a mutual Luer connector 706 for connecting the handle to the plunger port 622. The plunger 704 may be inserted and then removed. For example, when the rapid deployment chest port 700 is placed in the patient's pleural cavity, the plunger 704 can be removed from the frame 104. In some variations, once the plunger 704 is removed, a mutual Luer connector 708 may be connected to the plunger port 622 to attach the external check valve assembly to the frame 104. The external check valve assembly can be operated so that the check valve does not need to be incorporated into the rapid deployment chest port 700 and can be inserted into the frame 104. In some modifications, the check valve assembly may include a Luer connector 708, a check valve 712, a valve outlet tube 710 connected to the Luer connector and distal to the check valve, a valve inlet tube 714 proximal to the check valve, and a connector 716 to a suction source. In some modifications, the connector may include a stepped connector. The stepped connector can be attached to the suction source so that fluid and / or air trapped in the pleural cavity is drawn through the frame 104 to the suction source. In some modifications, when in use or not connected to the plunger port 622, the check valve assembly can be attached to the frame 104 by a strap 726 so that it is readily available when needed to connect to the plunger port 622.

[0043] The frame 104 may further include an external valve port 610 on the Y-hub 718. In some modifications, the external valve port 610 may be a Luer-operated valve. The Luer-operated valve may be connected to a lumen within the frame 104 and then to an internal expansion flange. In some embodiments, a syringe 724 may be connected to the Luer-operated valve to supply air to the internal expansion flange when the internal expansion flange is a balloon.

[0044] In some variations, the rapid deployment chest port includes a stabilization component configured to stabilize the frame inside and outside the patient's thoracic cavity. The stabilization component may be a single component configured to expand inside and outside the patient's thoracic cavity. In some variations, the single stabilization component is a balloon, as seen in Figure 8A. In some examples, the stabilization component includes an internal expansion flange attached to the outer diameter of the frame and an external expansion flange (or insertion stabilization platform) attached to the outer diameter of the frame proximal to the internal expansion flange.

[0045] In some variations, the external expansion flange is an insertion stabilization platform 606, as shown in Figure 7. The insertion stabilization platform 606 can help secure the rapid deployment chest port in the appropriate position. In some variations, the insertion stabilization platform may be a disk and may have a diameter sufficient to support and secure the rapid deployment chest port. In some variations, the insertion stabilization platform may have a diameter of 5 mm to 60 mm. In some variations, the insertion stabilization platform may have a diameter of at least 5 mm. In some variations, the insertion stabilization platform may have a diameter of at least 10 mm. In some variations, the insertion stabilization platform may have a diameter of at least 15 mm. In some variations, the insertion stabilization platform may have a diameter of at least 20 mm. In some variations, the insertion stabilization platform may have a diameter of at least 30 mm. In some variations, the insertion stabilization platform may have a diameter of at least 40 mm. In some variations, the insertion stabilization platform may have a diameter of at least 50 mm. In some variations, the diameter of the insertion stabilization platform may be less than 60 mm.

[0046] The insertion stabilization platform is positioned away from the blade and can provide an external surface to ensure the placement of the rapid deployment chest port 700. In some modifications, the insertion stabilization platform 606 may be placed on the patient when the rapid deployment chest port has been inserted to the appropriate distance. The position of the insertion stabilization platform may be adjustable. The insertion stabilization platform may initially be positioned away from the blade to reduce the risk of damage to internal structures during insertion of the rapid deployment chest port. In some modifications, the insertion stabilization platform can be positioned 3 cm to 7 cm from the blade. Since the pleural cavity of most patients is within 6.5 cm from the body surface, setting the initial distance of the insertion stabilization platform to 6.5 cm allows the chest port to rapidly deploy to the thickness of most patients, while limiting the insertion depth to prevent internal damage. In some modifications, the insertion stabilization platform 606 may not be adjustable beyond 7 cm from the blade 102.

[0047] In a modified example, the insertion stabilization platform 606 may have one or more gloves or protrusions 602, such as fixing bends, for securing the insertion stabilization platform 606 to the frame. The insertion stabilization platform 606 may be integrated into the rapid deployment chest port 700, or it may be a separate piece into which the frame 104 and blade 102 can be inserted.

[0048] In several modifications, as seen in Figures 9A, 9B, 10A, and 10B, the insertion stabilization platform 606 is adjustable by a fixed bend. In some examples, the insertion stabilization platform includes an opening 802 that allows the insertion stabilization platform to slide along the frame 104, and can then be fixed in position relative to the patient using a fixed bend after the rapid deployment chest port has been inserted to the appropriate distance. The fixed bend can have various lengths and shapes to facilitate gripping and sliding the insertion stabilization platform. The fixed bend may have two extensions, each having an outwardly extending flange, as seen in Figures 9A and 9B. In some examples, the two extensions and the outwardly extending flanges can be extended and curved, as seen in Figures 9A and 9B. In some modifications, the insertion stabilization platform can be fixed in place by sliding the insertion stabilization platform along the frame with the fixed bend in place and releasing the fixed bend. In other modifications, the projection may include a slide-ratchet mechanism for moving the insertion stabilization platform and fixing it to the frame. In additional modifications, the insertion stabilization platform 606 may form a seal around the frame to hold the insertion stabilization platform in place, limit the initial insertion depth, and prevent frame movement. For example, the insertion stabilization platform 606 may include a compression fitting, as shown in Figures 10A and 10B. In some modifications, the compression fitting may include a knob 1002, a compression sleeve 1004, a compression hub 1006, and / or a compression pad 1008, as shown in Figures 10A and 10B. In some examples, the insertion stabilization platform 606 may include a threaded connector between the knob 1002 and the compression hub 1006. When the knob 1002 is tightened onto the hub 1006, the compression sleeve 1004 is compressed against the frame 104, preventing relative movement. In some modifications, the insertion stabilization platform includes a balloon or pad facing the patient's surface, which may be stationary or adjustable.In some variations, the insertion stabilization platform may have a coating of an anesthetic or disinfectant compound.

[0049] In some modifications, the rapid deployment chest port may include an internal expansion flange 106 connected to the frame 104 near the blade 102. In some modifications, the internal expansion flange 106 may be a balloon, as seen in Figures 7 and 11A. In some modifications, the balloon is a compliance balloon. For example, the balloon may be a silicone balloon with a stiffness of Shore A 50 or less. In other modifications, the internal expansion flange may be any expandable structure made of a material suitable for generating a flexible element, such as nitinol. In at least one modification, the internal expansion flange 106 may be an expandable nitinol ascot or a silicone-coated expandable nitinol ascot, as seen in Figure 11B.

[0050] The diameter of the internal expansion flange can range from approximately 5 mm to 55 mm. In some non-limiting modifications, the internal expansion flange may have a diameter of at least 5 mm. In some non-limiting modifications, the internal expansion flange may have a diameter of at least 21 mm. In some non-limiting modifications, the internal expansion flange may have a diameter of at least 27 mm. In some non-limiting modifications, the internal expansion flange may have a diameter of at least 38 mm. In some non-limiting modifications, the internal expansion flange may have a diameter of at least 52 mm. In some non-limiting modifications, the diameter of the internal expansion flange may be 55 mm or less. In some non-limiting modifications, the internal expansion flange may have a diameter of 52 mm or less. In some non-limiting modifications, the internal expansion flange may have a diameter of 38 mm or less. In some non-limiting modifications, the internal expansion flange may have a diameter of 27 mm or less. In some non-limiting modifications, the internal expansion flange may have a diameter of 21 mm or less. In some non-limiting modifications, the internal expansion flange may have a diameter of 15 mm or less. In some non-limiting modifications, the internal expansion flange may have a diameter of 10 mm or less.

[0051] The diameter of the insertion stabilization platform is selected based on the diameter of the frame to limit patient injury during insertion and removal. Internal expansion may be large enough to provide sufficient force to prevent withdrawal or frame displacement during the course of normal events, but is desirable while reducing the possibility of the rapid deployment chest port damaging tissue and otherwise harming the patient if the frame is subjected to too much force. In at least some modifications, the ratio of the diameter of the insertion stabilization platform to the diameter of the frame can be in the range of 2.5 to 6. In one non-limiting modification, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame is at least 2.5. In one non-limiting modification, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame is at least 3.0. In one non-limiting modification, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame is at least 4.0. In one non-limiting modification, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame is at least 5.0. In one non-limiting modification, the ratio of the diameter of the insertion stabilization platform to the diameter of the frame is 6.0 or less. In one non-limiting modification, the ratio of the diameter of the insertion stabilization platform to the diameter of the frame is 5.0 or less. In one non-limiting modification, the ratio of the diameter of the insertion stabilization platform to the diameter of the frame is 4.0 or less. In one non-limiting modification, the ratio of the diameter of the insertion stabilization platform to the diameter of the frame is 3.0 or less. In at least one modification, the ratio of the diameter of the insertion stabilization platform to the diameter of the frame may be in the range of 3 to 5. For example, the ratio of the diameter of the insertion stabilization platform to the diameter of the frame may be 5.

[0052] In other non-limiting examples, the balloon may be made of urethane, Pebax, or any other thermoforming or extruded material. In variations, when used with a 16-French frame, the balloon volume may be between 2 mL and 10 mL. The balloon volume, and therefore the balloon diameter, can be adjusted based on the frame diameter based on the ratio of the internal expansion flange to the frame diameter. In variations, the balloon may have a volume of 2 mL. In variations, the balloon may have a volume of 3 mL. In variations, the balloon may have a volume of 4 mL. In variations, the balloon may have a volume of 5 mL. In variations, the balloon may have a volume of 6 mL. In variations, the balloon may have a volume of 7 mL. In variations, the balloon may have a volume of 8 mL. In variations, the balloon may have a volume of 9 mL. In variations, the balloon may have a volume of 10 mL.

[0053] The external valve port 610 may be fluidly connected to the stabilization component to expand and contract the internal expansion flange and / or insertion stabilization platform. In a variation, if the internal expansion flange is a balloon, the external valve port 610 may be fluidly connected to the internal expansion flange to facilitate the connection of a syringe for expanding and contracting the balloon with air. To assist in the insertion of the rapid deployment chest port, the internal expansion flange may be initially contracted against the outer diameter of the frame. Figures 12 and 13 show the internal expansion flange 106 contracted against the frame 104. If properly positioned, the internal expansion flange can expand in the pleural cavity to secure the rapid deployment chest port. Either or both of the internal expansion flange 106 and the insertion stabilization platform 606 can help secure the rapid deployment chest port 700 when it is positioned on the patient's body.

[0054] The balloon and insertion stabilization platform can be used in combination on both sides of the incision to secure the rapid deployment chest port in the correct position in the patient. In some variations, the combination of the insertion stabilization platform and the internal expansion flange allows the rapid deployment chest port to form an airtight seal between the inside and outside of the patient's body. This allows for efficient removal of air or fluid from the pleural cavity, potentially reducing the risk of infection at the insertion site and shortening the time required to treat the patient.

[0055] Next, referring to Figure 12, an alternative modification of the alternative modification of Figure 7 is shown. In this modification, the frame 104 may further include a peel-away introducer 1202 to assist in the insertion of the rapid deployment chest port 700, as further seen in Figure 13. In some modifications, the stabilizing component may include a compressed, expandable portion of the frame that is compressed during insertion and, after insertion, expands to the contours around the internal and external tissues of the insertion site to prevent frame movement following deployment. In at least one example, the frame is compressed by the peel-away introducer and then expands within the incision once the introducer is removed. The peel-away introducer 1202 includes a heat-shrinkable material that compresses the frame onto the plunger. At the distal end of the rapid deployment chest port, the heat shrinkage may allow for a smooth transition from the plunger to the frame. Furthermore, the peel-away introducer 1202 may include modeled finger grips used to peel off the two halves of the heat-shrinkable material. In some variations, these finger grips may also be used to limit the insertion depth. For example, the underside of the finger grip may be used to reduce the risk of damage to internal structures during insertion of a rapid deployment chest port by providing a stop at the insertion depth. In variations, the distal end of the finger grip may be located 3 cm to 7 cm from the blade. In this example, the position of the finger grip on the peel-away introducer may allow for rapid deployment of the chest port to limit the insertion depth to prevent internal damage while removing thickness for most patients. In variations, the finger grip on the peel-away introducer may not be located beyond 7 cm from the blade 102.

[0056] Referring to Figure 14, an exemplary variation of a method for accessing the pleural cavity of patient 1400 is shown. Access to the patient's pleural cavity may be required, whether urgent or non-urgent. Non-limited procedures or needs for accessing the pleural cavity include treating tension pneumothorax, treating non-tension pneumothorax, removing fluid from trauma, draining small amounts of fluid, and / or administering drugs to the pleural cavity. In any step 1402, preliminary steps are taken to prepare for insertion of the rapid deployment chest port. These steps may include adjusting the position of the insertion stabilization platform along the frame or preparing the patient's body. In the exemplary variation, the insertion depth is a function of the distance between the blades guiding the insertion into the patient's body, and the insertion stabilization platform stops the insertion when it becomes stationary in the patient's body. Furthermore, in some patients, insertion that is too shallow may be ineffective, and insertion that is too deep may cause excessive harm. Other preliminary steps, such as disinfecting the blades, may be required in some variations and situations. However, in the exemplary variant, the rapid deployment chest port is stored in a sterile, self-contained package designed for rapid deployment, and the rapid deployment chest port itself is coated with one or more of the disinfectants, antiseptics, or anesthetics. Thus, in the exemplary variant, any step 1402 is present only minimally, if any.

[0057] In step 1404, the rapid deployment chest port is inserted into the patient's body. In some variations, this may involve inserting the plunger blade and the distal portion of the frame of the rapid deployment chest port into the patient's pleural cavity. Due to the tolerance of the pleural cavity, considerable force may be required for this insertion. In some variations, it may be desirable to access the pleural cavity indirectly, such as through the patient's axilla. In the exemplary variation, insertion is completed when the insertion stabilization platform is placed against the patient's body.

[0058] In the optional step 1406, a small amount is aspirated from the pleural cavity using a syringe connected to the handle to confirm that the rapid deployment chest port is inserted to the correct depth. This step includes further adjustment of the depth of the rapid deployment chest port if necessary. The optional step 1406 may be performed simultaneously with step 1404.

[0059] In step 1408, the stabilization component is expanded at least within the patient's pleural cavity. In some variations, the stabilization component is an internal expansion flange. In some variations, the internal expansion flange is a balloon that is expanded by filling it with air through a syringe connected to an external valve port on the frame. In some variations, step 1408 optionally allows the insertion stabilization platform to be slid and locked into place on the patient's chest. At the end of step 1408, the rapid deployment chest port can be securely set in the patient at the appropriate insertion depth for the patient.

[0060] In step 1410, the plunger 704 is removed from the frame, and the check valve may be connected to a one-way valve at the proximal end of the frame via a Luer connector. In this embodiment, the stepped connector connected to the proximal end of the check valve can be connected to a suction source to remove air or fluid from the pleural cavity.

[0061] Finally, in step 1412, stabilizing components such as the internal expansion flange are deflated before the rapid deployment chest port is removed. In some cases, this may involve using a syringe attached to the external valve port to draw air out of the balloon. The rapid deployment chest port can then be safely removed from the patient's body.

[0062] Many embodiments of this disclosure are described herein. While this specification includes many specific implementation details, these should not be construed as limitations on the scope of disclosure or claims, but rather as descriptions of features specific to particular embodiments of this disclosure. Embodiments of this disclosure are described herein by example with several illustrative drawings, but those skilled in the art will recognize that this disclosure is not limited to the embodiments or drawings described. The drawings and detailed descriptions thereof are not intended to limit this disclosure to the disclosed embodiments, but rather should be understood as encompassing all modifications, equivalents, and substitutes that fall within the spirit and scope of the embodiments of this disclosure as defined by the appended claims.

[0063] The headings used herein are for structural purposes only and are not intended to be used to limit the description or claims. As used throughout this application, the word “may” is used in an allowable sense (i.e., a sense that has the possibility) rather than an essential sense (i.e., a sense that must have the meaning). Similarly, the words “include,” “including,” and “includes” mean “include,” but are not limited to these. For ease of understanding, similar reference numbers are used where possible to indicate common elements in the drawings.

[0064] The terms “at least one,” “one or more,” and “and / or” are open-ended expressions that function as both conjunctions and disjunctions. For example, each of the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, or C,” and “A, B, and / or C” means A alone, B alone, C alone, both A and B, both A and C, both A and C, and both B and C.

[0065] The term "a" or "a" entity means one or more of those entities. Thus, the terms "a" (or "an"), "one or more," and "at least one" are interchangeable here. Also, the terms "comprising," "including," and "having" are interchangeable.

[0066] Certain features described herein in relation to separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in relation to a single embodiment can also be implemented separately in multiple embodiments or in combination in any suitable subcombination. Furthermore, even if features act in a certain combination as described above and were initially claimed, one or more features from a claimed combination may be removed from the combination in some cases, and the claimed combination may be directed towards a subcombination or a variation of a subcombination.

[0067] Similarly, while the steps of a method may be shown in a specific order in the drawings, such actions should not be understood as requiring that they be performed in a specific order or sequential order, or that all illustrated actions be performed to obtain the desired result.

[0068] Certain features described herein in relation to separate embodiments can be implemented in combination in a single embodiment. Conversely, various features described in relation to a single embodiment can be implemented separately in multiple embodiments or in combination in any suitable subcombination. Furthermore, even if features act in a certain combination as described above and were initially claimed, one or more features from a claimed combination may be removed from the combination in some cases, and the claimed combination may be directed towards a subcombination or a variation of a subcombination.

[0069] Thus, specific embodiments of the subject matter are described. Other embodiments are within the scope of the following claims. In some cases, the actions described in the claims may be carried out in a different order, and the desired results may be obtained. Also, the processes described in the accompanying drawings do not necessarily require a specific order or sequence to obtain the desired results. Nevertheless, it should be understood that various modifications can be made without departing from the spirit and scope of the claimed disclosure.

Claims

1. Frame and A plunger having a blade at its distal end, wherein the plunger is contained within the lumen of the frame, A stabilization component configured to stabilize the frame inside and outside the patient's thoracic cavity, Includes a rapidly deployable chest port.

2. The rapid deployment chest port according to claim 1, comprising a plunger port attached to the proximal end of the frame.

3. A rapid deployment chest port according to any one of claims 1 or 2, comprising an external valve port attached to the outer diameter of the frame.

4. The rapid deployment chest port according to claim 3, wherein the external valve port is fluidly connected to the stabilization component.

5. The rapid deployment chest port according to any one of claims 1 to 4, wherein the stabilization component includes a single component configured to expand inside and outside the patient's thoracic cavity.

6. The rapid deployment chest port according to any one of claims 1 to 5, wherein the stabilization component includes a balloon.

7. The rapid deployment chest port according to claim 5, wherein the stabilizing component includes a portion of the frame that is compressed during insertion and expands to the contours of the internal and external tissues of the insertion site to prevent frame movement following deployment after insertion.

8. The rapid deployment chest port according to claim 6, wherein the compressed expandable portion of the frame is compressed by a peel-away introducer.

9. The rapid deployment chest port according to claim 8, wherein the peel-away introducer includes a finger grip, and the lower surface of the finger grip is within 7 cm of the blade to reduce the risk of damage to internal structures during insertion of the rapid deployment chest port.

10. The aforementioned stabilization component is An internal expansion flange attached to the outer diameter of the frame, An insertion stabilization platform attached to the outer diameter of the frame on the proximal side of the internal expansion flange, A rapid deployment chest port according to claim 1, comprising:

11. The rapid deployment chest port according to claim 10, wherein the internal expansion flange is a balloon structure or expandable structure comprising nitinol or a similar material suitable for generating a bending element.

12. The rapid deployment chest port according to any one of claims 10 or 11, wherein the insertion stabilization platform is slidable along the outer diameter of the frame.

13. The rapid deployment chest port according to claim 12, further comprising a fixation bend that allows the insertion stabilization platform to move toward the frame and then fix the insertion stabilization platform toward the frame.

14. The rapid deployment chest port according to any one of claims 10 to 13, wherein, in order to reduce the risk of damage to internal structures during insertion of the rapid deployment chest port, the insertion stabilization platform is within 7 cm of the blade when the rapid deployment chest port is inserted into the patient's pleural cavity.

15. A rapid deployment chest port according to any one of claims 10 to 13, comprising an external valve port attached to the outer diameter of the frame.

16. The rapid deployment chest port according to claim 15, wherein the external valve port is fluidly connected to the internal expansion flange.

17. A rapid deployment chest port according to any one of claims 2 to 16, comprising a handle having a connector, the handle having an operable connector so as to be detachably attached to the plunger port at the proximal end of the frame.

18. The rapid deployment chest port according to claim 17, further comprising a syringe port on which the handle can be operated to receive an aspiration syringe.

19. The rapid deployment chest port according to claim 17 or 18, wherein the plunger port is a one-way valve.

20. The rapid deployment chest port according to claim 16, wherein the external valve port is a one-way valve operable to receive a syringe to expand the internal expansion flange.

21. The rapid deployment chest port according to any one of claims 10 to 20, wherein the ratio of the diameter of the internal expansion flange to the diameter of the frame is 2.5 to 6.

22. The rapid deployment chest port according to any one of claims 1 to 21, wherein the blade has a conical shape.

23. The rapid deployment chest port according to any one of claims 1 to 21, wherein the blade is a needle.

24. A rapid deployment chest port according to any one of claims 1 to 23, comprising an external check valve assembly operable to connect to the plunger port and a suction source.

25. A method for removing air or fluid contained in the pleural cavity of a mammalian patient, Inserting the blade and the distal portion of the frame of the plunger of the rapid deployment chest port described in claim 1 into the patient's thoracic cavity, Expanding the stabilizing component so as to expand at least inside the thoracic cavity of the patient, Removing the plunger from the plunger port, A method that includes this.

26. The aforementioned stabilization component is An internal expansion flange attached to the outer diameter of the frame, An insertion stabilization platform attached to the outer diameter of the frame on the proximal side of the internal expansion flange, Includes, The method according to claim 25, wherein extending the stabilizing component includes extending the internal expansion flange.

27. Connecting the check valve and suction source to the plunger port, The method according to claim 25, further comprising removing air or fluid from the pleural cavity.

28. To contract the aforementioned stabilization component, To remove the rapid deployment chest port from the patient, The method according to claim 27, further comprising:

29. The method according to claim 25, further comprising preparing the insertion site into the thoracic cavity of the patient.

30. The method according to claim 25, further comprising aspirating a certain amount of air or fluid using a syringe attached to the handle of the rapid deployment chest port in order to confirm the placement of the rapid deployment chest port in the pleural cavity of the patient.

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