The disclosure relates to a method and apparatus for treating tension pneumothorax.
Tension pneumothorax is the progressive build-up of air within the pleural space, usually due to a lung laceration which allows air to escape into the pleural space but not to return. Progressive build-up of pressure in the pleural space pushes the mediastinum to the opposite hemithorax, and obstructs venous return to the heart. This leads to circulatory instability and may result in traumatic arrest.
Currently, the most effective treatment for tension pneumothorax is chest tube placement. Once a chest tube is inserted into the pleural space, usually through blunt dissection, the tension is decompressed. However, this takes time that the patient may not have and risks complications, including requiring suturing to secure the chest tube to the patient to reduce migration of the tube and the potential for creating inconsistent incision sizes that may lead to infection and/or requiring suturing.
Accordingly, the disclosure provides a method and apparatus for accessing a patient's pleural space using a rapid deployment chest port.
In a first aspect, the rapid deployment chest port includes a frame comprising a lumen and a plunger at least partially within a lumen of the frame. The plunger comprising a stylet shaft traversing the interior of the lumen of the frame and a needle operably connected to the distal end of the frame. A plunger enters the plunger port at the proximal end of the plunger. A balloon configured to expand in the interior of the chest cavity of the patient is attached to the outer diameter of the frame. An external valve port attached to the outer diameter of the frame is fluidly connected to the balloon, providing for balloon inflation. An insertion stabilization platform is slidable along the outer diameter of the frame and proximal to balloon.
In a second aspect, the tip of the needle comprising a concave curvature. In some aspects, the tip of the needle has multiple concave curvatures.
In a third aspect, the insertion stabilization platform is operably connected to a pinch locking stabilizer configured to reversibly immobilize the insertion stabilization platform.
In a fourth aspect, the device includes an external check valve assembly operable to connect to the plunger port after removal of the plunger. The external check valve assembly can include one or more of the following components: a connector configured to connect to the port, a valve outlet tubing operably associated with the connector, a check valve operably associated with the valve outlet tubing, and valve inlet tubing operably connected to the check valve and proximal to the check valve.
Additional aspects and features are set forth in part in the description that follows, and will become apparent to those skilled in the art upon examination of the specification or may be learned by the practice of the disclosed subject matter. A further understanding of the nature and advantages of the disclosure may be realized by reference to the remaining portions of the specification and the drawings, which forms a part of this disclosure.
The accompanying drawings, that are incorporated in and constitute a part of this specification, illustrate several embodiments of the disclosure and, together with the description, serve to explain the principles of the disclosure:
In the following sections, detailed descriptions of examples and methods of the disclosure will be given. The description of both preferred and alternative examples are exemplary only, and it is understood that to those skilled in the art that variations, modifications, and alterations may be apparent. It is therefore to be understood that the examples do not limit the broadness of the aspects of the underlying disclosure as defined by the claims.
For purposes of this description, “distal” refers to the end extending into a body and “proximal” refers to the end extending out of the body.
For purposes of this description “connected to” includes two components being directly connected or indirectly connected with intervening components.
The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. Alternative language and synonyms may be used for any one or more of the terms discussed herein, and no special significance should be placed upon whether or not a term is elaborated or discussed herein. In some cases, synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only, and is not intended to further limit the scope and meaning of the disclosure or of any example term.
The present disclosure provides generally for methods and an apparatus for treating tension pneumothorax using a rapid deployment chest port. According to the present disclosure, a rapid deployment chest port is inserted into the pleural area of a patient's body using a sharpened surface, such as a blade, needle, sharp tip, or knife edge. The sharpened surface may be attached to the rapid deployment chest port. Following insertion, the rapid deployment chest port may be expanded to open a cavity to relieve pressure from air and/or fluid buildup within the pleural space. In some variations, the rapid deployment chest port may further use suction to remove fluid from the pleural space.
The rapid deployment chest port allows for quick, standardized insertion of a chest tube without requiring creating an incision with a scalpel prior to insertion, as is current practice. Making an incision with a scalpel leads to inconsistent incisions that may be too large for the chest port, such that there may be an open wound around the chest port that may require suturing. Thus, the rapid deployment chest port provides less risk for infection in the patient because it creates a standardized incision that is the exact size needed for the rapid deployment chest port. In addition, a standard chest port requires suturing to stabilize the chest port so that it does not migrate within the patient. This requires additional time in the placement of the chest tube before the patient may be treated. The separate incision and suturing may lead to standard chest tubes taking several minutes to be inserted and ready for use. Because the rapid deployment chest port does not require a separate incision or any additional suturing, it provides for a reduction in the amount of time to insert the chest port and begin treating the patient. In some variations, the rapid deployment chest port may be deployed within 20 seconds. In some variations, the rapid deployment chest port may be deployed within 30 seconds. In some variations, the rapid deployment chest port may be deployed within 60 seconds. In some variations, the rapid deployment chest port may be deployed within 90 seconds.
Referring now to
In some variations, the blade 102 is a needle at the end of the hollow opening, having a concave curvature as depicted in
In some variations, the concave tip has a single concave tip. In some variations, the concave curvature can be configured to be greater than or equal to 10 degrees. In some variations, the concave curvature can be configured to be greater than or equal to 15 degrees. In some variations, the concave curvature can be configured to be greater than or equal to 20 degrees. In some variations, the concave curvature can be configured to be greater than or equal to 25 degrees. In some variations, the concave curvature can be configured to be greater than or equal to 30 degrees. In some variations, the concave curvature can be configured to be greater than or equal to 35 degrees. In some variations, the concave curvature can be configured to be greater than 40 degrees. In some variations, the concave curvature can be configured to be less than or equal to 45 degrees. In some variations, the concave curvature can be configured to be less than or equal to 40 degrees. In some variations, the concave curvature can be configured to be less than or equal to 35 degrees. In some variations, the concave curvature can be configured to be less than or equal to 30 degrees. In some variations, the concave curvature can be configured to be less than or equal to 25 degrees. In some variations, the concave curvature can be configured to be less than or equal to 20 degrees. In some variations, the concave curvature can be configured to be less than or equal to 15 degrees. Multiple concave curvatures can be formed in the tip, each with the same or different concave curvatures as other concave curvatures.
The blade 102 may be connected or connectable to a frame 104. Frame 104 may be comprised of any suitable material, such as plastic or steel. In other variations, 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, a frame 104 may be roughly pentagonal in shape, with one or more appendages extending from the point of the pentagon. Other shapes are within the scope of the disclosure. A non-limiting example of these one or more appendages is shown as the frame appendages 104A and 104B shown in the example variation of
Internal expanding flanges 106 are connected to the frame 104 near the blade 102. In some variations, the internal expanding flanges 106 may additionally include a sleeve, such as a mesh net. In other variations, the internal expanding flanges 106 include a balloon. The balloon may expand inside the pleural space to secure the rapid deployment chest port in place. In some variations, the internal expanding flanges 106 are made of a sufficiently rigid material to allow them to operate to force open a larger area within the pleural space. Similarly, external expanding flanges 120 may be made of the same rigid material. In other variations, the internal expanding flanges and the external expanding flanges may be made of a highly compliant material such that they may be operable to conform to the body and minimize damage to the body. The external expanding flanges 120 are located on the opposite end of the rapid deployment chest port 100 relative to the blade 102. The external expanding flanges serve to stop the downward movement of the rapid deployment chest port into a patient and thus, in some variations, rest on a patient's body upon insertion of the rapid deployment chest port 100. In some variations, the external expanding flanges 120 do not expand when the dial mechanism 122 is engaged. One or both of the internal expanding flanges 106 and external expanding flanges 120 may serve to secure the rapid deployment chest port 100 in place on the patient's body. As displayed in
Running throughout the frame 104 may be an internal expansion mechanism 110. The internal expansion mechanism 110 connects a dial mechanism 122, which may be located at the top of the rapid deployment chest port 100, to the internal and external expanding flanges 106 and 120, respectively. By way of non-limiting example, the internal expansion mechanism may comprise one or more of: a spring, chemical reaction, or a wheel. The dial mechanism 122 controls the expansion and contraction of the internal expansion mechanism 110. In example variations, the dial mechanism comprises a rotary element; however, any means for engaging, expanding, and contracting the internal expansion mechanism 110 is contemplated herein. By way of non-limiting examples of non-rotary dial mechanism variants, the dial mechanism may comprise a plunger, a button, a switch, a slide-ratcheting mechanism, or a digital controller capable of interfacing with a user by one or more of: Bluetooth, NFC, Wi-Fi, 3G, LTE, or touch screen. The dial mechanism may comprise a finite number of pre-determined settings, using a plurality of stops or a pawl, or it may adjust continuously. The dial mechanism 122 may assist in securing the rapid deployment chest port 100 in place,
Referring now to
Upon insertion, the rapid deployment chest port 100 may create an airtight seal between the pleural space and the exterior of the patient's body. In some variations, the external expanding flange 120 comprises a flexible material that molds to the shape of the patient's body. Upon expansion, then, air or fluid can only escape through the air escape opening 200. The air escape opening 200 divides the frame 104 horizontally and allows trapped air to escape from the patient's thorax. In example variations, when the rapid deployment chest port 100 is in an expanded state, an embedded check valve 108 is exposed. The check valve 108 may serve as a one-way valve for air moving throughout the air escape opening 200. The check valve 108 allows the air trapped inside the thorax to drain through the air escape opening 200 and out of the patient's body, while not permitting any additional air in. In other variations, the check valve 108 allows fluid trapped in the pleural space to be removed through the air escape opening 200 or a lumen in the frame and out of the patient's body. For example, increased pressure within the pleural space may cause air or fluid to move through the frame without use of a suction source. In other examples, the check valve may be connected to a suction source to further assist in air or fluid removal. In some variations, the check valve 108 comprises a passive, flexible, one-way valve such as a Heimlich valve. In some variations, the check valve 108 may be placed exterior to the rapid deployment chest port, as shown in
In some variations, a universal suction tube adapter 204 may be attached to the proximal end of the air escape opening 200. The universal suction tube adapter 204 may 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 needs of the situation and the chest tubes available. In some variations, the universal suction tube adapter may include a male or female luer connector. Thus, a doctor or other medical attendant may feed a chest tube into the patient's thorax cavity, in accordance with the current medical treatment for tension pneumothorax, and continue the safe removal of the trapped air or fluid. In some variations, when the rapid deployment chest port 100 is in an expanded state, the blade 102 may retract into the frame 104 at a blade retraction slot 202. The blade retraction slot 202 may be any means for ensuring that the point of the blade 102 is not exposed to the inside of the patient's body after retraction. In some variations, the blade retraction slot 202 may comprise a means for wiping the tip of the blade 102. Such means may include, for example, a narrow slot opening or an absorbent membrane. In some variations, the blade 102 is connected to the dial mechanism 122; thus, the retraction occurs due to the engaging of the dial mechanism 122. For example, if the dial mechanism 122 comprises a dial with pre-determined stops, the blade 102 may retract slowly as the dial mechanism 122 is turned. In other variations, such as where the dial mechanism 122 comprises a plunger or other binary engagement mechanism, the blade 102 may retract instantly upon engaging the dial mechanism 122.
In some variations, such as a variation in which the dial mechanism 122 is a plunger, activation of the dial mechanism 122 may cause several simultaneous reactions in the rapid deployment chest port 100. By way of non-limiting example, activating a plunger may do one or more of: extend the blade from the distal end of the frame; expand the external expanding flange 120; expand the internal expanding flange 106; retract the blade 102 into the blade retraction slot 202; deploy a sleeve from the internal expanding flange 106.
Referring now to
At step 302, the rapid deployment chest port 100 is inserted into the patient's body. Due to the durability of the thoracic cavity, this insertion may require considerable force. In some variations, it may be desirable to access the pleural space indirectly, such as through the patient's axilla. In example variations, the insertion is complete when the external expanding flange 120 rests against the patient's body.
At step 303, the dial mechanism 122 is engaged. In some variations, a sleeve around the internal expanding flange 106 will deploy when the rapid deployment chest port 100 is in an expanded state. In other variations, the internal expanding flange is a balloon that is deployed by filling it with air. In some variations, such as gradual engagement variations as when the dial mechanism 122 comprises a dial with pre-determined stops, one or more of the following expansion/contraction steps may occur gradually: (a) expand or slide the external expanding flange 120; (b) expand the internal expanding flange 106; (c) retract the blade 102 into the blade retraction slot 202 or into the lumen of the frame. In other variations, such as binary or instant engagement variations as when the dial mechanism 122 comprises a plunger, the aforementioned expansion/contraction steps may occur instantly or with minimal delay or discontinuities. Regardless, at the conclusion of step 302, the rapid deployment chest port 100 will be in at least a partially expanded state.
At optional step 304, air or fluid may exit through the air escape opening 200 via, in some variations, the universal suction tube adapter 204. The chest tube allows the tension pneumothorax treatment to proceed according to the current and known methods. In some examples, the plunger may be removed and a check valve, by way of a Leur connector, may be connected to a 1-way valve at the proximal end of the frame. In this example, a stepped connector connected to the proximal end of the check valve may be connected to a suction source to remove air or fluid from the pleural space.
Finally, at step 305, the dial mechanism 122 is engaged in reverse to contract the rapid deployment chest port 100. If the sleeve was deployed at step 303, it may wrap around one or more of: the internal expanding flange 106; the blade 102; the blade retraction port 202; the check valve 108; or the frame 102. When the internal expanding flange is a balloon, the method may further include deflating the balloon prior to removal of the rapid deployment chest port. The rapid deployment chest port 100 may then be safely removed from the patient's body.
Referring now to
Referring now to
Referring now to
Additionally, internal expanding flange 106 may have one or more groves or extrusions 602 to secure the frame 104 to an insertion stabilization platform 606. The insertion stabilization platform 606 may be integrated into the rapid deployment chest port 100 or be a separate piece through which the frame 104 and blade 102 can be inserted. The insertion stabilization platform 606 may assist in securing the rapid deployment chest port in place. The insertion stabilization platform 606 may comprise a balloon or pad, which balloon or pad may be stationary or adjustable. In some variations, the insertion stabilization platform 606 is adjustable by way of the extrusions 602. In some variations, extrusions 602 may comprise a sliding-ratcheting mechanism. In some variations, the insertion stabilization platform may have a coating of anesthetic or an anti-septic compound.
In some variations, rapid deployment chest port 100, as illustrated, may be modular. By way of non-limiting example, the rapid deployment chest port 100 may comprise three distinct pieces: a dial mechanism 122 (comprising finger grips 620, and a shaft linking the dial mechanism 122 to the blade 102); a frame 104 (comprising, as shown, the external valve port 610 and, in some variations, extrusions 602); and the optional insertion stabilization platform 606. In some variations, blade 102 may already be secured to the frame 104 or the insertion stabilization platform 606.
Referring now to
In some variations, the frame 104 may be compliant, such that it may be compressed. In additional variations, the frame 104 may be a catheter, such as a silicone catheter, or a thermo plastic or rubber extrusion. In some variations, the frame may include a lip to aid in the insertion of the rapid deployment chest port, such that the frame does not collapse during insertion. In other variations, the frame may not include a lip when a peel away introducer is used to reinforce the frame during insertion. In addition, the use of an introducer may compress the outer diameter of the frame at the site of insertion. Thus, in some examples, the diameter of the frame may depend on the use of an introducer. In a variation, the frame may have a diameter ranging from 5 French to 40 French. In some variations, the frame may have a diameter of 5 French. In some variations, the frame may have a diameter of 8 French. In some variations, the frame may have a diameter of 10 French. In some variations, the frame may have a diameter of 16 French. In some variations, the frame may have a diameter of 20 French. In some variations, the frame may have a diameter of 25 French. In some variations, the frame may have a diameter of 30 French. In some variations, the frame may have a diameter of 35 French. In some variations, the frame may have a diameter of 40 French.
In this variation, plunger 704 is connected to the blade 102 at the distal end and connected to finger grips at the proximal end. In other variations, the blade may be integrated with the plunger, such that they are a single element. For example, the plunger may have a tapered distal end, forming a blade. In other examples, the plunger may terminate in a blade. In some variations, the blade 102 may be any structure capable of piercing the skin and penetrating through the body to the pleural space. Non-limiting examples of blades include a needle, sharp tip, and/or or knife edge. In at least one example, the blade 102 may be a sharp silicone tip. In some variations, the finger grips may be a handle 702. The handle 702 may have an upper and lower portion, and the lower portion may be longer than the upper portion. In some variations, the upper and lower portions may be angled to provide an ergonomic handle. In some variations, the handle may be present to assist the user in guiding the rapid deployment chest port 700 to the desired spot. In a variation, the handle may further include a syringe port 720 at the proximal end of the handle. In an example, an aspiration syringe 722 may be attached to the syringe port 720 for testing the placement of the rapid deployment chest port 700. In this example, a user may 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 incorrect location, the user may adjust the placement by moving the handle towards or away from the patient, as appropriate. The aspiration syringe may again be used to test the placement of the rapid deployment chest port 700. The aspiration syringe 722 may be removed from the syringe port 720 on the handle once the correct placement of the rapid deployment chest port 700 is confirmed.
In some variations, the plunger structure may be removable from the frame 104. The plunger 704 may be inserted into the frame 104 through a plunger port 622 on the frame 104. In some variations, the plunger port 622 may be on a Y-hub 718. The plunger 704 may pass through a lumen in the frame and end in the blade 102. In some variations, the plunger port 622 may include a luer connector. In some variations, the handle may include a reciprocal luer connector 706 to connect the handle to the plunger port 622. The plunger 704 may be already inserted, and then removed. For example, the plunger 704 may be removed from the frame 104 when the rapid deployment chest port 700 is placed in the pleural space of the patient. In some variations, when the plunger 704 is removed, a reciprocal luer connector 708 may connect to the plunger port 622 to attach an external check valve assembly to the frame 104. The external check valve assembly may operate to allow a check valve to be inserted into frame 104 without the check valve needing to be integrated into rapid deployment chest port 700. In some variations, the check valve assembly may include the luer connector 708, a check valve 712, valve outlet tubing 710 connected to the luer connector and distal to the check valve, valve inlet tubing 714 proximal to the check valve, and a connector 716 to a suction source. In some variations, the connector may include a stepped connector. The stepped connector may attach to a suction source, such that fluid and/or air trapped in the pleural space may be pulled through the frame 104 and to the suction source. In some variations, when not in use or connected to the plunger port 622, the check valve assembly may be attached to the frame 104 by a strap 726 so that it may then me readily available when needed to connect to the plunger port 622.
The frame 104 may further include an external valve port 610 on the Y-hub 718. In some variations, the external valve port 610 may be a luer activated valve. The luer activated valve may be connected to a lumen in the frame 104, which may then be connected to the internal expanding flange. In some examples, a syringe 724 may connect to the luer activated valve to supply air to the internal expanding flange when the internal expanding flange is a balloon.
In some variations, the rapid deployment chest port includes a stabilizing component configured to stabilize the frame inside and outside the chest cavity of a patient. The stabilizing component may be a single component configured to expand in the interior and exterior of the chest cavity of the patient. In some variations, the single stabilizing component is a balloon, as seen in
In some variations, the external expanding flange is an insertion stabilization platform 606, as seen in
The insertion stabilization platform may be placed a distance from the blade and provide an external surface for securing the placement of the rapid deployment chest port 700. In some variations, the insertion stabilization platform 606 may rest on the patient when the rapid deployment chest port is inserted the proper distance. The location of the insertion stabilization platform may be adjustable. The insertion stabilization platform may be initially placed at a distance from the blade to mitigate the risk of injury to internal anatomy during insertion of the rapid deployment chest port. In some variations, the insertion stabilization platform may be located from 3 cm to 7 cm from the blade. Most patients' pleural spaces are within 6.5 cm from the surface of the body, thus an initial spacing of the insertion stabilization platform of 6.5 cm may allow the rapid deployment chest port to clear the thickness of most patients while limiting insertion depth to prevent internal injury. In a variation, the insertion stabilization platform 606 may not be adjustable beyond 7 cm from the blade 102.
In a variation, the insertion stabilization platform 606 may have one or more groves or extrusions 602, such as a fixation flexure, to secure the insertion stabilization platform 606 to the frame. The insertion stabilization platform 606 may be integrated into the rapid deployment chest port 700 or be a separate piece through which the frame 104 and blade 102 can be inserted.
In some variations, the insertion stabilization platform 606 is adjustable by way of the fixation flexure, as seen in
In some variations, the slidable insertion stabilization platform 606 may be coupled to a pinch locking stabilizer 910 as depicted in
In additional variations, the insertion stabilization platform 606 may form a seal around the frame to hold the insertion stabilization platform in place to limit initial insertion depth and prevent frame migration. For example, the insertion stabilization platform 606 may include a compression fitting, as seen in
In some variations, the rapid deployment chest port may include an internal expanding flange 106 connected to the frame 104 near the blade 102. In a variation, the internal expanding flange 106 may be a balloon, as seen in
In various aspects, the balloon may be made of silicone with a particular porosity. The silicone provides elasticity. The silicone balloon can also be bonded or otherwise connected to other components that are formed of silicone.
In some variations, the balloon thickness can be from 0.005″-0.060″. In further variations, the balloon thickness can be from 0.020″-0.040″. The balloon thickness can be greater than certain thicknesses. Alternatively or in addition, the balloon thickness can be less than certain thickness. In some variations, the balloon thickness can be at least 0.005″. In some variations, the balloon thickness can be at least 0.010″. In some variations, the balloon thickness can be at least 0.015″. In some variations, the balloon thickness can be at least 0.020″. In some variations, the balloon thickness can be at least 0.025″. In some variations, the balloon thickness can be at least 0.030″. In some variations, the balloon thickness can be at least 0.035″. In some variations, the balloon thickness can be at least 0.040″. In some variations, the balloon thickness can be at least 0.045″. In some variations, the balloon thickness can be at least 0.050″. In some variations, the balloon thickness can be at least 0.055″. In some variations, the balloon thickness can be less than or equal to 0.060″. In some variations, the balloon thickness can be less than or equal to 0.055″. In some variations, the balloon thickness can be less than or equal to 0.050″. In some variations, the balloon thickness can be less than or equal to 0.045″. In some variations, the balloon thickness can be less than or equal to 0.040″. In some variations, the balloon thickness can be less than or equal to 0.035″. In some variations, the balloon thickness can be less than or equal to 0.030″. In some variations, the balloon thickness can be less than or equal to 0.025″. In some variations, the balloon thickness can be less than or equal to 0.020″. In some variations, the balloon thickness can be less than or equal to 0.015″. In some variations, the balloon thickness can be less than or equal to 0.010″.
In other variations, the balloon can include a coating to reduce or eliminating porosity of the silicone balloon. Reducing or eliminating porosity can reduce or prevent leakage of fluid—whether gas or liquid—from the inside of the balloon, allowing the balloon to maintain its pressure once inflated.
The coating can be from any material that bonds to silicone in a very thin layer and reduces or prevents leakage of gas or liquid. In one variation, the coating is a paralene. Paralenes are poly(p-xylylene) polymers that when bonded to the silicone balloon, can reduce or prevent leakage of gas or liquid. In non-limiting variations, the paralene is paralene C, paralene N, or paralene X.
In various embodiments, the coating can have a thickness from 0.5-10 microns. In various embodiments, the coating can have a thickness range from 1.5-3.5 microns. The coating thickness can be greater than or equal to certain thicknesses. Alternatively or in addition, the balloon thickness can be less than or equal to certain thickness. In some variations, the coating thickness is greater than or equal to 0.5 microns. In some variations, the coating thickness is greater than or equal to 1.0 microns. In some variations, the coating thickness is greater than or equal to 1.5 microns. In some variations, the coating thickness is greater than or equal to 2.0 microns. In some variations, the coating thickness is greater than or equal to 2.5 microns. In some variations, the coating thickness is greater than or equal to 3.0 microns. In some variations, the coating thickness is greater than or equal to 3.5 microns. In some variations, the coating thickness is greater than or equal to 4.0 microns. In some variations, the coating thickness is greater than or equal to 4.5 microns. In some variations, the coating thickness is greater than or equal to 5.0 microns. In some variations, the coating thickness is greater than or equal to 5.5 microns. In some variations, the coating thickness is greater than or equal to 6.0 microns. In some variations, the coating thickness is greater than or equal to 6.5 microns. In some variations, the coating thickness is greater than or equal to 7.0 microns. In some variations, the coating thickness is greater than or equal to 7.5 microns. In some variations, the coating thickness is greater than or equal to 8.0 microns. In some variations, the coating thickness is greater than or equal to 8.5 microns. In some variations, the coating thickness is greater than or equal to 9.0 microns. In some variations, the coating thickness is greater than or equal to 9.5 microns.
In some variations, the coating thickness is less than or equal to 10.0 microns. In some variations, the coating thickness is greater than or equal to 9.5 microns. In some variations, the coating thickness is less than or equal to 9.0 microns. In some variations, the coating thickness is greater than or equal to 9.5 microns. In some variations, the coating thickness is less than or equal to 9.0 microns. In some variations, the coating thickness is greater than or equal to 7.5 microns. In some variations, the coating thickness is less than or equal to 7.0 microns. In some variations, the coating thickness is greater than or equal to 6.5 microns. In some variations, the coating thickness is less than or equal to 6.0 microns. In some variations, the coating thickness is greater than or equal to 5.5 microns. In some variations, the coating thickness is less than or equal to 5.0 microns. In some variations, the coating thickness is greater than or equal to 4.5 microns. In some variations, the coating thickness is less than or equal to 4.0 microns. In some variations, the coating thickness is greater than or equal to 3.5 microns. In some variations, the coating thickness is less than or equal to 3.0 microns. In some variations, the coating thickness is greater than or equal to 2.5 microns. In some variations, the coating thickness is less than or equal to 2.0 microns. In some variations, the coating thickness is greater than or equal to 1.5 microns. In some variations, the coating thickness is less than or equal to 1.0 microns.
In some variations, the coating is placed on the balloon when the balloon is partially inflated. The partial inflation allows sufficient coating to be placed on the balloon to coat the entire surface of the balloon, but not so much coating that the balloon cannot be compressed prior to deployment.
The diameter of the internal expanding flange may range from about 5 mm to 55 mm. In some non-limiting variations, the internal expanding flange may have a diameter of at least 5 mm. In some non-limiting variations, the internal expanding flange may have a diameter of at least 21 mm. In some non-limiting variations, the internal expanding flange may have a diameter of at least 27 mm. In some non-limiting variations, the internal expanding flange may have a diameter of at least 38 mm. In some non-limiting variations, the internal expanding flange may have a diameter of at least 52 mm. In some non-limiting variations, the internal expanding flange may have a diameter of less than or equal to 55 mm. In some non-limiting variations, the internal expanding flange may have a diameter of less than or equal to 52 mm. In some non-limiting variations, the internal expanding flange may have a diameter of less than or equal to 38 mm. In some non-limiting variations, the internal expanding flange may have a diameter of less than or equal to 27 mm. In some non-limiting variations, the internal expanding flange may have a diameter of less than or equal to 21 mm. In some non-limiting variations, the internal expanding flange may have a diameter of less than or equal to 15 mm. In some non-limiting variations, the internal expanding flange may have a diameter of less than or equal to 10 mm.
The diameter of the insertion stabilization platform may be selected based on the diameter of the frame to limit damage to the patient during insertion and removal. The internal expanding may be large enough to provide sufficient force to prevent dislodgment or frame migration during the course of normal events is desirable while mitigating the risk that the rapid deployment chest port can damage tissue or otherwise harming the patient if the frame is exposed to uncommonly large forces. In at least some variations, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame may range from 2.5 to 6. In one non-limiting variation, 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 variation, 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 variation, 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 variation, 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 variation, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame is less than or equal to 6.0. In one non-limiting variation, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame is less than or equal to 5.0. In one non-limiting variation, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame is less than or equal to 4.0. In one non-limiting variation, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame is less than or equal to 3.0. In at least one variation, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame may range from 3 to 5. In an example, the ratio between the diameter of the insertion stabilization platform and the diameter of the frame may be 5.
In other non-limiting examples, the balloon may be made of Urethan, Pebax or any other thermoformed or extruded material. In a variation, the balloon may have a volume of 2 mL to 10 mL when used with a 16 French frame. The volume of the balloon, and thus the diameter of the balloon, may be adjusted based on the diameter of the frame based on the ratio of internal expanding flange to frame diameter. In a variation, the balloon may have a volume of 2 mL. In a variation, the balloon may have a volume of 3 mL. In a variation, the balloon may have a volume of 4 mL. In a variation, the balloon may have a volume of 5 mL. In a variation, the balloon may have a volume of 6 mL. In a variation, the balloon may have a volume of 7 mL. In a variation, the balloon may have a volume of 8 mL. In a variation, the balloon may have a volume of 9 mL. In a variation, the balloon may have a volume of 10 mL.
The external valve port 610 may be fluidly connected to the stabilizing component to expand and deflate the internal expanding flange and/or insertion stabilization platform. In a variation, when the internal expanding flange is a balloon, the external valve port 610 may be fluidly connected to the internal expanding flange to facilitate the connection of a syringe to expand and deflate the balloon with air. The internal expanding flange may initially be deflated and against the outer diameter of the frame to aid in insertion of the rapid deployment chest port. In
The balloon and the insertion stabilization platform may be used in combination, on either side of the incision, to secure the rapid deployment chest port to the patient in the proper location. In some variations, the combination of the insertion stabilization platform and the internal expanding flange may allow the rapid deployment chest port to create an airtight seal between the inside and outside of the patient's body. This may allow for the efficient removal of air or fluid from the pleural space, reduce the risk of infection at the insertion site, and reduce the amount of time to treat the patient.
Referring now to
Referring now to
At step 1404, the rapid deployment chest port is inserted into the patient's body. In some variations, this may include inserting the blade of the plunger and distal portion of the frame of the rapid deployment chest port into the patient's chest cavity. Due to the durability of the thoracic cavity, this insertion may require considerable force. In some variations, it may be desirable to access the pleural space indirectly, such as through the patient's axilla. In example variations, the insertion is complete when the insertion stabilization platform rests against the patient's body.
At optional step 1406, a syringe connected to the handle is used to aspirate a small volume from the pleural space to confirm the rapid deployment chest port is inserted to the correct depth. This step may further include adjusting the depth of the rapid deployment chest port, if necessary. Optional step 1406 may occur simultaneously with step 1404.
At step 1408, the stabilizing component is expanded in at least the inside of the patient's chest cavity. In some variations, the stabilizing component is the internal expanding flange. In some variations, the internal expanding flange is a balloon that is expanded by filling it with air through a syringe connected to the external valve port on the frame. In some variations, step 1408 may optionally include sliding or locking the insertion stabilization platform such that it rests on the patient's chest. At the conclusion of step 1408, the rapid deployment chest port may be securely set in the patient at the proper insertion depth for the patient.
At step 1410, plunger 704 may be removed from the frame and a check valve, by way of a luer connector, may be connected to a 1-way valve at the proximal end of the frame. In this example, a stepped connector connected to the proximal end of the check valve may be connected to a suction source to remove air or fluid from the pleural space.
Finally, at step 1412, the stabilization component, such as the internal expanding flange, is deflated prior to removal of the rapid deployment chest port. In some examples, this may include withdrawing air from the balloon using the syringe attached to the external valve port. The rapid deployment chest port may then be safely removed from the patient's body.
A number of embodiments of the present disclosure have been described. While this specification contains many specific implementation details, there should not be construed as limitations on the scope of any disclosures or of what may be claimed, but rather as descriptions of features specific to particular embodiments of the present disclosure. While embodiments of the present disclosure are described herein by way of example using several illustrative drawings, those skilled in the art will recognize the present disclosure is not limited to the embodiments or drawings described. It should be understood the drawings and the detailed description thereto are not intended to limit the present disclosure to the form disclosed, but to the contrary, the present disclosure is to cover all modification, equivalents and alternatives falling within the spirit and scope of embodiments of the present disclosure as defined by the appended claims.
The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. As used throughout this application, the word “may” is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Similarly, the words “include”, “including”, and “includes” mean including but not limited to. To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures.
The phrases “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. 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, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.
The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted the terms “comprising”, “including”, and “having” can be used interchangeably.
Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in combination in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.
Similarly, while method steps may be depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in a sequential order, or that all illustrated operations be performed, to achieve desirable results.
Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in combination in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.
Thus, particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. In addition, the processes depicted in the accompanying figures do not necessarily require the particular order show, or sequential order, to achieve desirable results. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the claimed disclosure.
This patent application claims the benefit of U.S. Provisional Patent Application No. 63/034,852, entitled “Method and apparatus for Treating Tension Pneumothorax Using a Rapid Deployment Chest Port,” filed on Jun. 4, 2020, which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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63034852 | Jun 2020 | US |
Number | Date | Country | |
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Parent | PCT/US2021/035946 | Jun 2021 | US |
Child | 18074191 | US |