An airway management device and a method of manufacturing an object

Abstract

An airway management device having a main body (6) comprising an outer shell moulded from a polypropylene copolymer (PP) blended with a thermoplastic elastomer (TPE) styrene-ethylene / butylene-styrene (SEBS), the outer shell extending from a proximal opening of the main body (6) to a distal tip, the outer shell having a curved portion (35) and a straight portion (37). A method of manufacture is also disclosed.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 803,122, the disclosure of which is incorporated herein by reference. All publications, patents and patent applications mentioned in this specification are incorporated herein by reference as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Background Technology

[0003] Laryngeal mask airways (LMAs) have become an alternative to endotracheal tubes or face masks for airway management during general anesthesia. The “classic” LMA (CLMA) is an artificial airway device made of liquid silicone rubber (LSR) that includes a curved or flexible tube at one end leading to an oval, hollow, and inflatable mask portion. Its fit and function occupy space behind the larynx and seal around the perimeter of the laryngeal inlet. This device does not penetrate the interior of the larynx, thus avoiding vocal cord injury. A meta-analysis of 858 publications on CLMAs (Brimacombe, “The advantages of the LMA over the tracheal tube or face mask: a meta-analysis”, Can J.Anaesth, 1995; 42: 1017-23) determined that, compared to endotracheal tubes (ETTs) and face masks (FMs), CLMAs offer faster speed and easier placement, hemodynamic stability, and improved oxygen saturation. The single major drawback of CLMA compared to ETT is the higher gastric insufflation frequency, while for FM, the single major drawback is gastroesophageal reflux (GOR). Overall, it is noted that insertion techniques may not be fully defined, and therefore suboptimal positioning may affect the results. It is also noted that CLMA results in an increase in work of breathing (WOB) compared to ETT.

[0004] Subsequent studies (Roux M, Drolet P, Girard M, Grenier Y, Petit B, “Effect of thelaryngeal mask airway on oesophageal pH: influence of the volume and pressure inside the cuff”, Br J.Anaesth, April 1999; 82(4): 566-9) confirmed that, by comparing esophageal pH levels during anesthesia, the incidence of GOR was higher with CLMA compared to with a face mask and oropharyngeal airway. With CLMA, it was evident that the mean pH in the lower esophagus decreased and the percentage of time with pH below 4.0 increased. No definitive correlation was found between cuff pressure or inflation volume and the incidence of GOR.

[0005] Further research (Reissmann H, Pothmann W, Fclekrug B, Dietz R, Schulte amEsch J., “Resistance of laryngeal mask airway and tracheal tube in mechanically ventilated patient”, British Journal of Anaesthesiology, Vol. 85, No. 3, September 1, 2000, pp. 410-416) compared the inspiratory airflow resistance of CLMA and ETT in mechanically ventilated patients. Although the airflow resistance of a size 4 LMA should be less than that of an appropriately sized ETT (8.5 mm inner diameter), the mean airflow resistance of CLMA and larynx was not clinically relevant to the ETT due to the considerable variability in the anatomy between the LMA sealing against the larynx and the trachea. Furthermore, the study concluded that the presence of CLMA in the laryngopharynx may actually alter the geometry of the upper airway, leading to a narrowing of the glottic opening and further increasing airflow resistance.

[0006] Brain disclosed the intubating laryngeal mask airway (ILMA) in US Patent No. US6079409A. The flexible airway tube of the CLMA was replaced by a large-bore stainless steel tube with an anatomically curved proximal guide handle. Brain et al. concluded that, in preliminary evaluation, the ILMA appeared to be an effective ventilation device and intubation guide for patients with conventional and difficult airways who had no risk of gastric aspiration (Brain AIJ, Verghese C, Addy EV, Kapila A, Brimacombe J., “The intubating laryngeal mask. II: A preliminary clinical report of a new means of intubating the "Trachea" ("Intubation Laryngeal Mask, II: A Preliminary Clinical Report of a New Approach to Endotracheal Intubation", *British Journal of Anesthesiology*, Vol. 79, No. 6, December 1, 1997, pp. 704-709). Compared to the standard CLMA, the ILMA is equipped with a larger diameter but shorter airway tube, which is rigid enough to guide an ETT of appropriate length through the mask and into the glottis. Of 150 patients, 149 (99.3%) achieved successful endotracheal intubation using the ILMA, with 75 (50%) achieving success on their first attempt. In patients with underlying or known airway obstruction, the ILMA requires significantly fewer adjustments. The ETT used in the study was prototype, characterized by a straight cuff and a flexible silicone tube.

[0007] Located in the laryngopharynx and forming a barrier at the upper esophageal sphincter (OES), the main limitation of the CLMA and its variations is that the patient's lungs cannot be reliably protected from the reflux of gastric contents (Keller C, Brimacombe J, Bittersohl J, Lirk P, von Goedecke A., “Aspiration and the laryngeal mask airway: three cases and a review of the literature”, *British Journal of Anesthesiology*, Vol. 93, No. 4, October 1, 2004, pp. 579-582). Keller et al. evaluated three cases of aspiration using an LMA in which bile-stained fluid was removed from the trachea. In each case, the LMA was replaced by an ETT. In one of these cases, an ILMA was used, but aspiration occurred before intubation was performed. Therefore, prior assessment of aspiration risk is considered crucial in determining whether an LMA should be used and, if so, which type. The ILMA has been documented to have increased oropharyngeal leakage pressure compared to the CLMA, but the pharyngeal mucosal pressure is even higher and exceeds the capillary perfusion pressure. Therefore, the ILMA is not suitable as a routine airway management device and should be removed after intubation (Keller C, Brimacombe J., “Pharyngeal Mucosal Pressures, Airway Sealing Pressures, and Fiberoptic Position with the Intubating versus the Standard Laryngeal Mask Airway”, Anesthesiology, Vol. 90, No. 4, 1999, pp. 1001-1006). Supraglottic airway devices (where "supraglottic" means "above the larynx") have been classified as first-generation or second-generation (Cook T, Howes B., "Supraglottic airway devices: recent advances", Continuing Education in Anaesthesia Critical Care & Pain, Vol. 11, No. 2, April 1, 2011, pp. 56-61). Therefore, CLMA and ILMA are referred to as first-generation SADs (i.e., supraglottic airway devices) because neither can prevent gastric aspiration.

[0008] The LMA “Proseal” (PLMA) described in U.S. Patent Application Publication No. 2012 / 0211010A1 is a second-generation SAD because it is equipped with a built-in gastric drainage (GD) tube, thereby separating the digestive tract from the airway, allowing gastric juice to enter or escape, reducing the risk of gastric insufflation and pulmonary aspiration (Brain AIJ, Verghese C, Strube PJ., “The LMA ‘ProSeal’—a laryngeal mask with an oesophageal vent”, British Journal of Anesthesiology, Vol. 84, No. 5, May 2000, pp. 650-654). It is generally accepted that the laryngopharynx is normally closed in a resting state; however, any SAD that adequately occupies the laryngopharynx to form an esophageal seal and provide GD must open the esophagus and, in doing so, push the glottis forward (O'Neil MJ., “Mechanical closure of the vocal cords with the LMA ProSeal”, British Journal of Anesthesiology, 2002, Vol. 89, No. 6, pp. 936-937). Brimacombe et al. reported that vocal cord closure was associated with a decrease in the anteroposterior diameter of the glottic inlet when using the PLMA in patients with complete paralysis (Brimacombe J, Richardson C, Keller C, Donald S., “Mechanical closure of the vocal cords with Proseallaryngeal mask airway”, British Journal of Anesthesiology, 2002; 89: 296-7). The hypothesis posits that the vocal cord closure mechanism is caused by an inflatable cuff that compresses the glottic inlet along its anteroposterior axis, thereby reducing vocal cord tension and causing the arytenoid cartilage to rotate inward, leading to vocal cord closure. While overinflation of the cuff is not specifically mentioned, removing air from the cuff and moving the patient's head to an inspiratory position reduces the compressive force on the glottis, allowing the arytenoid cartilage to rotate outward and allowing the vocal cords to open. Brimacombe noted that mechanical vocal cord closure occurred in 4 out of 915 paralyzed patients treated with PLMA, and 17% experienced some degree of epiglottic folding, but airway obstruction was rare due to the auxiliary outlet below the drainage tube.In another reported case (Ghai A, Hooda S, Wadhera R, Kad N, Garg N., “Failed ventilation with LMAProseal in a patient with sleep apnea syndrome”, Anaesth Pain & Intensive Care 2013;17(1):94-96), after several failed attempts to overcome ventilation, the researchers removed the PLMA and replaced it with an alternative device. The authors cite Stacy et al. (Stacy MR, Sivasankar R, Bahlmann UB, Hughes RC, Hall JE., “Mechanical closure of the vocal cords with the airway management device”, British Journal of Anesthesiology, 2003;91:299), which reported a similar 20% airway obstruction rate to SAD. Stacy et al. hypothesized that the epiglottis folded downward or that the vocal cords closed mechanically. Inserting the PLMA beyond its optimal position resulted in near-complete airway obstruction, likely due to forward displacement of the glottic inlet.

[0009] The LMA “Supreme” (SLMA) disclosed in U.S. Patent Application Publication No. 2012 / 0145160A1 is also a second-generation SAD, characterized by an inflatable cuff and esophageal-gastric drainage tube (GD), but it is a disposable device made of semi-rigid PVC (polyvinyl chloride) and vinyl elastomer. A case study conducted by Bergmann et al. evaluated two methods of cuff inflation and device fixation of the SLMA to determine its effects on oropharyngeal leakage pressure, distal distal position in the laryngopharynx, gastrointestinal and airway dissociation, and perioperative airway morbidity (Bergmann I, Crozier TA, Roessler M, Schottola H, Mansur A, Buttner B, Hinz JM, Bauer M., “The effect of changing the sequence of cuff inflation and device fixation with the on device position, ventilatory complications, and airway morbidity: a clinical and fiberscopic study" (Using Effects of altered cuff inflation and device fixation sequence on device position, ventilation complications, and airway morbidity: a clinical and fiberoptic study (BMC Anesthesiology, 2014; 14:2, published online January 4, 2014, doi: 10.1186 / 1471-2253-14-2). The control method followed the manufacturer-recommended sequence of insertion, cuff inflation, and device fixation. The alternative “study” method involved device fixation before cuff inflation. No significant differences were observed in the incidence of hypoventilation or mispositioning, oropharyngeal leakage pressure, terminal position, or gastrointestinal and airway complications. Importantly, glottic stenosis also occurred at the same frequency. However, the incidence of glottic stenosis with ventilation impairment was significantly higher in the control group than in the study group. Sore throat, hoarseness, SLMA blood count, and dysphagia were significantly higher in the control group than in the study group. Another study comparing PLMA and SLMA (Lopez AM, Valero R, Hurtado P, Gambus P, Pons M, Anglada T., “Comparison of the LMA Supreme with the LMA Proseal for airway management in patients anaesthetized in prone position”, *British Journal of Anesthesiology*, 107(2): 265-71 (2011)) concluded that although the initial insertion rates of the two devices were similar, PLMA required fewer manipulations and exhibited slightly higher oropharyngeal leakage pressure. Laryngospasm had a similar incidence in both devices and was successfully treated by increasing the depth of anesthesia and administering neuromuscular blocking agents when necessary. Laryngospasm (Gavel G, Walker RWM, "Laryngospasm in anesthesia", Continuing Education in Anaesthesia CriticalCare & Pain, Vol. 14, No. 2, April 1, 2014, pp. 47-51) is described as persistent closure of the vocal cords, resulting in partial or complete loss of the patient's airway. This is a primitive reflex to prevent aspiration, but it can be problematic under general anesthesia. Therefore, it can be concluded that the pathogenesis of glottic stenosis or vocal cord closure can be mechanical or physiological, the latter being a result of nerve innervation during SAD insertion, or occurring if the degree of anesthesia is mild.

[0010] I-gel is another second-generation SAD, characterized by its non-inflatable cuff and the possibility of introducing a gastric tube (Theiler L, Gutzmann M, Kleine-Brueggeney M, Urwyler N, Kaempfen B, Grief R., "I-gel"). TM supraglottic airway in clinical practice: a prospective observational multicentre study (I-gel in clinical practice) TM Supraglottic airway: A prospective observational multicenter study (British Journal of Anesthesiology, 109(6): 990-5(2012)), to drain gastric juices. It relies on the soft SEBS (styrene-ethylene / butene-styrene) gel material of the cuff to conform to the anatomical differences at the laryngeal inlet. The authors noted the difficulty that occurred during insertion was due to the volume of the non-inflatable cuff, i.e., it could not deflate into a flat profile to facilitate passage through the teeth and tongue. Insertion and subsequent fixation resulted in the tongue protruding outward and being tightly clamped between the teeth and the proximal end of the relatively straight airway tube.

[0011] Studies on the esophageal sealing effect of I-gel in cadavers, compared to PLMA and SLMA, have shown that when the distal cuff of PLMA and SLMA is correctly positioned in the laryngopharynx, the corresponding sealing pressure is three times and two times that of I-gel, respectively (Schmidbauer W, Bercker S, Volk T, Bogusch G, Mager G, Kerner T., Oesophageal seal of the novel supralaryngeal airway device I-Gel). TM in comparison with the laryngeal maskairways Classic TM and ProSeal TM "using a cadaver model" (《Using a cadaver model for research on laryngeal mask airway Classic) TM and ProSeal TMCompared to the novel supraglottic airway device I-gel, this study highlights that the SAD cannot reliably prevent aspiration like the ETT. A magnetic resonance imaging study of the in vivo position of the I-gel compared to the SLMA by Russo et al. showed that both devices significantly affected the glottis, with the SLMA having a greater effect due to its larger inflatable cuff (Russo SG, Cremer S, Eich C, Jipp M, Cohnen J, Strack M, Quintel M, Mohr A., ​​“Magnetic resonance imaging study of the in vivo position of the extraglottic airway devices I-gel”). TM and LMA-Supreme TM "in anaesthetized human volunteers" (I-gel for extraglottic airway devices in anesthetized human volunteers) TM And LMA-Supreme TM (Magnetic resonance imaging study of the in vivo location of ILMA), British Journal of Anesthesiology, December 2012; 109(6): 996-1004. SLMA extends deeper into the UOS, while I-gel causes greater expansion in the upper layer of the UOS. The anatomical airway of SLMA has little effect on the soft tissue of the tongue, while the straighter and semi-rigid I-gel compresses the tongue, resulting in higher mucosal pressure. Although intubation can be performed through I-gel, the relatively straight airway of I-gel lacks anatomical curvature, reducing its rate of first intubation compared to ILMA.

[0012] In addition to the mechanical closure of the vocal cords, other nerve injuries can occur on the lingual side (Brimacombe J, Clarke G, Keller C. Lingual nerve injury associated with the ProSeal laryngeal mask airway: a case report and review of literature), British Journal of Anesthesiology, 2005; 95: 420-3, sublingual and recurrent laryngeal (Michalek P, Donaldson W, Votrubova E, Hakl M. Complications Associated with the Use of Supraglottic Airway Devices in Perioperative) Medicine (Complications associated with the use of supraglottic airway devices in perioperative medical treatment, International Journal of Biomedical Research, 2015, Article No. 746560, p. 13) Nerve injury has been reported in various case studies of both inflatable and non-inflatable cuffs. The most likely cause of such injury relative to the lingual side is pressure nerve injury from the airway tube (lingual side) or the cuff (sublingual and recurrent laryngeal). Two contributing factors are mentioned: the selection of an undersized PLMA (polymethyl methacrylate), resulting in an undersized cuff; and secondly, the use of nitrous oxide. Overinflation of an undersized cuff to improve sealing and a gradual increase in nitrous oxide diffusion within the cuff (Cros AM, Pitti R, Conil C, Giraud D, Verhulst J. Severe Dysphonia after Use of a Laryngeal Mask ("Severe Dysphonia after Laryngeal Mask Use", *Anesthesiology*, 1997; 86: 497-500), especially if the operation time is prolonged, increasing the pressure of the cuff. Regarding laryngeal nerve injury, Michaelk et al. concluded that the etiology of nerve injury is multifactorial, with the cuff being an important contributing factor, either due to excessive stiffness during insertion or direct compression of nerve structures upon placement.

[0013] Compared to the ETT, CLMA intubation offers faster speed and easier placement, hemodynamic stability, and better oxygen saturation. However, it does not reliably protect the lungs from reflux of gastric contents. Variants of the CLMA include the ILMA, configured with a larger diameter and shorter airway tube, which is rigid enough to guide the flexible ETT through the mask and into the glottis. ILMA intubation has been successful, but it does not provide an entry point or leakage point for gastric contents, thus reducing the risk of pulmonary aspiration. Furthermore, it is not recommended for use as a routine airway device.

[0014] The literature frequently mentions first-time insertion rate, cuff overinflation, and incorrect positioning. In describing the relationship between cuff pressure and volume, Bick et al. (Bick E, Bailes I, Patel A, Brain Al. Fewer sore throats and a better seal: why routine manometry for laryngeal mask airways must become the standard of care), *Anesthesiology*, December 2014; 69(12): 1304-8, demonstrated that inflatable cuffs change from negative elastic recoil at low volumes to positive recoil at high volumes. Without twisting or expanding the LSR cuff material, the recommended inflation volume for a size 4 CLMA is 30 ml. While the pharynx is less rigid than the trachea, it does significantly prevent expansion. Once inserted, it is inferred that the inflation volume required to maintain satisfactory oropharyngeal leakage pressure is actually less than 30 ml, thus this evidence suggests a link between sore throat and excessive cuff pressure. Increased mucosal pressure and inconsistency with the contours of the larynx, pharynx, and esophagus are also direct consequences of overinflation. LMA present in the laryngopharynx alters the geometry of the upper airway, causing narrowing of the glottic opening, thus further increasing airflow resistance and increased WOB compared to endotracheal intubation.

[0015] In summary, the characteristic bulky construction of second-generation SADs made of liquid silicone rubber (such as PLMA) or polyvinyl chloride elastomers (such as SLMA) plays a significant role in the pathogenesis of vocal cord closure and the cause or etiology of nerve damage. Regarding PLMA, U.S. Patent Application Publication No. 2012 / 0211010A1 (page 1, paragraph 005) teaches that drainage catheters must have sufficient rigidity at their distal end to withstand the pressure of an inflated cuff, and it has been found that this can make proper insertion of the deflation device into the patient's throat more difficult, even if such insertion is necessary or desired.

[0016] U.S. Patent Application Publication No. 2012 / 0211010A1 discloses a reinforced rear flap 27 that is thicker than the first-generation SAD (page 9, paragraph 0111). This includes what is described as a rear bladder 65 (…). Figure 7 and Figure 8 The inflatable volume of the rear bladder 65, formed by a flexible panel 62 (page 4, paragraph 0051), covers the rear baffle 27 and is bonded to the rear of the main bladder 40 along the perimeter 63. The main bladder 40 and the rear bladder 65 are interconnected for simultaneous inflation. Upon inflation, the pressure within the rear bladder 65 presses against the elliptical portion of the rear baffle 27, causing it to bulge forward and potentially displace the internal drainage conduit 115 forward. To mitigate this, the reference teaches that the rear baffle must be thickened and molded using a liquid silicone rubber (LSR) material with a higher indicated hardness than that of the first-generation SAD. To offset the additional volume of this construction, the flexible panel 62 is molded into a thin sheet of LSR capable of significantly elongating in response to internal expansion pressure.

[0017] Functionally (page 9, paragraph 0108), inflation of the main cuff 40 causes expansion of the distal region 45, allowing it to abut and fit against and conform to the pharynx 197 and laryngopharynx 212. Upon further inflation, the posterior cuff 65 results in an initial engagement between the flexible panel 62 and the posterior surface of the pharynx 197. Pressure within the posterior cuff 65 pushes the main cuff 40 forward, compressing the tissue surrounding the laryngeal inlet 67. This strengthens the sealing engagement between the main cuff 40 and the tissue surrounding the laryngeal inlet 67, thereby reducing leakage between such tissue and the main cuff 40. An initial description of this configuration in the installed and inflated state is given in paragraph 0051 on page 4. Specifically, an increased anterior-posterior space characterized by a minimum depth of 10 mm is measured between the anterior tangent of the internal drainage conduit 115 and the plane described by the anterior surface of the main cuff 40 (Figure 9 “b”). To maintain the ideal anterior-posterior dimensions, the distal orifice 123 must be wedged into the superior esophageal sphincter so that the internal drainage catheter 115 is surrounded by an annular inflatable volume after the main cuff 40 is inflated.

[0018] Furthermore, U.S. Patent Application Publication No. 2012 / 0211010A1 teaches that overinflation of the posterior cuff 65 (page 9, paragraph 0109) will cause the elliptical portion 87 of the posterior baffle 27 to bulge forward, resulting in displacement of the internal drainage duct 115 relative to the main cuff 40 and loss of the aforementioned anterior-posterior space. If this anterior-posterior space is reduced below a minimum level, the internal drainage duct may impinge on the anatomical structures of the larynx 32, which is normally located in the laryngeal cavity region 110. Therefore, reported cases of vocal cord closure are associated with a reduction in the anterior-posterior diameter of the glottic inlet when using PLMA.

[0019] Similarly, the SLMA in U.S. Patent Application Publication No. 2012 / 0145160A1 (page 1, paragraph 0010) has a gastric drainage opening at the distal end of a mask that can be applied directly to the throat and pharynx. This results in such a mask being bulky and overly rigid, making it difficult to insert correctly. Specifically, (page 2, paragraph 0013) in any such device, regardless of the material it is made of, the addition of esophageal drainage itself greatly increases the complexity of manufacture and also affects the device's performance in terms of ease of insertion, seal formation, and prevention of blow-in.

[0020] The use of PVC or similar high-performance viscous polymers further exacerbates this complexity. Viscous polymers have a viscosity coefficient, or strain rate, that varies over time. The release of energy after a load is applied and then removed is not immediate but time-varying. This characteristic viscosity coefficient leads to posterior folding and over-folding of the main cuff or distal portion of the cuff during insertion and subsequent manipulation of the SAD by various methods (not limited to rotation and tilting), as described in Anaesthetic and respiratory equipment—Supralaryngeal airways and connectors, ISO 1 1712:2009(E). Such folding results in improper seal formation and a high probability of inflatable air.

[0021] Furthermore, the need to provide a drainage tube that seals against the airway and passes through the inflatable cuff presents particularly challenging problems. In terms of functional impact, providing a drainage tube results in unacceptable hardening of the mask end region and obstruction and / or restriction of the airway pathway. The relatively rigid PVC airway tube 2 of the SLMA (page 3, paragraph 0049) includes a groove or channel 20 configured on either side 18 and 19 of the airway tube 2. Figure 1 , Figure 3 (and Figure 10) to improve flexibility during insertion and prevent kinking. The esophageal drainage tube 41 is inserted into the airway tube 2 (page 4, paragraph 0062) and secured to the connector body 43 at the proximal end and the rear baffle 4 at the distal end by adhesive. This provides fluid communication in the small hole 49, separate from the fluid communication in the large hole 48 (i.e., the interior of the airway tube 2). The addition of ribs and channels increases the volume of the assembled device 1, and the external grooves and channels (20) form ridges along the inner surface of the side of the airway tube, reducing the internal space of the airway tube 2. The esophageal drainage tube 41 occupies the central plane of this internal space. Aligned with the connector body 43 and the plug 45 and bonded to the connector body 43 and the plug 45 by adhesive, the configuration of the esophageal drainage tube 41 effectively obstructs intubation.

[0022] Alternative SADs with non-inflatable cuffs show less glottic displacement, but correspondingly lower esophageal sealing pressure. In this situation, the enlarged airway cannot provide anatomical curvature, compressing the tongue and causing it to protrude outwards, subsequently increasing mucosal pressure. While intubation is possible, the maximum size of the ETT is smaller than the recommended size for the same weight; for example, a size 4 I-gel accommodates an ETT with an inner diameter of 7.0 mm, while the recommended ETT inner diameter for the same body weight is 8.0 mm to 8.5 mm.

[0023] Typically, esophageal drainage catheters must pass through an inflatable cuff, which presents particularly challenging manufacturing problems. Furthermore, the placement of the drainage catheter results in unacceptable hardening of the distal end, affecting performance in terms of ease of insertion, seal formation, and prevention of air inflation. The semi-rigid PVC and PVC elastomers commonly used in disposable SADs exacerbate these difficulties, as acceptable flexibility requires increased thickness, which in turn leads to a larger volume.

[0024] Nevertheless, a single-use SAD is still required, which can combine gastric drainage and endotracheal intubation of an appropriately sized ETT through an anatomically curved airway and can also be used as a routine airway management device; and unlike previous methods, the size of the device can be significantly reduced by not exposing the esophageal drainage tube (or gastric drainage tube) to the inflation pressure inside the cuff.

[0025] WO2015119577 describes an airway management device comprising a body having a distal end and a proximal end for receiving an oxygen supply tube. To reduce the volume of the distal end, the overall volume of the device must be reduced proportionally. This eliminates the use of adhesives and redefines manufacturing methods and material selection. Past approaches have proposed treating the passages or conduits for fluid communication as separate or independent components. No attempt has been made to combine these passages so that their wall thicknesses and characteristics can be shared, thereby reducing the overall volume. Besides the fact that the cuff portion of the SAD is confined to a gel-like material that cannot be deflated for insertion (I-gel), the rheological relationship between polyolefins such as polypropylene (PP) and block copolymers such as SEBS (styrene-ethylene / butene-styrene) has not been fully utilized. SEBS is a thermoplastic elastomer (TPE) characterized by hard and soft domains in individual polymer bundles. The terminal blocks of these bundles are crystalline styrene, while the intermediate blocks are soft ethylene-butene blocks. These bundles are joined at the styrene end blocks, forming a physical crosslink that provides rubber-like elasticity.

[0026] Therefore, it is determined that there is a need for an improved airway management device that overcomes some or all of the aforementioned limitations or other limitations to be discovered. Summary of the Invention

[0027] According to one aspect of this disclosure, an airway management device is provided. In one embodiment, the device includes a body comprising a shell molded from a polypropylene copolymer (PP) blended with thermoplastic elastomer (TPE) styrene-ethylene / butene-styrene (SEBS), the shell extending from a proximal opening of the body to a distal end, the shell having curved portions and straight portions.

[0028] In some embodiments, the device further includes an intermediate strip molded from a polypropylene copolymer (PP). The intermediate strip may be attached to the housing midway between the curved and straight portions.

[0029] In some embodiments, the device may further include a first SEBS overmolded portion, the first overmolded portion including a rear profile and a distal profile on the housing. The first overmolded portion may include a distal periphery defining a first opposing edge of an overmolded sheath membrane extending tangentially from the periphery in an annular curve, the endpoints of the annular curve being spaced apart from and orthogonal to the first opposing edge, the endpoints defining an opening rear periphery or a second opposing edge and a straight portion overmolded proximal end, such that the curved portion and the straight portion are combined into a single molded element by sealing the gap using the planar seals of the first and second sides of the intermediate strip. A second SEBS overmolded portion may close the opening length of the membrane to form an inflatable sheath.

[0030] In some embodiments, the posterior contour of the body is adapted to be located within the laryngopharynx, and the distal end is adapted to be located within the superior esophageal sphincter, forming an esophageal seal immediately above the distal opening. The anterior composite curvature of the housing is the internal posterior surface of the channel or gastric drainage catheter, thereby reducing the volume of the distal end. The device may also include a surrounding contour that covers and molds the anterior composite curvature of the housing, and the surrounding contour is adapted to be positioned and pressed against the laryngopharynx, the full-length configuration of the housing from distal to proximal providing resistance against upward displacement of the distal opening due to increased esophageal pressure. The drainage catheter and its distal opening may be integral with the distal posterior contour not surrounded by the annular volume of an inflatable cuff.

[0031] The closed tubular segments of the device can form cavities, thereby providing space for the distal portion of the inflatable cuff, which shifts posteriorly upon inflation. In some embodiments, a first edge and a second edge are provided through any horizontal cross-section of the inflatable cuff, at least for the length of the distal portion of the gastric drainage catheter. These edges may be generally or approximately parallel to the midline plane of the curved portion, such that the width between the first and second edges after a second overmolding is equal to the outer diameter of the distal drainage catheter. The curvature of the inflatable cuff membrane between the first and second edges is a single continuous curvature with uniformly indicated stiffness, thereby sealing posteriorly against the laryngopharynx and anteriorly against the laryngeal inlet without adhesive joints.

[0032] This disclosure also relates to a method of using an airway management device. The method may include providing a removable connector / adapter on the straight portion to reduce the length from the proximal opening of the body to the trachea, thereby providing additional insertion depth to the distal end of the endotracheal tube. A method of using an airway management device is also disclosed, comprising providing a finger restraint that forms a fixed position for resting the thumb during insertion to grasp the proximal end when the device is removed after intubation, and serving as a depth indicator relative to the teeth when the device is in place.

[0033] This disclosure also relates to a method of forming an airway management device. The method includes providing a body comprising a polypropylene copolymer (PP) and a thermoplastic elastomer styrene (TPE) ethylene-ethylene / butene-styrene (SEBS). The body includes a shell molded from a predominant PP copolymer blended with SEBS, the shell extending from a proximal opening of the body to a distal end.

[0034] The method may further include attaching an intermediate strip molded from a polypropylene copolymer to the outer shell at the midpoint between the curved and straight portions of the body. More specifically, the method may include providing a first SEBS overmolded portion including an initial rear profile and a distal profile overmolded onto the outer shell. The distal periphery of the first overmolded portion defines a first opposing edge of an overmolded sheath membrane extending tangentially from the distal periphery in an annular curve. The endpoints of the annular curve are spaced apart from and orthogonal to the first opposing edge, the endpoints collectively defining a rear opening periphery or a second opposing edge. The straight portion overmolds the proximal end, thereby combining the curved and straight portions into a single molded piece by sealing gaps using the transverse lateral planes of the intermediate strip. The method may further include providing a second SEBS overmolded portion to close the membrane, thereby forming an inflatable sheath and completing the body.

[0035] Independent of or dependent on the foregoing, this disclosure also relates to a method of forming an object, which can be applied to airway management devices, but may also have broader applications. The method includes injecting a first portion of the molded object onto a first core associated with a fixation device. After the first portion has been injection molded, the method includes moving a second core associated with the fixation device to a deployment position. The method also includes injecting a second portion of the molded object onto the second core and the first portion.

[0036] In some embodiments, the step of moving the second core associated with the fixing device to the deployment position includes rotating the second core relative to the fixing device. In some embodiments, the method includes attaching a preformed part to an object. The method further includes placing one or more removable cores into the object and placing one or more removable cores within an injection mold prior to molding a second portion of the object. The method further includes overmolding a film that forms part of the second portion of the object.

[0037] The method may further include the step of injection molding a third portion of the closed and sealed membrane to form an inflatable portion of the object. The method may also include removing a removable core from the membrane of the object prior to injection molding the third portion.

[0038] In some embodiments, the step of injection molding the first portion is performed in a first mold including a fixing device. The step of injection molding the second portion can be performed in a second mold including a fixing device. The step of injection molding the third portion to close and seal the film can be performed in a third mold including a fixing device.

[0039] The method may further include a step of transferring the retainer from a first mold to a second mold between the steps of injection molding a first portion and a second portion of the object. The step of injection molding the first portion of the object onto a first core associated with the retainer includes forming a shell of the object. The method may further include the steps of moving the first core to release the proximal end of the object and removing the object from the second core of the retainer. The method may include providing a body comprising a polypropylene copolymer (PP) and a thermoplastic elastomer (TPE) styrene-ethylene / butene-styrene (SEBS), characterized in that the first portion comprises a shell molded during a first injection molding step from a predominant PP copolymer blended with SEBS, the shell extending from a proximal opening of the body to a distal end. Any of these methods can be used to manufacture or form an airway management device.

[0040] Another aspect of this disclosure relates to an apparatus for forming injection-molded objects. The apparatus includes a reconfigurable fixing device comprising a first movable core and a second movable core, on which a first portion of the injection-molded object is formed, and on the second movable core, a second portion of the injection-molded object is formed. In some embodiments, the first movable core is adapted to rotate relative to the fixing device, and the second movable core is also adapted to rotate relative to the fixing device.

[0041] In some embodiments, the first removable core is adapted to be removably attached to a fixing device. The first removable core may include a connector for connecting to the fixing device, and a handle. The fixing device may include a retainer, such as a spring, for holding the second removable core in a deployed position.

[0042] Another aspect of this disclosure relates to a method of manufacturing an airway management device. The method includes providing a tubular body having straight and curved portions, the tubular body including a plurality of supports adjacent to a rear channel. The method further includes providing an intermediate strip that engages with the plurality of supports and is positioned above the rear channel. The method also includes overmolding material onto the intermediate strip.

[0043] In some embodiments, the method includes the steps of: (1) injection molding a first portion of the body of the airway management device onto a first core associated with a fixing device; (2) after injection molding the first portion, moving a second core associated with the fixing device to a deployment position; and (3) injection molding a second portion of the body onto the second core and the first portion of the body. The step of moving the second core associated with the fixing device to the deployment position may include rotating the second core relative to the fixing device.

[0044] In some embodiments, the method further includes the steps of: placing one or more removable cores in a tubular body, placing one or more removable cores in a second injection mold, and overmolding the removable cores with a membrane that is part of a second portion of the body. The method may further include removing the removable cores from close proximity to the first and second cores, leaving an open membrane, and overmolding the second portion with a third portion that closes and seals the open membrane to form an inflatable sheath on the tubular body. The method may further include the steps of moving the first removable core and removing the removable cores to release the tubular body.

[0045] In some embodiments, the method may include placing a first material in one or more gaps adjacent to an intermediate strip containing the first material. The method may also include the step of melting a portion of the intermediate strip containing a second material to diffuse the first material into the second material.

[0046] Another aspect of this disclosure relates to a method of forming an object. The method includes injecting a first portion of the molded object onto a first core associated with a fixing device in a first injection mold. The method further includes placing the fixing device in a second injection mold and injecting a second portion of the molded object onto a second core associated with the fixing device and partially or entirely onto the first portion. Furthermore, the fixing device is placed in a third injection mold, and a third portion is injected onto the first and second portions to form a molded object.

[0047] In some embodiments, the first core is movable relative to the fixing device, and the method further includes a step of moving the first core after injection molding a first or second portion of the molded object. The step of injection molding a second portion of the molded object may include injection molding on a second core associated with the fixing device. The second core may be movable relative to the fixing device, and the method may further include a step of moving the second core to a deployment position after the step of injection molding the first portion of the molded object and before the step of injection molding the second portion of the molded object.

[0048] In some embodiments, the method may further include placing one or more removable cores within a second injection mold prior to the step of injection molding a second portion of the object. The step of injection molding the second portion of the object may include overmolding an open membrane onto the one or more removable cores. The one or more removable cores may be removed from the second injection mold along with a retaining device. Furthermore, after injection molding the second portion of the object and before injection molding the third portion, the one or more removable cores may be removed from the open membrane. The method may further include the step of closing and sealing the open membrane to form an inflatable portion of the object.

[0049] The disclosed apparatus and methods can be used to form any object, including but not limited to airway management devices of any size, shape or form. Attached Figure Description

[0050] Figure 1 This is an isometric view of the main body of an airway management device according to one embodiment;

[0051] Figure 2 It is used for Figure 1 An isometric view of the insert of the main body;

[0052] Figure 3 yes Figure 1 An isometric view of the main body;

[0053] Figure 4 yes Figure 2 An isometric view of the insert;

[0054] Figure 5This is an isometric view of the oxygen supply adapter of an airway management device according to another embodiment;

[0055] Figure 6 is Figure 7 A cross-sectional view of the main body;

[0056] Figure 6a is Figure 7 A detailed cross-sectional view of the main body;

[0057] Figure 7 yes Figure 1 An isometric view of the main body;

[0058] Figure 8 yes Figure 1 An isometric view of the main body;

[0059] Figure 9 is Figure 1 Elevation view of the main body;

[0060] Figure 10 is Figure 1 A plan view of the main body;

[0061] Figure 11 This is a front view of the main body of an airway management device according to another embodiment;

[0062] Figure 12 yes Figure 11 The rear view of the main body;

[0063] Figure 13 is Figure 12 A detailed cross-sectional view of the main body;

[0064] Figure 14 is Figure 12 A detailed cross-sectional view of the main body;

[0065] Figure 15 yes Figure 12 An isometric cross-sectional view of the main body;

[0066] Figure 16 is Figure 12 An isometric view of the main body;

[0067] Figure 17 is an isometric view of the receiving tube of the airway management device;

[0068] Figure 18 This is the back of the main body of the airway management device;

[0069] Figure 19 This is the back of the main body of the airway management device;

[0070] Figure 20 is Figure 18 Side elevation view of the main body;

[0071] Figure 21 is Figure 19 Side elevation view of the main body;

[0072] Figure 22 yes Figure 18 Rear elevation view of the main body;

[0073] Figure 23 yes Figure 19 Rear elevation view of the main body;

[0074] Figure 24 This is an isometric view of the main body of the airway management device;

[0075] Figure 25 yes Figure 24 An isometric view of the main body;

[0076] Figure 26 This is a front view of the main body of an airway management device according to another embodiment;

[0077] Figure 27 yes Figure 26 A front view of a partial cut in an embodiment;

[0078] Figure 28 yes Figure 26 A partial cross-sectional enlarged end view of an embodiment;

[0079] Figure 29 yes Figure 26 A cross-sectional side view of an embodiment;

[0080] Figure 30 Is / present Figure 26 Cross-sectional views of embodiments under different operating conditions;

[0081] Figure 31 This is a side view of another embodiment;

[0082] Figure 32 yes Figure 31 Isometric views of the embodiments; and

[0083] Figure 33 and Figure 34 This is a view of the in-place airway management device.

[0084] Figures 35-45 This relates to a method of forming objects (such as...) using injection molding technology. Figures 1-34 Methods for (airway management devices). Detailed Implementation

[0085] Now for reference Figures 1-34 Various embodiments of an airway management device are disclosed. The airway management device includes a body 6, such as an airway duct extending from a proximal end 1 of the device to a distal end 2. Figure 1 and Figure 3The horizontal cross-section AA (Fig. 6) of the straight portion passing through the proximal airway duct shows the main passage 3 and the secondary passage 4 configured on either side of the midline plane. This configuration forms a shell that provides a larger first area moment than a circular or elliptical cross-section of similar size. This provides the device with sufficient flexural strength, thus acting as an exoskeleton compared to prior art devices where most of the flexural strength comes from internal components, thus representing an internal skeletal structure.

[0086] adapter( Figure 5 (and Figure 17) is inserted into the proximal opening of the airway tube, which facilitates connection to the oxygen supply source and combines it into a more rigid structure capable of handling and facilitating circumferential forces during insertion. The parallel and sagittal plane relationship of the two pathways defines an additional local posterior channel 5, which, along with the intermediate strip ( Figure 2 and Figure 4 Together, they form a third, laterally offset pathway to facilitate gastric drainage.

[0087] Parallel to the midline plane, cross section AA of Figure 6 travels downward through an anatomically approximate curvature of approximately 101 degrees (Figure 9), thus transitioning from a closed cross section to an open cross section that coincides with the ventral opening of device 7. Figure 8 (See Figure 9). The main and secondary pathways terminate at the ventral opening. Within this opening, the main pathway provides gas communication. When the adapter is removed, the main pathway 3 allows for blind intubation (Figure 10). The secondary pathway 4 provides endoscopic access during blind intubation and provides a secondary pathway for spontaneous breathing during blind intubation.

[0088] The transition continues downwards, with the airway tube cross-section maintaining the semi-circular profile of the posterior local channel 5 until reaching the proximal end 8 of the median groove 9, a feature consistent with the anterior or ventral opening. When viewed forward toward the anterior plane (Figures 6 and 10), the median groove provides a progressively curved path for gastric drainage from the posterior local channel 5 through the median groove to the anterior side of the distal airway tube; aligning the gastric drainage path with the median plane of the distal end 10; allowing the gastric drainage tube or aspiration tube to pass through with minimal frictional resistance.

[0089] Intermediate strip ( Figure 2 and Figure 4Attached to the posterior portion of the airway tube, the intermediate strip exhibits a curvature in the sagittal plane that matches the airway tube and horizontal cross-section 11, thus providing geometric consistency and attachment to the airway tube (Figures 6 and 6a). The proximal intermediate strip (Figures 9 and 10) is defined by a tubular feature 12, which serves as the entry point for a gastric drainage tube or aspiration tube; and when viewed from the side, the central axis of the tubular feature 12 forms an angle of approximately 23.5 degrees with the horizontal plane, which coincides with the central axis 13 passing through the proximal end of the airway tube (Figures 9 and 21). When positioned on the airway tube, the intermediate strip covers a partial posterior channel 5, which is essentially an elongated recess, together defining a third pathway as a gastric drainage path. Once positioned, the intermediate strip is flush with the outer surface of the device body. The distal end of the intermediate strip terminates at the proximal end of the median groove 8. Continuing downwards to the distal end 2, the width of the airway tube cross-section and the first area moment gradually decrease. The horizontal cross-section running through this transition section exhibits a ventral concave curvature, meaning that the rear contour portion 34 continues to maintain the intermediate strip ( Figure 2 , Figure 4 (and Figure 9), until the distal end of the airway tube.

[0090] When combined with the elastic properties of polyolefin materials, the ventral concave curvature 33a parallel to the central groove and the ventral concave curvature 33b horizontally passing through the central groove produce a composite curvature that promotes the immediate elastic response of the polyolefin material during flexure. Figure 15 Alternatively, a local conical spring (Bassbury washer) can be used to maintain contact between the posterior airway tube and the posterior laryngopharynx during insertion without excessive force leading to comorbidities and soft tissue damage.

[0091] In purely mechanical terms, the distal end of the airway tube can be considered a fixed support, while the airway tube itself can be considered as acting as a cantilever beam. The force applied during insertion through the straight proximal portion of the airway tube is concentrated and bends and extends through a horizontal axis coinciding with two laterally opposed grooves 23. The diameter of the main passage is larger than that of the secondary passage, allowing a degree of rotation about the central axis of the proximal airway tube, which can be transmitted as a torsion through to the distal end. Using semi-rigid PVC as the SAD (Self-Adhesive Aqueduct) for the airway tube operates in a viscous manner, meaning that when a force is applied, they resist shear and exhibit linear strain (the relationship between length and original length changes) for the duration of the applied force. However, these forces are dispersed within the PVC material, such that when the force is released, the PVC does not immediately respond and return to its original state. This energy loss or hysteresis is a significant drawback of existing technologies based on PVC materials. Polyolefin materials (such as polypropylene) exhibit excellent viscoelastic responses, characterized by elasticity rather than viscous response.

[0092] During insertion, the forces transmitted through the airway tube manifest as a circumferential motion. Therefore, the hysteresis of materials used in the prior art can prevent the distal end from properly positioning with the superior esophageal sphincter. The prior art describes the possibility of the distal end entering the larynx, or the distal end of the LMA or SAD potentially folding downwards, a phenomenon described as downward folding. Unlike other LMAs or SADs, the present invention uses an airway tube extending from the proximal end to the distal end, and the form and function of this airway tube utilize the instantaneous viscoelastic response of a rigid polyolefin material. While other SADs describe ventral displacement of the distal end relative to a dorsal or posterior reference point on the airway tube for better anatomical conformation, the present invention provides a wide range of flexible responses that eliminate the ventral displacement described in the prior art.

[0093] A raised step 14 is defined by protruding from the outer surface of the gastric drainage tube opening closest to the adapter (Fig. 16), having a corresponding cut (Fig. 17) or groove 43 in the outer surface of the adapter. This raised step retains and prevents the adapter from separating from the airway tube (Fig. 20).

[0094] When viewed from above towards the far end ( Figure 7 The proximal end 12 of the gastric drainage tube is aligned with the midline plane of the airway tube, meaning the two pathways share the same midline plane. Figure 7 It is important to note that the midline of the airway tube is aligned with the transverse end of the airway tube, not with the main or secondary access route. To provide a main access route with sufficient inner diameter to accommodate both ETT insertion and blind cannulation, the third access route is laterally offset and separated by an impermeable barrier (the posterior surface of the airway tube) to ensure simultaneous blind cannulation and access to the stomach.

[0095] As the central axis of the proximal opening (Fig. 9) approaches the intersection with the central axis 13a of the adapter and the airway tube, the tubular cross-section gradually transitions to an elliptical shape and no longer presents a closed perimeter, having an opening 15 to cross the proximal airway tube. Figure 2 When the gastric drainage aspiration catheter is inserted through the tubular feature 12, the distal end of the aspiration catheter will make tangential contact 16 with the posterior surface of the main passage. Figure 3 Further insertion causes the inhalation catheter to deflect laterally, aiming for alignment with the support structure of the support member (such as rib 17 of the rear passage or third passage adjacent to this area). The inhalation catheter can then be guided internally to exit at the distal end of the device 20.

[0096] Proximally, the intermediate strip is attached by four laterally positioned latches 18 (two on each side), which span the airway duct. Simultaneously, at the cross-section where the airway duct terminates in a transverse straight segment and where curvature 6 begins, the intermediate strip abruptly narrows 19. The support structure of rib 17 follows the curvature of the airway duct 6; the opposing rib 11a (Fig. 6a), integral with the intermediate strip, provides alignment and minimal interference sufficient to provide the aforementioned attachment. Ribs 11a and 17 gradually narrow and terminate proximally at the central groove 8.

[0097] Having described the airway conduit, intermediate strip, and adapter (any one or all of which, in one possible embodiment, can be made of a polyolefin material), the description now focuses on an inflatable cuff made of a thermoplastic elastomer (TPE) composite of the same base polyolefin material. This in itself provides the method of assembly for the device described herein. The self-adhesive properties of the TPE adhere the intermediate strip to the airway conduit and form an open, thin-walled cuff membrane via an initial injection molding process; a subsequent injection molding process traps the open membrane, resulting in an airtight and inflatable cuff that is integral to the form and function of the device.

[0098] Looking forward from the front ( Figure 11 The initial injection molding process is used to create an elliptical TPE cuff membrane that generally surrounds the airway duct around its periphery. In a particular embodiment, the cuff membrane is characterized by: a distal end whose curvature and width favor the tubular distal opening of the third access 20 or gastric drainage duct; a transverse end 21 defined by a curvature extending tangentially above the distal end; an increased rate of curvature that closes the elliptical shape at the midline plane 22, just above the horizontal axis, through two laterally opposed grooves 23; and a closed third access or gastric drainage duct 24 that completely covers the midline groove 9, and whose contour and curvature 31 conform to the contour and curvature of the local posterior channel 5. It should be understood that in alternative embodiments, the membrane can be of various opening shapes, which can allow closure via a second molding process to seal the opening membrane, thereby allowing the cuff to expand.

[0099] Horizontal cross-sections BB and CC (Figs. 13 and 14) show the ventral or anterior opening 7 through which the main and secondary pathways exit. Regarding Fig. 14, the periphery of the ventral opening is defined by a thin-walled, inflatable cuff membrane presenting an elliptical segment 25. It first adheres to the periphery of the distal airway duct 26 and continues tangentially from the immediate anterior portion of the airway duct to its lateral end, orthogonal to the edge of the airway duct. The manufacturing process requires the cuff membrane to open along the posterior opening 27 of the periphery (…). Figure 12(and Figure 14), except for the region surrounding the distal opening of the gastric drainage tube (Figure 13), this region is molded into a closed segment 28 defining the configuration of an inflatable cuff surrounding the distal drainage tube. For this purpose, as a result of the first injection molding step, the inflatable portion or cuff is in the form of an open annular shape having a membrane opening along the annular periphery and adjacent to the periphery of the airway tube.

[0100] refer to Figure 8 The thickness of the airway duct along periphery 26 varies from 1.00 mm at position 26a to 0.5 mm at position 26b, combining with the compound curvature 33 at the distal airway duct to provide a flexible articulation, rather than flexing the distal end around a fixed horizontal axis. The thickness of the inflatable cuff membrane varies between 0.25 mm (the leading edge of the posterior opening 27) and 1.50 mm along the periphery of the distal airway duct 26. All other cuff membrane wall thicknesses are optimized to provide ideal inflation shape and mechanical strength, e.g., the inflatable cuff membrane ( Figure 11 The portion of the small tubular port 29 surrounding the inflatable conduit 29a (Figures 20 and 21) is extruded from thermoplastic elastomer. Figure 24 and Figure 25 It is equipped with an inflatable balloon 29b and a check valve at its proximal end, allowing communication with the inflatable balloon gas.

[0101] In some embodiments, the distal portion of the gastric drainage catheter may not intersect the inflation volume of the cuff (Figures 13 and 14). In this embodiment, the outer diameter may not be directly exposed to the inflation pressure within the inflatable cuff; the wall thickness of the gastric drainage catheter does not require reinforcement to prevent blockage; thus avoiding a spherical distal cuff configuration. Alternatively, and consistent with the closure segment 28, the inflatable cuff membrane 25 is molded into a closed tubular segment 30 concentric with the third access or gastric drainage catheter 24, forming a free space or cavity 32 near the end of the device and between the inflatable membrane and the distal third access, particularly around the opening through which the gastric drainage catheter extends. After placement and inflation, the closure segment 30 of the cuff membrane will not expand to the point of eliminating all free space or cavity 32 and compressing and blocking the gastric drainage catheter 24. Therefore, the free space or cavity 32 provides an expansion buffer, the size of which can be determined by design to accommodate full inflation of the cuff. Therefore, the cuff will inflate to its vicinity, providing support for the third access or gastric drainage tube 24, and the distal opening 20 will abut against the upper esophageal sphincter.

[0102] Furthermore, immediately above the distal opening, the anterior portion of the distal airway tube's composite curvature 33 defines the internal posterior surface of the third access or gastric drainage tube; the narrow width and curvature of the airway tube; the gradually decreasing thickness 26b; and the surrounding contour portion 34 of the self-adhesive TPE elastomer minimize the deflation thickness at the distal end. Now, aided by the softer TPE, the elastic response of the polyolefin airway tube is exhibited at the distal end. This configuration keeps the combined thickness of the materials to a minimum, a feature evident during pre-deployment cuff deflation, eliminating the potential spherical characteristics of the distal cuff and gastric drainage support structure.

[0103] The outline of the TPE, which has defined the closed segment 28 and adheres to the distal anterior airway duct (Fig. 13), advances upward along the progressive curvature 31 of the median groove 9, smoothly fusing the resulting posterior outline 35 into the intermediate strip, where it is positioned against the proximal end 8 of the median groove. At this junction, the TPE makes the intermediate strip ( Figure 7 and Figure 12 The TPE 37 turns to either side, filling the sagittal plane gap 36 defined by the intermediate strip positioned against the posterior curvature of the airway tube 6. Proximally, at the junction of the abruptly narrowing intermediate strip 19, the TPE 37 converges to integrally surround the latch 18 and the intermediate strip, which spans the airway tube; completing the connection between the intermediate strip and the airway tube. Surrounded by the TPE, the sealed connection forms a closed third access or gastric drainage tube with proximal and distal openings.

[0104] The angle of the tubular feature relative to the adapter (Figs. 16 and 17) combined with the elastic properties of the TPE allows the user to: apply a levering action to the tubular feature 12 in direction 40, thereby reducing the angle of incidence through the retaining step 14 relative to the anterior plane (Fig. 9); and remove the adapter to insert an endotracheal tube or endoscope.

[0105] By inserting the distal end into the proximal airway tube opening 42 and pushing it back, the adapter can return to its initial position. Once the slot 43 in the adapter encounters the raised step 14 on the tubular feature 12, a moderate increase in pressure will cause the adapter to quickly return to its original position; the mating surface 44 of the adapter ( Figure 5 The airway tube 1 is pressed in and abuts against TPE 45 to create an airtight seal, which covers the proximal airway tube 1 and the intermediate strip; the cylindrical cutout 46 in the adapter provides a minimum clearance against the tubular feature 12.

[0106] The subsequent injection molding process provides a core and cavity that securely positions the anterior edge of the opening cuff membrane onto airway portions (such as the posterior distal airway duct periphery 26). The TPE interacts with the anterior peripheral edges, trapping them and fusing with the already completed distal closure segment 28, conforming to the final inflatable cuff profile defined by the injection-molded core and cavity to close the annular cuff. Another embodiment of this interaction ( Figure 12 This causes the TPE to be further intercepted at the leading edge through the small incision 47 and directly adhered to the posterior part of the distal airway tube.

[0107] The final outline of the distal portion ( Figure 18 Figure 20 and Figure 22 Additional TPE was added to the initial rear profile 35 of the airway tube, wrapping around the airway tube and completing the sealing perimeter 48 of the airway tube; thus forming an airtight inflatable cuff. Another embodiment of this perimeter fusion ( Figure 19 Figure 21 and Figure 23 The step portion 49 gradually tapers to form a smooth fusion portion 50 around the perimeter of the airway duct.

[0108] The completion of the inflatable sheath membrane concludes the manufacture of the device described in this invention, requiring no adhesives or solvents. The use of entirely polyolefin-based materials provides a more eco-sustainable alternative to PVC and vinyl elastomers or LSRs, which may contain DEHP plasticizers, and LSRs cannot be recycled or similarly reprocessed because they are thermosetting materials with irreversible crosslinking during the molding process.

[0109] According to another aspect of this disclosure, and with reference to Figures 26-34 In some embodiments, the body 6 may comprise a thin wall molded from a primary polypropylene random copolymer blended with a small amount of SEBS, where the SEBS forms a dispersed elastomeric phase within the polypropylene (Abreu FOMS, Forte MMC, Liberman SA. SBS and SEBS block copolymers as impact modifiers for polypropylene compounds, Journal of Applied Polymer Science, Vol. 95, 254-263 (2005)). When discussing the mechanical structure of the body as a lever, this thin-walled molded component is hereby interchangeably referred to as the shell; when referring to the function of the body 6 as a breathing duct or passage, this thin-walled molded component is interchangeably referred to as an airway duct.

[0110] Specifically, according to one embodiment, the initial rear profile 35 may include SEBS overmolded onto the outer shell, which flows into the cuff membrane 25 to form an inflatable cuff. Due to their mutual solubility, the SEBS diffuses into the polypropylene, and similarly, the polypropylene diffuses into the SEBS, creating an entangled intermediate phase of polypropylene and SEBS along the periphery of the distal airway duct 26, producing a first opposing edge. Simultaneously, a straight portion is overmolded to the proximal end 37, such that the curved or initial rear profile 35 and the straight portion 37 are combined into a single molded piece using sealing gaps 36 on the left and right sides of the intermediate strip 38. The first overmolding is completed without using adhesives to bond or weld discrete components, followed by a second SEBS overmolding to seal the rear opening periphery 27 or the second opposing edge of the cuff membrane 25. The second overmolded portion covers the initial rear profile 35 with additional SEBS, closing and sealing the cuff membrane with a sealing periphery 48. As described above, the main body 6 has been effectively "assembled in the molding section" using three separate injection molding processes, and all the required fluid communication channels and inflatable bladders are now complete.

[0111] like Figure 33 As shown, the inflatable cuff is used to seal the upper esophageal sphincter 70, but when the distal end 2 of the body 6 is wedged into the upper esophageal sphincter 70, the distal portion of the inflatable cuff must include a mechanism to reduce compression of the glottic inlet along the anterior-posterior axis. Figure 29 A cross-section through the distal end 2 is shown. The distal rear profile 34 of the distal end 2 covers the composite curvature 33 of the molded housing. The TPE-covered molded distal profile 34 extends upward and merges with the distal periphery of the initial rear profile 35 and the housing or the first opposing edge 26. This extended or closed segment 28 ( Figure 26 The cross-section (CC) completes the covering molding of the distal portion of the third access or gastric drainage tube 24. The anterior portion of this compound curvature 33 defines the inner diameter and route of the gastric drainage tube 24; terminating at the distal opening 20. As the distal posterior contour portion 34 and the closing segment 28 are positioned and pressed against the laryngopharynx 74, this distal portion is subjected to increased esophageal pressure 71 ( Figure 34 The upward displacement is prevented by the distal to proximal full-length configuration and anatomical curvature of the pharyngeal body 6. The softer distal posterior contour 34 and distal opening 20 wedge into the superior esophageal sphincter, maintaining an effective esophageal seal.

[0112] During cuff inflation, the gastric drainage tube 24 and its distal opening 20 will not shift anteriorly because they are integral with the distal posterior contour 34 pressed against the laryngopharynx 74; that is, the third access or gastric drainage tube 24 will not be inflated by the cuff. Figure 29The annular volume surrounds the gastric drainage tube 24, and with this in mind, no expansion-enhancing inflatable cuff is needed to prevent obstruction. Only the distal portion of the cuff membrane, molded to be concentric with the closed segment 30, is displaced anteriorly. The cavity 32 formed by the closed segment 30 provides space for the distal portion 30 to accommodate the anatomical structure that shifts posteriorly upon inflation, rather than pushing the glottis 66 anteriorly.

[0113] In this embodiment, the non-inflatable volume of the pharyngeal body 6 is reduced because the required elasticity and flexural response are provided by a thin-walled shell, rather than by an assembly consisting of multiple parts with different stiffness and thickness. All closely adjacent points (or gaps between all points) of the periphery of the distal airway duct 26, orthogonal to the leading edge (or the first and second opposing edges, respectively) of the cuff membrane 27, which depicts the opening, are closed by a second overlay molding to create an inflatable cuff. The cuff is sealed posteriorly against the laryngopharynx 74 and anteriorly against the laryngeal inlet 65 by a single inflatable membrane 25, without any adhesive joints. Figure 30 This effectively maximizes the surface area of ​​the inflatable cuff and minimizes the contact between the non-inflatable surface (the surface without elastic recoil) and anatomical structures, thereby minimizing the direct compression of neural structures by the non-inflatable surface.

[0114] Nerve injury is multifactorial, with inflatable cuffs being a significant contributing factor. Inflatable cuffs are either too rigid during insertion or directly compress neural structures upon placement. A cuff membrane 25, encapsulating the molded structure and integral with the body 6, exhibits resilience and measurable elasticity during insertion. The cuff membrane can be deflated to present a flattened wedge shape, facilitating insertion between teeth, through the tongue, and across the palatoglossal arch. For a given tension, the ability of SEBS to stretch or elongate beyond its original length is limited by the relative amounts of hard and soft domains within the individual polymer bundles; upon inflation, the soft domains provide elasticity and conform to the anatomy, while the hard domains ensure resilience and conformity to the molded shape. LSR or PVC elastomers with single domains tend to expand anterolaterally upon encountering anterior and posterior resistance, losing their molded shape and compressing neural structures such as the lingual and hypoglossal nerves.

[0115] Cross-section BB through the lateral cuff Figure 30 This reveals an under-square relationship between height 51 and width 52, meaning the height is always greater than the width. At low inflation pressures or when the pressure inside and outside the cuff 25 is equal, this under-square relationship, combined with the cuff 25 maintaining its molded shape, produces an initial anatomical seal. After inflation 25a, the same under-square relationship is maintained, ensuring reduced anterolateral expansion of the cuff.

[0116] refer to Figure 26 The curvature of each lateral end or curved periphery 21 converges tangentially at its intersection with the midline plane 22. Both lateral portions of the cuff 53 are fused into the proximal portion 54, and the ventral opening 7 is rectangularly configured, wherein each fused portion 55 is an arc with an equal radius; respectively Figure 28 The inner radius 56 of the first passage and the radius 57 of the secondary passage are shown as continuations. A line 58 passing through the center of each radius fusion section 55 at 70 degrees on either side of section AA creates a vertical angle of 140 degrees. Figure 26 and Figure 27 The cross-section FF is a planar cross-section passing through line 58. The closed two-dimensional cross-sectional area of ​​the sheath membrane 25 is the smallest of all other non-square cross-sections passing through the sheath membrane. During inflation ( Figure 27 The two transverse portions 53 and the proximal portion 54 expand, pressing against each other at this section FF so that each fusion portion 55 becomes a fold 59, and retains the ventral opening 7 in the first small hole. This restricts the over-inflation of the proximal portion of the inflatable cuff 25 against the base of the tongue 75; the proximal portion of the inflatable cuff 25 remains aligned with and presses against the end of the epiglottis 76. Figure 33 and Figure 34 ).

[0117] When the patient is in a backward position ( Figure 34 When inserting an endotracheal tube (ETT) 61, the distal end 62 needs to exit the ventral opening 7, pass through the laryngeal inlet 65, and be aligned with the glottis 66. As the ETT 61 continues to descend through the glottis, the distal end 62 of the ETT 61 must be correctly aligned with the trachea 68. Figure 33 and Figure 34 In general, the length of the airway tube from the proximal opening 42 to the ventral opening 7 should be kept to a minimum so that the distal end 62 of the ETT can be positioned sufficiently below the glottis 66. To facilitate meeting this minimum requirement, pressure is applied above the tubular port 12 to release the raised step portion 14 of the retaining connector 39. Figures 31-33 ).

[0118] The most efficient pathway or catheter for intubation and gastric drainage occupies the same anatomical space between the ventral opening 7 and the proximal opening of the combined main and secondary pathways 42. Their relative relationship contributes to the overall volume of the device. Due to the limited available space in the oropharynx 73, and to avoid pressure nerve injury from the body 6, an anatomically approximate curvature is used, wherein the first or main pathway 3, occupying the space closest to the midline plane 22 of the body 6, is preferred, although slightly offset from said midline plane ( Figure 28 ).

[0119] The third access for gastric drainage is symmetrically opposite and parallel to the first access 3, with the planar void 36 on either side of the intermediate strip 38 defining this offset. The third access for gastric drainage does not merely occupy the internal space of the airway tube, but is a structural component; that is, it contributes to the overall flexural strength of the shell of the body 6, allowing for minimal wall thickness of the main access 3, thereby facilitating maximum internal space for insertion. The SEBS filling the planar void 36 creates an entangled intermediate phase of polypropylene and SEBS along the entire length of the anatomical curvature depicted by the support rib 17 and the intermediate strip 38. During insertion, the bending and elongation applied to the proximal end of the body 6 are dissipated as shear and absorbed by the aforementioned intermediate phase of the intermediate strip 38 incorporated into the body 6.

[0120] The combined width of the body 6 can be symmetrical about the central plane 22. The nominal wall thickness of the housing (e.g., 1.00 mm) reduces the overall volume and maximizes the inner diameter of the first passage 3, achieving a typical inner diameter of 8.5 mm for an adult ETT 61 in a size 4 device. The removable connector / adapter 39 reduces the length from the proximal opening 42 of the body 6 to the trachea 68, providing additional insertion depth for the ETT 61.

[0121] If an ETT 61, comprising a semi-rigid curved PVC tube, is inserted into the proximal opening of the body 42, with the curvature of the tube oriented as if using a laryngoscope (the ETT curvature follows anatomical curvature), the exit trajectory of the distal end 63 of the ETT upon entering the laryngeal inlet 65 will point towards the thyroid cartilage 69, not the glottis 66. However, by grasping the receiving tube 12 and lifting the proximal opening 42 of the body 6 forward, the exit trajectory of the distal end 63 of the ETT from the first passage 3 through the ventral opening 7 and into the laryngeal inlet 65 can be optimized. Figure 34 As shown, the distal end 61 of the ETT 62 can exit the ventral opening 7 and enter the laryngeal inlet 65, which is more closely aligned with the trachea 68. Since the ETT is primarily made of PVC, and PVC is characterized by a sticky polymer, the force required to bend the ETT shaft 61 through the main passage or first passage 3 creates a curvature with an equivalent radius smaller than the predetermined curvature of the ETT shaft 61. The energy required to bend the ETT shaft 61 is dissipated into the length of the shaft and extends through its length. When the distal end 63 of the ETT exits the ventral opening 7, the extended distal end 63, including the balloon 62, attempts to return to its original curvature. However, this return is not immediate.

[0122] This energy loss or delayed recovery facilitates the alignment of the distal tip 63 with the glottis 66. As the distal tip 63 of the ETT further enters the larynx, the lost energy is recovered, allowing partial straightening of the axis of the ETT 61. During recovery, the body 6 can be lifted forward by grasping the receiving tube 12 to align the distal tip 63 of the ETT with the glottis 66. The ETT 61 is then further inserted; the distal tip 63 passes through the vocal cords 67 and enters the trachea 68. The connector / adapter 64 is then removed from the tubular axis of the ETT 61. The inflatable cuff 25 is deflated, and the body 6 is removed, leaving the inflatable cuff in place. The ETT connector / adapter 64 is then returned to its previous position. The viscous properties of the ETT catheter body enable gradual and damage-free recovery of curvature.

[0123] According to another aspect of this disclosure, a manufacturing method is also disclosed. As background, conventional injection molds include a core that typically defines a recess or interior portion of the molded part and a cavity that defines a protrusion or exterior portion of the molded part. Molten polymer is injected into the mold via a single screw / plunger mechanism. As the polymer is allowed to cool and solidify, it shrinks onto the core and is removed from it. A second screw mechanism can be added, allowing polymers of two different colors or two different polymers to be injected sequentially into the mold in most cases.

[0124] The essential mold feature lies in the complexity of molding the initial part with a first polymer; then, the core is rotated via some kind of containment mechanism to overmold with a second polymer. Typically, the two cores are identical, but the corresponding cavities are different; the first cavity describes the geometry of the base or foundation part, and the second cavity describes the final overmolded portion. Referring to multi-part molding, it is also possible to introduce and overmold parts that are separate from the process, thus extending the definition to in-mold assembly. Technically, the application of this approach is limited to relatively small prismatic parts and sub-assemblies, as the application is confined to the physical constraints of a single injection molding machine. This complexity of sequentially interacting molds can be described as a rigid body system where each mold requires kinematic constraints; that is, the interaction between the core and cavity of each mold group is a prismatic pair with a single degree of freedom (mold opening and closing), and the interaction between subsequent processes within the molding machine frame is a pair (when the mold opens, the core rotates to the next cavity). Both constraints are characterized by a single degree of freedom.

[0125] In the above embodiments, the synthesis of design features is achieved through mold cores, which reduces the feature volume of the distal end, reduces compression of the glottic inlet along the anterior-posterior axis, reduces the risk of nerve damage, and defines the non-square relationship of the inflatable sheath membrane 25. Each core is a rigid body, and these cores together form a rigid body system. (Reference) Figures 35 to 45The fixed frame 90 is a constrained rigid body. Each mold core is joined, aligned, or linked to the fixed frame 90 via kinematic pairs or mechanisms. Each kinematic pair refers to the kinematic constraint between each pair of rigid bodies that restricts the movement of one rigid body relative to another. Constraints are planar or spatial degrees of freedom (DOF), i.e., linear or rotational displacement. An unconstrained rigid body has linear displacement on 3 axes and rotational displacement on each of these axes; a total of 6 DOFs. The total displacement of the kinematic pairs is sufficient to remove the completed body 6 from the rigid body system (hereinafter referred to as the system).

[0126] The main body 6 is not conceived as a simple solid primitive displaying symmetry; the free geometric complexity of the pathways or fluid paths within the main body 6 requires the mold core to be capable of linear and rotational displacements and combinations thereof, ranging from one DOF to six DOFs. It is this complexity that distinguishes it from multi-part molding or in-mold assembly. Instead of in-mold assembly using a single injection molding machine, the main body 6 is manufactured by transferring the system through a series of injection molding machines. In this embodiment, three injection molding machines (processes) are required. The outer shell is the initial base or base component (first injection molding process), the initial rear contour 35, the sagittal plane void 36 together with the intermediate strip 38, and the straight portion 37 constitute the first encapsulation molding portion (second injection molding process). Subsequently, the initial rear contour 35 and the plane void 36 become the base, and the sealed perimeter 48 constitutes the second encapsulation molding portion (third injection molding process).

[0127] In mold assembly, the degrees of freedom associated with mold configuration are restricted, thus limiting the complexity of the molded part and resulting in a very complex injection molding process. To achieve the aforementioned design synthesis, the fixed frame 90 must be removable and transferable between injection molding machines, and itself facilitate precise interlocking in each injection molding process. Subsequently, additional components can be introduced within the space between the molding machines, adding, removing, or shifting molding cores via linear or rotational displacement or a combination thereof, without the kinematic constraints inherent in the physical dimensions of any single molding machine. The fixed frame 90 serves as the reference for all processes until the completed assembly is removed from the fixed frame 90 using a demolding mechanism. Essentially, the body 6 is assembled through the transfer of the system between injection molding and non-injection molding processes, each step of which is either an injection molding process or in-mold assembly. The non-injection molding process allows for the manipulation of the system mechanism and the introduction of external components using a larger DOF than in-mold assembly.

[0128] from Figure 35 and Figure 36Initially, the first rotating core 91 is a revolute joint constrained by a first pivot 97. The revolute joint follows a single DOF that allows the first rotating core 91 to rotate about an axis defined by the first pivot 97. Similarly, the second rotating core 92 is a revolute joint constrained by a second pivot 98. The proximal core 94 is a pair of prisms that allow linear displacement in one direction and provides a single DOF through a sliding mechanism shared with the fixed frame 90.

[0129] At the start of the manufacturing process, and as Figure 35 and Figure 36 As shown, a rigid body system is placed into a first injection mold to mold the outer shell. At this time, the rigid body system is in static equilibrium. The first rotating core 91 is constrained by a pivot 97, and its rotation is defined by a proximal core 94 and a second rotating core 92. The position of the second rotating core 92 is fixed by a retainer, which may include an angled surface on a pivot 98 abutting a leaf spring 103. When manually lifted by a handle 104, the mass of the system is supported by the proximal core 94 supporting the first rotating core 91, which in turn supports the second rotating core 92, which is fixed by an angled surface on a second pivot 98 supporting the leaf spring 103.

[0130] Figure 37 shows the housing molded onto the first rotating core 91 and the proximal core 94. After the system is removed from the first mold and before it is placed in the second injection mold (the second injection molding process is the first overmolding), the second rotating core 92 rotates to the position shown in Figure 38 by releasing the leaf spring 103. The distal core pin 93 is also introduced as a rigid body that is unrestricted relative to the fixed frame 90. This distal core pin 93 is fitted into the inclined channel 105 in the fixed frame 90 and locked in place. Note the support rib 17 that positions the intermediate strip 38.

[0131] Figure 39 illustrates the orientation of the intermediate strip 38 attached to the housing. The latch 18 helps secure the intermediate strip 38 to the housing. Since the effective paths for cannulation and gastric drainage occupy the same space, cannulation takes priority, and a portion of the third passage 5 (the intermediate portion of the third passage or gastric drainage catheter 24) is offset through the intermediate portion of the body. At the proximal and distal ends of the third passage, the tubular port 12 and distal ends 26a / b of the housing are realigned with the central axis. This realignment and angular configuration of the tubular port 12 relative to the partial posterior passage 5 prevents the use of a molded core, as there is no tool for removing the molded core. Furthermore, the intermediate strip 38 is uniquely characterized by its overmolded design, with no tools, except for the support ribs 17, to resist deformation caused by the heat and pressure of injection molding.

[0132] The system is placed into a second injection mold for the first overmolding. Unconstrained rigid bodies, such as the first removable core 95 and the second removable core 96, are also placed in the second injection mold. Figure 41 As shown, the closing of the mold positions the removable cores 95 and 96 near the first rotating core 91 and the second rotating core 92. Figure 42 The subsequent overmolding of the shell is shown, resulting in a complete body 6 with a central stripe 38, an inflatable sheath 25, planar voids 36, and straight sections 37. Note the rear opening 27 of the sheath 25. The system is then removed from the second injection mold.

[0133] When the first removable core 95 and the second removable core 96 are overmolded with a material such as SEBS (forming a sheath membrane 25), they are initially constrained by the membrane. These removable cores 95 and 96 are unconstrained rigid bodies relative to the fixed frame 90, by utilizing… Figure 43 The six-degree-of-freedom external mechanism shown is removed through the opening sheath membrane.

[0134] Subsequently, the system is transferred to a third injection mold, in which the open sheath membrane 25 closes against the initial rear profile 35 and is then overmolded to produce Figure 44 The sealing perimeters 48 and 49 are shown. Figures 18 to 22 Other embodiments of this sealing perimeter are shown. This sealing perimeter is a second overmolding section. Further embodiments are not limited by the number of additional overmolding processes because the assembly in the mold is assembled through a series of molding processes in a separate injection molding machine, rather than in a mold assembly, meaning multiple molds in a single injection molding machine. The system can be transferred to the second process without motion constraints.

[0135] As mentioned above, the unique feature of the intermediate strip 38 is that it is overmolded without any tools to resist deformation caused by the heat and pressure of injection molding. To illustrate, Figure 44 The intermediate arc 106 shown represents the intermediate arc segment of the body 6. The intermediate arc segment 2X is common to any plane perpendicular to the point along the intermediate arc and the center point of the equivalent radius of the intermediate arc 106. The inner concavity or diameter of the intermediate strip 38 is the same as the cross-sectional diameter of the local rear channel 5 in the body 6; each intermediate arc segment passing through the intermediate strip 38 represents a beam with simple support. During overmolding, the sagittal plane void 36 is filled with a material such as SEBS. The outer edge of the intermediate strip 38 parallel to the sagittal plane void 36 gradually tapers to a fine edge 38a. Figure 44As shown in the magnified section 6X, these fine edges 38a act as a protective shield for the support rib 17. As a sacrifice, heat from the first overmolding process melts the fine edges 38a of the polypropylene intermediate strip 38, diffusing it into the SEBS that fills the sagittal plane voids 36. Furthermore, the pressure against the fine edges 38a presses them against the support rib 17, further sealing the third passage. The fine edges 38a also increase the surface area of ​​the overmolding process for better fixation of the intermediate strip 38.

[0136] Finally, in order to remove the completed body 6 from the fixed frame 90, the individual cores defining each channel or fluid path are functionally displaced along a finite path relative to the fixed frame 90, which remains stationary. Figure 45 In the process, the first rotating core 91 rotates 90 degrees, and the proximal core 94 linearly displaces to release the proximal end of the body 6. The distal core pin 93 is initially constrained by a planar molded material. The distal core pin 93 is surface-treated to reduce friction so that it can be transformed into an unconstrained rigid body when removed from the body 6. Finally, the body 6 remains attached to the second rotating core 92, the dynamic constraint being a cylindrical pair. Rotation of a portion of the defined closed tubular segment 30 about the second rotating core 92 and linear displacement along the axis of the tubular segment 30 allow for the removal of the complete body. The constrained rigid body returns to Figure 35 The described configuration is then repeated.

[0137] In this embodiment, the assembly in the mold is a motion synthesis of channels or fluid paths, wherein the channels are designed to be functionally independent and combined with each other, and structurally dependent on each other as a whole.

[0138] As described, this synthesis is a combination of material compatibility, design features, and unique manufacturing methods.

[0139]

[0140]

[0141]

[0142]

[0143]

[0144] This disclosure may be considered to be related to any or all of the foregoing entries in any combination:

[0145] 1. An airway management device, comprising:

[0146] The body (6) comprises a shell molded from a polypropylene copolymer (PP) blended with thermoplastic elastomer (TPE) styrene-ethylene / butene-styrene (SEBS), the shell extending from a proximal opening of the body (6) to a distal end, the shell having a curved portion (35) and a straight portion (37).

[0147] 2. The airway management device according to item 1 further includes an intermediate strip (38) molded from polypropylene copolymer (PP), the intermediate strip (38) being attached to the housing at the midpoint between the curved portion (35) and the straight portion (37).

[0148] 3. The airway management device according to item 1 or item 2 further includes a first SEBS covering molding portion, the first covering molding portion including a rear profile portion (35) and a distal profile portion (34) on the housing.

[0149] 4. The airway management device according to any one of items 1-3, wherein the first covered molding portion or the first covered molding portion includes a distal periphery (26) defining a first opposing edge of a covered molding cuff membrane (25), the covered molding cuff membrane (25) extending tangentially from the periphery (26) in an annular curve, the endpoints of the annular curve being spaced apart from and orthogonal to the first opposing edge, the endpoints defining a rear opening portion (27) periphery or a second opposing edge and a straight portion (37) covering the molded proximal end, such that the curved portion (35) and the straight portion (37) are combined into a single molded part by planar sealing gaps (36) on the first and second sides of an intermediate strip (38).

[0150] 5. The airway management device according to any one of items 1-4, further comprising a second SEBS covering molding portion, the second covering molding portion closing the opening length (27) of the membrane to form an inflatable cuff.

[0151] 6. An airway management device according to any one of items 1-5, wherein the rear profile portion (35) of the body (6) or the rear profile portion (35) is adapted to be located in the laryngopharynx, and the distal end (2) is adapted to be located in the upper esophageal sphincter, wherein an esophageal seal is formed immediately above the distal opening (20), and the anterior composite curvature (33) of the housing is the internal posterior surface of the channel or gastric drainage tube (24), thereby reducing the volume of the distal end (2).

[0152] 7. The airway management device according to any one of items 1-6 further includes a surrounding contour (34) that covers the front composite curvature (33) of the housing and is adapted to be positioned and pressed against the laryngopharynx, the full-length configuration of the housing from distal to proximal providing resistance to upward displacement of the distal opening (20) due to increased esophageal pressure (70).

[0153] 8. The airway management device according to any one of items 1-7, wherein the drainage conduit (24) or the drainage conduit (24) and the distal opening (20) of the drainage conduit are integral with the distal posterior profile (34), and wherein the drainage conduit (24) is not surrounded by the annular volume of the inflatable cuff.

[0154] 9. The airway management device according to any one of items 1-8 further includes a closed tubular segment (30) forming a cavity (32) to provide space for the distal portion of the inflatable bladder that is displaced rearward during inflation.

[0155] 10. An airway management device according to any one of items 1-9, wherein, through any horizontal cross-section of the inflatable cuff, at least for the length of the distal portion of the gastric drainage tube (31), the first edge and the second edge (27) remain parallel to the midplane (10) of the curved portion (35), such that, after a second overmolding, the width between the first edge and the second edge (27) is equal to the outer diameter of the distal drainage tube (31).

[0156] 11. The airway management device according to any one of items 1-10, wherein the curvature of the inflatable sheath membrane (25) between the first opposing edge (26) and the second opposing edge (27) is a single continuous curvature with uniformly indicated stiffness, thereby sealing posteriorly against the laryngopharynx and anteriorly against the laryngeal inlet without having an adhesive joint.

[0157] 12. A method of using an airway management device according to any one of items 1-11, comprising:

[0158] A removable connector / adapter (39) is provided on the straight portion to reduce the length from the proximal opening (42) of the body (6) to the trachea (68), thereby providing additional insertion depth of the distal end (63) of the endotracheal tube.

[0159] 13. A method of using the airway management device according to any one of items 1-11, comprising:

[0160] A finger stopper (60) is provided, which forms a fixed position for resting the thumb during insertion, to grip the proximal end (37) when the device is removed after insertion, and to serve as a depth indicator for reference teeth when the device is in place.

[0161] 14. A method of forming an airway management device, comprising:

[0162] Provided a body (6) comprising a polypropylene copolymer (PP) and a thermoplastic elastomer (TPE) styrene-ethylene / butene-styrene (SEBS), said body (6) comprising a shell molded from a primary PP copolymer blended with SEBS, said shell extending from a proximal opening of said body (6) to a distal end.

[0163] 15. The method according to item 14 further includes the step of:

[0164] An intermediate strip (38) molded from a polypropylene copolymer is attached to the outer shell between the curved portion (35) and the straight portion (37) of the body (6).

[0165] 16. The method according to item 14 or item 15 further includes the step of:

[0166] A first SEBS overmolded portion is provided, the first overmolded portion including an initial rear profile (35) and a distal profile (34) overmolded onto the housing, the distal periphery (26) of the first overmolded portion defining a first opposing edge of an overmolded sheath membrane (25), the overmolded sheath membrane (25) extending tangentially from the distal periphery (26) in an annular curve, the endpoints of the annular curve being spaced apart from and orthogonal to the first opposing edge, the endpoints jointly defining a periphery of a rear opening (27) or a second opposing edge and a straight portion overmolding the proximal end (37), such that the curved portion (35) and the straight portion (37) are combined into a single molded part through planar sealing gaps (36) on both sides of the intermediate strip (38).

[0167] 17. The method according to item 16 further includes the step of:

[0168] A second SEBS-coated molding portion is provided to close the membrane (25), thereby forming an inflatable bladder and completing the body (6).

[0169] 18. A method of forming an object, comprising:

[0170] The first part of the object is injection molded onto the first core associated with the fixing device;

[0171] After injection molding the first portion, the second core associated with the fixing device is moved to the deployment position; and

[0172] The second part of the object is injection molded onto the second core and the first part.

[0173] 19. The method according to entry 18, wherein the step of moving the second core associated with the fixing device to the deployment position includes rotating the second core relative to the fixing device.

[0174] 20. The method according to item 18 or item 19 further includes the step of:

[0175] Attach the pre-formed part to the object;

[0176] Place one or more removable cores into the object; and

[0177] Before molding the second portion of the object, one or more removable cores are placed within the injection mold; and

[0178] The film is used to coat the second part of the object.

[0179] 21. The method according to any one of items 18-20 further includes the step of injection molding to close and seal a third portion of the membrane to form an inflatable portion of the object.

[0180] 22. The method according to any one of items 18-21 further includes the step of removing the removable core from the film of the object prior to injection molding the third portion.

[0181] 23. The method according to any one of items 18-21, wherein:

[0182] The injection molding of the first portion is performed in a first mold including the fixing device; and

[0183] The injection molding of the second part is performed in a second mold including the fixing device; and

[0184] The step of injection molding to close and seal the third portion of the membrane is performed in a third mold including the fixing device.

[0185] 24. The method according to any one of items 18-23 further includes the step of transferring the fixing device from the first mold to the second mold between the steps of injection molding the first portion and the second portion of the object.

[0186] 25. The method according to any one of items 18-24, wherein the step of injection molding the first portion of the object onto the first core associated with the fixing device includes forming the outer shell of the object.

[0187] 26. The method according to any one of items 18-25, further comprising the step of:

[0188] Move the first core to release the proximal end of the object; and

[0189] Remove the object from the second core of the fixing device.

[0190] 27. The method according to any one of items 18-26 further includes the step of:

[0191] Provides a body comprising polypropylene copolymer (PP) and thermoplastic elastomer (TPE) styrene-ethylene / butene-styrene (SEBS), and

[0192] The first portion includes a shell molded during the first injection molding step from a primary PP copolymer blended with SEBS, the shell extending from a proximal opening of the body to a distal end.

[0193] 28. The method according to any one of items 18-27, wherein the object includes an airway management device.

[0194] 29. An apparatus for forming injection-molded objects, comprising:

[0195] A reconfigurable fixing device including a first movable core and a second movable core, wherein a first portion of the injection-molded object is formed on the first movable core and a second portion of the injection-molded object is formed on the second movable core.

[0196] 30. The device according to item 29, wherein the first movable core is adapted to rotate relative to the fixed device.

[0197] 31. The device according to item 29 or item 30, wherein the second movable core is adapted to rotate relative to the fixing device.

[0198] 32. The device according to any one of items 29-31 further includes a first removable core suitable for removably attaching to said fixing device.

[0199] 33. The device according to item 32, wherein the first removable core includes a connector for connection to the fixing device.

[0200] 34. The device according to item 32, wherein the first removable core includes a handle.

[0201] 35. The device according to any one of items 29-34, wherein the fixing device includes a spring for holding the second movable core in the deployment position.

[0202] 36. A method for manufacturing an airway management device, comprising:

[0203] A tubular body having straight and curved portions is provided, the tubular body including a plurality of supports adjacent to a rear channel;

[0204] Provides a central strip that engages with the plurality of supports and is positioned above the rear channel; and

[0205] The material is molded onto the intermediate strip.

[0206] 37. The method according to item 36 further includes the step of:

[0207] The first part of the body of the airway management device is injection molded on the first core associated with the fixing device;

[0208] After injection molding the first portion, the second core associated with the fixing device is moved to the deployment position; and

[0209] The second part of the body is injection molded onto the second core and the first part of the body.

[0210] 38. The method according to item 37, wherein the step of moving the second core associated with the fixing device to the deployment position includes rotating the second core relative to the fixing device.

[0211] 39. The method according to any one of items 36-38 further includes the step of:

[0212] One or more removable cores are placed in the tubular body;

[0213] Place one or more removable cores within the second injection mold; and

[0214] The removable core is molded by covering it with a film that is part of the second part of the main body.

[0215] 40. The method according to item 39 further includes the step of:

[0216] Remove the removable core from close proximity to the first core and the second core, leaving an open membrane; and

[0217] The second portion is molded by covering the third portion of the membrane with a closed and sealed portion to form an inflatable bladder on the tubular body.

[0218] 41. The method according to item 39 or item 40 further includes the step of moving the first core and removing the removable core to release the tubular body.

[0219] 42. The method according to any one of items 36-41 further includes the step of:

[0220] The first material is placed in one or more gaps adjacent to the intermediate strip containing the first material; and

[0221] Melting includes a portion of the intermediate strip of the second material in order to diffuse the first material into the second material.

[0222] 43. A method of forming an object, comprising:

[0223] In a first injection mold, a first portion of the object is injection molded onto a first core associated with a fixing device;

[0224] Place the fixing device in the second injection mold; and

[0225] Injection molding is used to create the second part of the object.

[0226] 44. The method according to item 43, wherein the first core is movable relative to the fixing device, and further comprising the step of moving the first core after injection molding the first portion or the second portion of the object.

[0227] 45. The method according to item 43 or 44, wherein the step of injection molding the second portion of the object includes injection molding on a second core associated with the fixing device.

[0228] 46. ​​The method according to any one of items 43-45, wherein the second core is movable relative to the fixing device, and further comprising the step of moving the second core to a deployment position after the step of injection molding the first portion of the object and before the step of injection molding the second portion of the object.

[0229] 47. The method according to any one of items 43-46 further includes the step of placing one or more removable cores within the second injection mold prior to the step of injection molding the second portion of the object.

[0230] 48. The method according to any one of items 43-47, wherein the step of injection molding the second portion of the object comprises overmolding a film onto the one or more removable cores.

[0231] 49. The method according to any one of items 43-48, wherein the one or more removable cores are removed from the second injection mold together with the fixing device.

[0232] 50. The method according to any one of items 43-49, wherein the one or more removable cores are removed from the film after injection molding the second portion of the object and before injection molding the third portion of the object.

[0233] 51. The method according to item 50 further includes the step of closing and sealing the membrane to form an inflatable portion of the object.

[0234] 52. An airway management device formed by the method according to any one of items 36-51.

[0235] As used herein, each of the following terms, written in the singular grammatical form “a,” “an,” and “the,” means “at least one” or “one or more.” The phrase “one or more” as used herein does not alter this intended meaning of “a,” “an,” or “the.” Therefore, as used herein, the terms “a,” “an,” and “the” may also refer to and include multiple stated entities or objects, unless otherwise specifically defined or stated herein, or the context clearly indicates otherwise. For example, as used herein, the phrases “unit,” “device,” “component,” “mechanism,” “part,” “element,” and “step or process” may also refer to and include multiple units, multiple devices, multiple components, multiple mechanisms, multiple parts, multiple elements, and multiple steps or processes, respectively.

[0236] As used herein, each of the following terms—"comprising," "including," "having," "having," and "containing," as well as their linguistic / grammatical variations, derivatives, and / or affixes—means "including but not limited to" and is considered to specify the said component, feature, characteristic, parameter, integer, or step, without excluding the addition of one or more additional components, features, characteristics, parameters, integers, steps, or combinations thereof. Each of the following terms is considered to be semantically equivalent to the phrase "substantially composed of." As used herein, each of the phrases "composed of" and "consisting of" means "including and limited to." The phrase “consistent essentially of” means that the stated entity or item (system, system unit, system subunit device, component, subcomponent, mechanism, structure, part or element, peripheral equipment, accessory or material, method or process, step or process, substep or subprocess) is an integral or part of an exemplary embodiment of the disclosed invention and / or an exemplary embodiment for implementing the disclosed invention, and may include at least one additional feature or characteristic: system unit, system subunit device, component, subcomponent, mechanism, structure, part or element, peripheral equipment, accessory or material, step or process, substep or subprocess, but only if each such additional feature or characteristic “does not substantially alter the essential novelty and inventiveness or particular technical features of the claimed item”.

[0237] As used herein, the term "method" refers to steps, processes, manners, means, and / or techniques for accomplishing a given task, including but not limited to those steps, processes, manners, means, and / or techniques known to or readily developed from known steps, processes, manners, means, and / or techniques known to those skilled in the art of the relevant field of the disclosed invention.

[0238] As used herein, approximate terms (such as approximately, substantially, approximately, roughly, etc.) refer to ±10% of the stated value or as close as possible to the stated condition.

[0239] It should be fully understood that, for clarity, certain aspects, features, and characteristics of the invention that are illustratively described and presented in the context or arrangement of multiple individual embodiments may also be illustratively described and presented in the context or arrangement of a single embodiment in any suitable combination or sub-combination. Conversely, various aspects, features, and characteristics of the invention that are illustratively described and presented in the context or arrangement of a single embodiment in combination or sub-combination may also be illustratively described and presented in the context or arrangement of multiple individual embodiments.

[0240] Although the invention has been described and presented illustratively by way of specific exemplary embodiments and examples, it will be apparent to those skilled in the art that many substitutions, modifications, and / or variations of the invention will be apparent. Therefore, all such substitutions, modifications, and / or variations fall within the spirit of the appended claims and are covered by the broad scope of the appended claims.

Claims

1. An airway management device, comprising: The body comprises an injection-molded shell of PP blended with SEBS of TPE, the shell extending from a proximal opening to a distal end of the body, the shell having a curved portion and a straight portion; SEBS first overmolded portion, the first overmolded portion including a rear profile portion and a distal profile portion on the housing, the first overmolded portion also including a distal periphery, the distal periphery defining a first opposing edge of the overmolded opening sheath membrane, the overmolded sheath membrane extending tangentially from the distal periphery in an annular curve, the endpoint of the annular curve being spaced apart from and orthogonal to the first opposing edge, the endpoint defining a second opposing edge; The curved portion and the straight portion are joined into a single molded part by sealing the gaps on the first and second sides of the intermediate strip, and the intermediate strip, molded from PP, is attached to the housing at the midpoint between the curved portion and the straight portion. as well as SEBS second covering molding portion, the second covering molding portion closes the opening length of the sheath membrane to form an inflatable sheath, the inflatable sheath having a non-square relationship between the height and width of its molded shape under low inflation pressure or when the internal and external pressures are equal.

2. The airway management device of claim 1, wherein the inflatable cuff comprises a planar cross-section that is the smallest of all other non-square cross-sections passing through the overlying molded cuff membrane, such that when the inflatable cuff is inflated, both the two lateral portions and the proximal portion expand and press against each other at the planar cross-section to cause each fused portion to become a fold and to retain the ventral opening in the first small hole, thereby limiting overinflation of the proximal portion of the inflatable cuff against the base of the user's tongue, the proximal portion of the inflatable cuff remaining aligned with and pressed against the end of the user's epiglottis.

3. The airway management device according to claim 1 or 2, wherein the device is formed by providing a removable connector on the straight portion for reducing the length from the proximal opening of the body to the trachea, thereby providing additional insertion depth of the distal end of the endotracheal tube.

4. The airway management device according to claim 1 or 2, wherein the posterior contour portion of the body is adapted to be located within the laryngopharynx, and the distal end of the body is adapted to be located within the upper esophageal sphincter, wherein an esophageal seal is formed above the distal opening of the drainage catheter immediately adjacent to the distal end, and the anterior composite curvature of the housing is the internal posterior surface of the drainage catheter, thereby reducing the volume of the distal end.

5. The airway management device of claim 4, further comprising a surrounding contour portion that covers the front composite curvature of the housing and is adapted to be positioned and pressed against the laryngopharynx, the full-length configuration of the housing from distal to proximal providing resistance against upward displacement of the distal opening due to increased esophageal pressure.

6. The airway management device of claim 4, wherein the drainage conduit and the distal opening of the drainage conduit are integral with the distal profile, and wherein the drainage conduit is not surrounded by the annular volume of the inflatable cuff.

7. The airway management device according to claim 4 further includes a closed tubular segment forming a cavity, thereby providing space for the distal portion of the inflatable cuff that shifts rearward during inflation.

8. The airway management device of claim 4, wherein, through any horizontal cross-section of the inflatable cuff, at least for the length of the distal portion of the drainage conduit, the first opposing edge and the second opposing edge remain parallel to the midplane of the curved portion, such that, after a second overmolding, the width between the first opposing edge and the second opposing edge is equal to the outer diameter of the drainage conduit.

9. The airway management device of claim 8, wherein the inflatable sheath membrane has a single continuous curvature with uniformly measured stiffness between the first opposing edge and the second opposing edge, thereby sealing posteriorly against the laryngopharynx and anteriorly against the laryngeal inlet without having an adhesive joint.

10. The airway management device according to claim 1 or 2, further comprising: A removable connector on the straight portion is used to reduce the length from the proximal opening of the body to the trachea, thereby providing additional insertion depth to the distal end of the endotracheal tube.

11. The airway management device according to claim 1 or 2, further comprising: A finger limiter forms a fixed position for the thumb during insertion to grip the proximal end when the device is removed after insertion, and serves as a depth indicator for reference teeth when the device is in place.

12. A method of forming an airway management device according to any one of claims 1 to 11, comprising: A body is provided, the body comprising an injection-molded shell of PP blended with SEBS of TPE, the shell extending from a proximal opening of the body to a distal end.

13. The method of claim 12, further comprising the step of: An intermediate strip molded from a polypropylene copolymer is attached to the outer shell between the curved and straight portions of the body.

14. The method of claim 13, further comprising the step of: A first overmolded portion of SEBS is provided, the first overmolded portion including an initial rear profile portion and a distal profile portion overmolded onto the housing, the distal periphery of the first overmolded portion defining a first opposing edge of an overmolded opening sheath membrane, the overmolded sheath membrane extending tangentially from the distal periphery in an annular curve, the endpoints of the annular curve being spaced apart from and orthogonal to the first opposing edge, the endpoints defining a second opposing edge and a straight portion overmolding a proximal end, such that the curved portion and the straight portion are combined into a single molded part through planar sealing gaps on both sides of the intermediate strip.

15. The method of claim 14, further comprising the step of: A second SEBS covering molding portion is provided to close the sheath membrane, thereby forming an inflatable sheath and completing the body.

16. The method according to any one of claims 12 to 15, wherein the inflatable bladder provides a non-square relationship between the height and width of the inflatable bladder, whereby, under low inflation pressure or when the pressure inside and outside the overmolded bladder membrane is equal, the non-square relationship combines with the overmolded bladder membrane to maintain the molded shape, produce an initial anatomical seal, and is maintained as the inflatable bladder is further inflated.

17. The method of claim 16, wherein the inflatable cuff comprises a planar cross-section that is the smallest of all other non-square cross-sections passing through the overmolded cuff membrane, such that when the inflatable cuff is inflated, both the lateral and proximal portions expand and press against each other at the planar cross-section to cause each fused portion to become a fold and to retain the ventral opening in the first small hole, thereby limiting over-inflation of the proximal portion of the inflatable cuff against the base of the user's tongue, the proximal portion of the inflatable cuff remaining aligned with and pressed against the end of the user's epiglottis.

18. The method of claim 16, wherein the device is formed by providing a removable connector on the straight portion for reducing the length from the proximal opening of the body to the trachea, thereby providing additional insertion depth of the distal end of the endotracheal tube.

19. The method of claim 16, wherein the device is formed by providing a finger limiter that forms a fixed position for resting the thumb during insertion to grip the proximal end when the device is removed after insertion, and serves as a depth indicator for reference teeth when the device is in place.

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