WO2019245593A1 - Tuyau tressé destiné à être utilisé dans des systèmes de traitement de l'apnée du sommeil qui découple des forces - Google Patents

Tuyau tressé destiné à être utilisé dans des systèmes de traitement de l'apnée du sommeil qui découple des forces Download PDF

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Publication number
WO2019245593A1
WO2019245593A1 PCT/US2018/051399 US2018051399W WO2019245593A1 WO 2019245593 A1 WO2019245593 A1 WO 2019245593A1 US 2018051399 W US2018051399 W US 2018051399W WO 2019245593 A1 WO2019245593 A1 WO 2019245593A1
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WO
WIPO (PCT)
Prior art keywords
hose
matrix
braided
longitudinal axis
braid
Prior art date
Application number
PCT/US2018/051399
Other languages
English (en)
Inventor
Richard Ewers
Andrew Dominguez
Original Assignee
Fresca Medical Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresca Medical Inc. filed Critical Fresca Medical Inc.
Priority to EP18923002.2A priority Critical patent/EP3806942A4/fr
Priority to CN201880096556.1A priority patent/CN112638459A/zh
Publication of WO2019245593A1 publication Critical patent/WO2019245593A1/fr

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Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
    • F16L11/00—Hoses, i.e. flexible pipes
    • F16L11/04—Hoses, i.e. flexible pipes made of rubber or flexible plastics
    • F16L11/08—Hoses, i.e. flexible pipes made of rubber or flexible plastics with reinforcements embedded in the wall
    • F16L11/085—Hoses, i.e. flexible pipes made of rubber or flexible plastics with reinforcements embedded in the wall comprising one or more braided layers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0875—Connecting tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08—Tubes; Storage means specially adapted therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C61/00—Shaping by liberation of internal stresses; Making preforms having internal stresses; Apparatus therefor
    • B29C61/06—Making preforms having internal stresses, e.g. plastic memory
    • B29C61/0608—Making preforms having internal stresses, e.g. plastic memory characterised by the configuration or structure of the preforms
    • B29C61/0633—Preforms comprising reinforcing elements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C61/00—Shaping by liberation of internal stresses; Making preforms having internal stresses; Apparatus therefor
    • B29C61/06—Making preforms having internal stresses, e.g. plastic memory
    • B29C61/08—Making preforms having internal stresses, e.g. plastic memory by stretching tubes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D23/00—Producing tubular articles
    • B29D23/001—Pipes; Pipe joints
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04C—BRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
    • D04C1/00—Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
    • D04C1/06—Braid or lace serving particular purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2401/00—Physical properties
    • D10B2401/04—Heat-responsive characteristics
    • D10B2401/041—Heat-responsive characteristics thermoplastic; thermosetting

Definitions

  • the present invention is related to medical systems, devices, and methods. More specifically, the invention is related to systems, devices and methods for treating obstructive sleep apnea or snoring.
  • PAP Positive Airway Pressure
  • OSA obstructive sleep apnea
  • Hoses connect at one end to the flow generator and at the other to the user via a full face, nasal or nasal pillows mask.
  • Current hose embodiments are uncomfortable, heavy, cumbersome and are susceptible to unintentional disconnection of the hose from the flow generator and/or mask. In some cases, current hose designs can even result in the user pulling the flow generator off a nearby nightstand or side table causing damage to the device.
  • Typical PAP hoses are six feet in length, which is in most cases at least double the distance between the flow generator and the user.
  • Current hoses rely on the slack in the length of the hose to mitigate forces applied to them by the user or bedding. If the hose becomes anchored or pinned along its length by the user, or on some part of the bed, the additional length can no longer be used for force mitigation. While anchored, only the remaining functional length of the hose, that length between the anchor point and the flow generator or mask, can utilize its slack to attenuate forces enacted upon it. Without the full length of the hose, the ability of slack to mitigate forces can be greatly diminished and movement from the user may cause partial to full disconnection from the flow generator and/or mask.
  • a hose that includes a braided matrix with an interior lumen.
  • the matrix includes filaments that intersect each other creating a braid.
  • a longitudinal axis runs along the lumen and the filaments intersect the longitudinal axis at a braid angle.
  • the braid angle can be varied by compressing or expanding the matrix along the direction of the longitudinal axis.
  • a polymer coating is applied to the matrix such that the matrix is substantially impermeable to air.
  • the hose has two states: (1) a relaxed state where the hose does not experience a force in the direction of the longitudinal axis; and (2) a stressed state where the hose experiences a force in the direction of the longitudinal axis.
  • the braid angle is larger in the relaxed states as compared to the stressed state.
  • the hose may have a first end and a second end, wherein the first end experiences a force in the direction of the longitudinal axis, and the hose attenuates the force as experienced by the second end.
  • the attenuation of the force from the first to the second is proportional to the distance the first has traveled away from the second.
  • the hose may also have two additional states: (1) a rotationally relaxed state where the hose does not experience a rotational force about the longitudinal axis; and (2) a rotationally stressed state where the hose experiences a rotational force about the longitudinal axis.
  • the braid angle differs between rotationally relaxed state and the rotationally stressed state.
  • the hose may further attenuate the rotational force as experienced by an end of the hose.
  • the braid angle may be at least 30 degrees larger in the relaxed state as compared to the stressed state, and the hose can be stretched to at least 130% of its length.
  • the hose may have an outer diameter ranging from 0.3 to 0.5 in,
  • the filaments have a diameter ranging from 0.005 - 0.015 in and may have a cross sectional shape selected from a group consisting of round, flat or combinations of both.
  • the filament may be comprised of a heat shapeable material selected from a group consisting of: Nylon, PET, PEN, PP, PEEK or a shape-memory metal.
  • Non heat shapeable filaments, such as conductive element filaments, may be added in conjunction with previously listed materials to the braided matrix.
  • the polymer coating may be less than 0.03 in and may be made of a silicone dispersion.
  • the braid may have a braid pattern that includes a first set of filaments that travels under a second set of filaments, and then travels over a third set of filaments, where the first set of filaments travels in a first rotation about the longitudinal axis and the second set of filaments travels in a second rotation about the longitudinal axis, wherein the first rotation is opposite to the second rotation.
  • the hose may have a bend radius 0.7 in without the hose kinking.
  • a method of manufacture for the hose is also disclosed.
  • FIG. 1 shows a schematic of a hose connected to a PAP machine (flow generator) and a sleep mask, as one possible application of the present invention.
  • FIG. 2A illustrates a 2-dimensional rendition of a single ended braiding pattern that may be used for the braided matrix of the hose.
  • FIG. 2B shows an embodiment of the braided matrix on the hose.
  • FIG. 2C illustrates a 2-dimensional rendition of a double ended braiding pattern that may be used for the braided matrix of the hose.
  • FIG. 3 demonstrates the braid angle changing in accordance with the length of the braided matrix.
  • FIG. 4 shows a cross-sectional area of a round hose, including the interior lumen of the hose.
  • FIG. 5 shows a cross-sectional area of a flat shaped hose.
  • FIG. 6 shows a hose whose cross-sectional area is a combination of round and flat shapes.
  • FIG. 7A represents the braided hose and shows the corresponding braid angle in a longitudinally relaxed state.
  • FIG. 7B represents the braided hose and shows the corresponding braid angle in a longitudinally stressed state.
  • FIG. 7C illustrates a first stressed state (top), an second more-stressed state (middle) and a third most-stressed state (bottom) for the braided hose.
  • FIG. 8A illustrates the braided hose and shows the corresponding braid angle in a rotationally relaxed state.
  • FIG. 8B illustrates the braided hose and shows the corresponding braid angle in a rotationally stressed state.
  • FIG. 9 is a not-to-scale schematic illustrating the coating of polymer on the braided matrix, from a cross-sectional view.
  • FIG. 10 illustrates the bend radius of the hose.
  • FIG. 11 presents the steps of relevance to manufacturing the braided hose of the present invention.
  • FIG. 12 illustrates an apparatus for manufacturing and heat setting the braided hose using a stationary mandrel.
  • FIG. 13 illustrates an apparatus for manufacturing and heat setting the braided hose using a mobile mandrel.
  • connection, relationship or communication between two or more entities does not necessarily mean a direct, unimpeded connection, as a variety of other entities or processes may reside or occur between any two entities. Consequently, an indicated connection does not necessarily mean a direct, unimpeded connection unless otherwise noted.
  • Hose or tube with braided matrix and interior lumen (braided hose/tube) 10
  • Second set of filaments 27 [0049] Direction of the rotation of the second set of filaments about the hose 27A
  • Step of compressing the braided matrix 115 Step of stabilizing the braid angle 125
  • the present invention provides a hose with a braided matrix and an interior lumen 10 that may be used between a PAP flow generator 05 and a sleep apnea mask 15, as in FIG. 1.
  • the hose 10 of the present invention is capable of attenuating forces in the longitudinal and rotational directions, which is not found in prior art. Hose embodiments that are not capable of attenuating forces acting upon the hose are highly susceptible to pressure changes at the mask due to kinking or detachment of the hose, which discontinue therapy to the user 16.
  • the hose 10 of the present invention is able to attenuate by stretching or compressing in response to forces applied to the hose 10 both longitudinally and rotationally, because the hose 10 is in part comprised of monofilaments 21 in a braided matrix 20, which are illustrated in FIGS. 2 A and 2B.
  • the braided matrix 20 is made using sets of filaments braided in a pattern 25.
  • One possible braiding pattern 25 that may be used is shown in FIG. 2A and is given as an example that in no part limits the spirit or scope of the present invention, which is limited only by the claims.
  • a first set of filaments 26 travels under a second set of filaments 27 and over a third set of filaments 28.
  • These sets of filaments 26, 27, 28 all travel rotationally and longitudinally about the braided hose 10, and in FIG.
  • Each set of monofilaments 21 may be comprised of one or more monofilaments 21. That is the braid pattern 25 can be single ended, comprised of a single monofilament 21, double ended, comprised of two monofilaments 21 (see FIG. 2C), or up to any manufacturable quantity of monofilaments 21.
  • One of ordinary skill in the art may substitute the braiding pattern 25 without departing from the spirit and scope of this invention.
  • the braided matrix 20 may be compressed or pulled. When there is a force in the longitudinal direction, the configuration of the braided matrix 20 would change such that the braid angle, which is defined as the angle formed between the longitudinal axis 35 of the braided hose 10 and the direction of the monofilaments 21, changes along with the length and diameter of the braided matrix 20.
  • the right side of FIG. 3 shows the braided matrix 20 in a relaxed state, with no forces acting upon it, measuring a length / 50 and with a width of W 51.
  • the left side of FIG. 3 shows the braided matrix 20 being stretched or stressed so that it now measures a length l 0 53 and width Wo 54 in a stressed state.
  • the angle formed between the longitudinal axis 35 and the direction 27A of a first set of monofilaments 27 is Q 40 in the relaxed state (right) and q 0 43 in the longitudinally stressed state (left).
  • the braid matrix 20 shown on the right has a braid angle near its maximum.
  • the braid angle When the braid angle is near its maximum, it means that the monofilaments 21 are arranged closer to perpendicular to the longitudinal axis 35 as compared to the direction of the monofilaments 21 in the stressed state (left).
  • the width of the braided matrix 20 radially expands from W Q 54 to W 51.
  • a braided hose 10 with a maximized braid angle 40 in its relaxed state can only stretch or elongate but cannot compress longitudinally.
  • a preferred embodiment can elongate to 130%-170% of the unelongated state.
  • This arrangement of the monofilaments 21 at the maximized braid angle 40 in the relaxed state decreases the interstitial space between the monofilaments 21, which in turn increases the kink resistance and crush resistance of the braided hose 10. Functionally, that translates into a braided hose 10 that does not need a large, heavy, inflexible, and thick-walled interior lumen 30.
  • the decrease in the interstitial space also increases the PIC (per-inch-count of the braid matrix 20) and decreases the braided matrix length 50 by D1, as in FIG. 3.
  • the construction of the braided hose 10 with a maximized braid angle 40 in a preferred embodiment has 17-24 PICs.
  • the maximum braid angle 40 can be achieved by either directly braiding the monofilaments 21 in a compressed state, or it can be achieved by braiding the monofilaments 21 in an elongated state and then compacting the braid matrix 20 at a later time.
  • the air supplied by the PAP machine or flow generator 05 travels to the sleep apnea mask 15 for the user 16 in the interior lumen 30 of the braided hose 10.
  • the cross- sectional area of the interior lumen 30 may be a round shape, a flat shape, or a combination of round and flat without departing from the spirit and scope of the invention. These possible cross- sectional areas are illustrated in FIGS. 4-6.
  • the force enacted upon the braided hose 10 is generated by the sleeping user changing positions e.g. turning over from one side to another.
  • a hose 10 at the end of its slack, which cannot stretch, will dislodge either the mask 15 or the flow generator 05 with any movement from the user.
  • the same hose 10 which can stretch will accommodate for the movement of the user, preventing dislodgement.
  • a preferred embodiment has an elastic response in the range between 0.7 to 1.7 lbf/in (120 to 300 n/m). If the user continues to move away from the flow generator 05, the hose 10 will continue stretch to its maximum length.
  • the braided hose 10 of the present invention is shown with a first end 31 and a second end 32, as well as a longitudinal axis 35 that runs along the lumen 30.
  • the configuration of the braided matrix 20 with a maximum braid angle 40 in the relaxed state is such that when a longitudinal force 41 is introduced at a first end 31 of the braided hose 10 as shown in FIG. 7B, the force 42 experienced at the second end 32 of the braided hose 10 is not substantially a 1 : 1 ratio but is substantially attenuated so that the force 42 experienced at the second end 32 is substantially less than the initial force 41 exerted at the first end 31 of the braided hose 10.
  • the difference between the force experienced from the first end 31 to the second end 32 is proportional to the elongation of the braided hose 10.
  • the force experienced at the second end increases proportionally until it reaches its maximum, at the braided hose’s 10 maximum length.
  • the force experienced at the first end 31 is equal to the force experienced at the second end 32.
  • This incremental increase of the experienced force as the braided hose 10 extends is shown in FIG. 7C. It should further be noted that in FIG. 7C, the longitudinal force at the second end 42 increases proportionally to the decreasing braid angle .
  • the braid angle 40 decreases, thereby increasing the internal stress of the hose and inclining it to elastically return to a relaxed state. This effect is compounded by the addition of a polymer which will elastically deform becoming inclined to return to its relaxed, unstressed, state.
  • a rotational force 46 is introduced at the first end 31 of the braided hose 10, as in FIG. 8B, the rotational force 47 at the second end 32 of the braided hose 10 is substantially less than the first rotational force 56 because of the attenuation effect of the braid matrix 20.
  • the attenuation of forces acting upon the braided hose 10 is independent of the direction of the force, longitudinally, laterally, rotationally, or any combination thereof.
  • the braided hose 10 of the present invention connects the PAP flow generator 05 to the sleep apnea mask 15, the flow generator 05 and the mask 15 are isolated from torsional forces acting upon the braided hose 10, preventing accidental disconnections, leaks, and reductions in air pressure due to kinks, which significantly improves upon prior art.
  • the braided hose 10 of the present invention has a resting state braid angle 40 substantially perpendicular to the longitudinal axis 35 of the lumen 30, when the braided hose 10 and therefore the braided matrix 20 is stretched or elongated, the braid angle decreases.
  • FIGS. 7B and 8B respectively show that the braid angle 43 of the longitudinally stressed state and the braid angle 48 of the rotationally stressed state are less than the braid angle 40 of the relaxed state where there are no external forces acting upon the braided hose 10.
  • the difference in braid angles between the relaxed state and the stressed state(s) should, in a preferred embodiment, be at least 30 degrees to ensure a good extent of flexibility in the braided hose 10.
  • the braided matrix 20 then becomes a lattice structure whose interstitial space or voids 59 are filled by the polymer 60.
  • the cross-sectional view of the polymer 60 filling the interstitial spaces 59 of the braided matrix 20 is shown in FIG. 9.
  • the material 60 used to coat the braided matrix 20 it is essential for the material to be elastomeric and with minimal thickness, preferably less than 0.03 in (0.08 mm) thick per wall, and without nodules.
  • the flexibility of the braided hose 10 is retained.
  • the difference between the outer diameter 70 of the finished braided hose 10 and its inner diameter 65 should be as small as possible without detriment to the structure of the braiding in order to retain flexibility and the desired attenuation of forces.
  • the braided hose 10 would become more stiff, rigid and inflexible, similar to a conventional polymer hose, thus losing its unique advantages.
  • the polymer 60 also needs to be substantially airtight and add to the structural effects of the hose 10 by increasing the kink and crush resistance as well as the elastic memory of the braided matrix 20.
  • the increase in kink and crush resistance is caused by the polymer 60 adding more material in the interstitial space in the braid pattern which must be displaced when acted upon by a force perpendicular to the longitudinal axis 35.
  • This perpendicular force can be a directly applied force, such as the by an appendage of the user, or indirectly by the longitudinal extension of the braided hose 10 in a coiled position.
  • the construction of the braided hose design interlaced with a polymer makes occlusion impossible from purely longitudinal forces. As the hose extends, the diameter will decrease as the braid angle becomes more longitudinal; and at a certain point the material of the monofilaments with the interstitial polymer would resist any further constriction of the braided hose 10.
  • the increase in elastic memory is caused by curing the polymer 60 to a specific orientation to which it will return when after it has been deformed.
  • polymers 60 Only specific types of polymers 60 are appropriate, as the polymer 60 must be viscous enough to enter between the interstitial spaces 59 of the braided matrix 20 and be applied thinly enough so as to not stiffen the braided hose 10 into a polymer tube.
  • a preferred polymer is a silicone dispersion because it does not support microbial growth, has a low chemical reactivity and toxicity, and is stable and inert. Additionally, silicone dispersion can be applied on the inside and outside of the interstitial voids 59 of the braided matrix 20 with a thin coating and does not delaminate from the braided matrix 20 when abraded. Also, when the silicone is utilized in the quantity and method described herein, it does not have an undesirable surface finish (e.g. sticky or tacky) for skin contact when the user 16 touches the hose 10.
  • an undesirable surface finish e.g. sticky or tacky
  • the braided hose 10 should be able to bend flexibly, with a small bend radius without kinking the hose 10 or affecting the pressure of air in the interior lumen 30.
  • the braided hose 10 can support a bend radius of 0.7 in without kinks that affect the flow or pressure inside the interior lumen 30, shown in FIG. 10.
  • FIG. 11 illustrates the major steps needed to manufacture the braided hose 10 that is disclosed by the present invention.
  • the method 100 of manufacturing the braided hose 10 as taught by the present invention consists of steps 105-135.
  • a braided matrix 20 with an interior lumen 30 should be provided in step 105; materials for the filaments used to form the braided matrix may be selected from nylon, PET, PEN, PP, and/or PEEK.
  • the braided matrix 20 should be compressed in step 115 such that the braided matrix 20 has a maximum braid angle 40.
  • the braided matrix 20 is preferably compressed at least 50% lengthwise compared to a non-compressed or relaxed state, and the braid angle 40 of the compressed matrix is preferably increased by at least 30 degrees in step 115.
  • the braid angle 40 should be stabilized in step 125, which may be achieved through heat setting the braid.
  • the braided matrix 20 elastically returns to the relaxed state with a maximum braid angle 40 after being deformed by elongation or torsion.
  • This stabilization step essentially flips the matrix’s relaxed and stressed states - prior to stabilization, the matrix’s relaxed state has a braid angle that is less than the stressed state, while after stabilization the converse is true.
  • a polymer 60 may be applied to the braided matrix 20 in step 135, in the interstitial spaces 59, interior, and exterior of the braided matrix 20, preferably with a polymer coating thickness of less than 0.03 in.
  • a preferred polymer 60 is a silicone dispersion.
  • the braided matrix 20 should preferably be capable of stretching 130% of the post- stabilization length after the polymer 60 has been applied (step 135).
  • the polymer 60 may be applied to the interior surface of the braided matrix 20, the outer surface of the braided matrix 20 or some combination thereof; however, it is preferred that the braided matrix 20 be coated with the polymer 60 on both the inner and outer surface, so that the inner lumen of the braided hose 10 is substantially smooth bore in order to minimize airflow resistance. More specific information related to manufacturing the braided hose 10 follows.
  • Heat setting ensures that the braid angle 40 along the length of the braided hose 10 stays near its maximum when no forces are exerted upon the braided hose 10. Heat setting guarantees that when deformation (i.e. stretching and/or twisting) occurs, the braided hose 10 will elastically return to its relaxed state, where the braided angle 40 is maximized. Additionally, heat setting the braided matrix 20 allows it to become further processed more easily. Heat setting requires the use of a monofilament 21 that will plastically deform with the application of heat, such as a thermoplastic or memory metal.
  • the inner core may be slightly smaller, by approximately 0.005 - 0.015 in (0.127 - 0.381 mm), compared to the maximum size of the braid, in order to ensure that the braid matrix 20 stays near its maximum braid angle 40.
  • the fit between the inner core and the braided hose 10 should be loose enough that the braided hose 10 can be ejected off of the internal core after heat setting.
  • the inner core can be made from individual mandrels or a stationary core.
  • FIG. 12 illustrates an apparatus for manufacturing and heat setting the braided matrix.
  • a spool track with monofilament carriers 215 rotates within a spool plane 220 and releases monofilaments 21 that converge and interweave at the convergence zone 225 about a stationary mandrel 210. This interweaving creates a braided matrix 200.
  • a ring heater 205 Near to the convergence zone 225, a ring heater 205 must be placed to heat the braided matrix 200 to the setting temperature while it is simultaneously being pulled off the stationary mandrel 210.
  • the previously specified component locations are requisite as to have a core on which to set the braided matrix 200 to the correct diameter, but not long enough that the braided matrix 200 will become stuck and neck down so that it cannot be removed with a tensile load.
  • the braided tube, set to the correct diameter can then be wrapped around a spool for shipment, storage or usage and the requisite length can then be cut at a later time.
  • An alternative method for manufacturing utilizes a mobile mandrel instead of a stationary one onto which the matrix is braided. This is shown in FIG. 13.
  • a mobile mandrel 212 is loaded behind the convergence zone 225 into the braided matrix 200.
  • the mobile mandrel 212 will move in the direction 213 of braiding until the mandrel 212 is fully enveloped by the braided matrix 200.
  • the braid covered mandrel can then be heated through a single or series of heater rings (as in FIG. 12) through which it can pass.
  • the braided matrix 200 can alternatively be cut after the end of the mobile mandrel 212 creating a mobile braid covered mandrel which can be removed.
  • the braid covered mandrel can be heated alone, or in a batch, in an oven as to set the braid to the diameter of the mandrel. At which point, the mobile mandrel 212 is delaminated to remove the braided matrix from the mandrel.
  • an inner core with a high thermal conductivity such as stainless steel
  • the application of heat must be below the melting point and preferably above the glass transition temperature, so as to allow the material to deform plastically but not degrade.
  • the preferred heat setting temperature with PET material is 220°C (428°F), which is between the melting point of 250°C (482°F) and the glass transition temperature of 67°C (l53°F). As the heating temperature increases, the time it takes to set the braid inversely decreases. The preferred time to heat set is between 0.5 min and 1.5 min.
  • the braided hose 10 is preferably heat set to a length at least as long as the length of the desired finished tube, e.g. preferably 6 ft (183 cm) to create a continuous length of braided hose 10.
  • Longer braided hoses may be heat set in increments of the preferred length of the braided hose 10.
  • the heat setting of the braid can be done at the time of braiding of the monofilaments 21 onto a mandrel, as an in-line process, or separately, when the braided matrix 20 is loaded onto a mandrel after braiding.
  • the performance characteristics of the braided hose 10 greatly depend upon the following factors: a) the braid pattern 25, b) the diameters of the braided tube 10 and the size of the monofilaments 21, and c) the material of the braided matrix 20.
  • the braided pattern 25 affects the kink resistance, crush resistance, expansion/compression ratio and stiffness of the braided matrix 20.
  • the braid pattern 25 is preferably run double ended, at a full-load, where a first pair of monofilaments 26 travels under a second pair of monofilaments 27 and then travels over a third pair of monofilaments 28 while the first and second pairs of monofilaments 26 and 27 are rotating in opposite directions 26A and 27A.
  • This braid pattern 25 utilizes a 100% carrier capacity of the braiding machine, meaning that this braid pattern has the most proficient linear throughput.
  • a large diameter braided tube 10 with small monofilaments 21 will have a very different performance than a small diameter braided tube 50 with large monofilaments 21.
  • a preferred embodiment can be constructed with a wall thickness to cross-sectional area ratio of less than 0.5 in/in 2 and preferably greater than 0.2in/in 2 .
  • a preferred embodiment has an outer diameter 70 ranging from 0.30 to 0.50 in (7.5 - 12.5mm) with a monofilament 21 diameter of 0.005 - 0.015 in (0.127 - 0.381 mm). Both round and flat fibers of different sizes can be used, but a round fiber is preferred due to its uniform characteristics when manipulated in different orientations.
  • the material of the braid matrix 20 additionally affects the performance of the finished braided hose 10.
  • PET polyethylene terephthalate
  • the FRESCA hose Provided below are the properties of a preferred embodiment of the braid matrix 20 and finished braided hose 10, hereinafter “the FRESCA hose”.
  • the superior performance of the FRESCA hose is its performance is due in part to the ratio of wall thickness to cross-sectional area. While the specifications of a hose are affected by material, design, size, and structure, the wall thickness to cross-sectional area is a good performance indicator of the hose. Having a lower wall thickness to cross-sectional area ratio allows for a more lightweight and flexible hose while maintaining a large cross-sectional area for high flow rates.
  • the FRESCA hose is able to achieve a low wall thickness to cross-sectional area ratio of only 0.26.
  • the braided matrix may also include shielded or insulated metal wires, open lumens, or heatable elements woven into the braided matrix. This is shown in FIG. 13, with shielded or insulated metal wires, open lumens, or heatable elements 230 being woven together with the monofilaments 21. These wires or lumens can be in addition to the monofilaments in the braid pattern, or in substitution for one or more of the monofilaments.
  • the utility of these wires or lumens is to connect an electrical or pneumatic sensor or other device located in the headgear, mask or on the hose, to the flow generator.
  • the heatable elements may be used to heat the length of the hose to prevent condensation, also known as rain out, from occurring within the hose or mask or as a comfort feature.
  • the FRESCA hose 10 has a low weight/length ratio, which is less cumbersome and more convenient for the user 16, due to the aforementioned properties (see Table 2).
  • the small bend radius 75 and high droop percentage indicate a high flexibility of the braided hose 10, which allows for an increased range of motion for the user 16.
  • the hose 10 has the ability to readily stretch with tensile loads. This is a useful feature for decoupling tensile loads due to force on the hose 10.
  • the pressure of air flow within the hose is unaffected even at +10% or +20% stretched lengths. Maintaining pressure while stretching the hose 10 means fewer impediments with PAP therapy in situations where the user 16 stretches the hose 10.
  • the FRESCA system uses an expiratory valve that governs exhalation resistance. Therefore, it is not as susceptible to changes in air flow. If enough flow is being delivered to counteract any non-intended leak from the mask, the FRESCA system will become pressurized. Because of this, the FRESCA system can tolerate a hose 10 that stretches and consequentially reducing the airflow delivered to the user as seen in Table 3 and Table 4.
  • Table 3 shows the reduction in airflow from elongating the hose an additional 10 & 20% at pressures of 4, 12, & 20 cm FLO.
  • Table 4 shows the negligible effect from the reduction of flow caused by the elongation of the hose at pressures of 4, 12 & 20 cm H 2 0.
  • braided hoses are common, previously disclosed and available hoses are used for a very different purpose and are constructed in a significantly different manner such that they are not well-suited for use in sleep apnea systems.
  • Braided hoses are mainly used in high pressure applications, greater than 7000 cm H 2 0 (lOOpsi), where the braid can be used to reinforce an underlying airtight polymer hose.
  • the unique braided hose structure and method of construction described herein may be applicable to other applications outside the scope of PAP therapy.
  • Other medical respiratory, pneumatic, or general fluid line applications may find the unique characteristics of this hose appropriate to their intended use.
  • PAP therapy is working within pressures in the 2 - 30 cm H 2 0 (0.03 - 0.43 psi) range, several orders of magnitude less than typical reinforced braided hoses.
  • Reinforced braided hoses have braid covering the outer surface of a polymer tube or layered between two different polymer tubes, co-extruded in the wall of the polymer or otherwise constructed. This construction utilizes the polymer hose as an airtight conduit for the delivery of a pressurized medium and the braid to act solely as reinforcement to the underlying hose. The reinforcement from the braid only works in this construction as a protection from over expansion due to internal hoop stresses.
  • Typical reinforced braided tubes require a large polymer wall thickness to provide adequate kink and crush resistance, reducing flexibility and suitability for use in PAP system applications.
  • FIG. 1 Another example from the prior art is a high-pressure hose with an external braid cladding over an internal tube.
  • the sample used for comparison had an inner diameter of 0.20” and an outer diameter of 0.30”. Its wall thickness to cross sectional area ratio is 1.59— compared to the FRESCA hose’s ratio of 0.26, this is nearly a 6-fold difference.
  • Table 6 lists the performance characteristics of the externally braided hose. Again, the externally braided hose is relatively heavy, not particularly flexible, has poor stretch, and not intended to provide a supple feel. The poor characteristics of other types of braided hoses contrast sharply with the novel properties of the FRESCA hose.
  • the superior performance of the FRESCA hose has multiple benefits for a PAP user.
  • a typical PAP user attempts to sleep while wearing a mask for PAP treatment. Due to the sleep apnea condition, PAP patients intrinsically have issues with obtaining proper sleep. Any additional external distractions further prevent the user from obtaining proper sleep. To that end, user perception, user interaction, and user comfort are just as important as the functional performance of the FRESCA hose.
  • the FRESCA hose mitigates distractions in size, weight, flexibility, and tug as compared to a conventional PAP hose.
  • the small size of the FRESCA hose is much less of a distraction for the user.
  • the FRESCA hose diameter is approximately a third of the diameter of a typical PAP hose, reducing its visual and physical presence.
  • a conventional PAP hose is typically uncomfortable to sleep on due to its large size. If a user lies on the FRESCA hose, however, they may not even notice that it is there, due to the relatively small size of the FRESCA hose.
  • a user with a FRESCA hose would not need as much space compared to using a conventional PAP hose.
  • the weight of the hose can affect comfort during sleeping.
  • the FRESCA hose including a 6 ft hose, the flow generator connector, and the mask connector, weighs only 1.3 oz, whereas a conventional 6ft PAP hose has a weight of 4.3 oz, nearly three times heavier.
  • a lighter hose creates inherently less pull on the mask and the flow generator.
  • the FRESCA hose is less cumbersome compared to a conventional PAP hose and is more convenient for the user.
  • the flexibility of the hose affects its range of motion.
  • the FRESCA hose has a bend radius of 0.7” compared with a conventional hose that has a bend radius of ⁇ l”.
  • the greater flexibility allows for an increased range of motion for the user. For example, users that move in their sleep can find it distracting when a typical PAP hose does not conform to the user’s motion.
  • the FRESCA hose has greater flexibility, which allows for more movement of the hose, conforming better to the user’s movement.
  • the FRESCA hose can elongate by 50% percent at a small loading of 1.1 lbs. while still providing 90% of its pressure.
  • a conventional PAP hose will minimally stretch. Having a high elongation is useful in that the hose decouples tensile loads from the mask and flow generator.
  • conventional PAP hoses provide nearly a 1 : 1 force transmission from the hose to flow generator or mask due to their poor elongation. This makes conventional PAP hoses prone to dislodging the mask or applying a distracting tug or drag to a user intent on sleeping.
  • the FRESCA hose will stretch, mitigating a distracting tug or drag on the user.

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Emergency Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Textile Engineering (AREA)
  • Rigid Pipes And Flexible Pipes (AREA)

Abstract

L'invention concerne un tuyau qui comprend une matrice tressée avec une lumière intérieure. La matrice comprend également des filaments qui se croisent, créant une tresse, un axe longitudinal qui s'étend le long de la lumière et les filaments croisant l'axe longitudinal selon un angle de tressage. L'angle de tressage peut être modifié par compression ou expansion de la matrice le long de la direction de l'axe longitudinal. Un revêtement polymère est appliqué sur la matrice de telle sorte que la matrice est sensiblement imperméable à l'air. Le tuyau présente deux états : (1) un état relâché dans lequel le tuyau ne subit pas de force dans la direction de l'axe longitudinal ; et (2) un état contraint dans lequel le tuyau subit une force dans la direction de l'axe longitudinal. L'angle de tressage est plus grand dans l'état relâché par comparaison à l'état contraint. L'invention concerne également une méthode de fabrication du tuyau.
PCT/US2018/051399 2018-06-18 2018-09-17 Tuyau tressé destiné à être utilisé dans des systèmes de traitement de l'apnée du sommeil qui découple des forces WO2019245593A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP18923002.2A EP3806942A4 (fr) 2018-06-18 2018-09-17 Tuyau tressé destiné à être utilisé dans des systèmes de traitement de l'apnée du sommeil qui découple des forces
CN201880096556.1A CN112638459A (zh) 2018-06-18 2018-09-17 用于解耦力的睡眠呼吸暂停治疗系统的编织软管

Applications Claiming Priority (6)

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US201862686442P 2018-06-18 2018-06-18
US62/686,442 2018-06-18
US201862694126P 2018-07-05 2018-07-05
US62/694,126 2018-07-05
US201862722580P 2018-08-24 2018-08-24
US62/722,580 2018-08-24

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US4332278A (en) * 1976-04-14 1982-06-01 Titeflex Corporation Braided-wire sheathing having bundled strands twisted to equalize tension
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US20140246025A1 (en) * 2012-04-13 2014-09-04 Fresca Medical, Inc. Auto-feedback valve for a sleep apnea device
US20170137978A1 (en) * 2015-11-13 2017-05-18 Federal-Mogul Powertrain, Llc Braided textile sleeve with axially collapsible, anti-kinking feature and method of construction thereof
US20170226671A1 (en) * 2016-02-09 2017-08-10 Federal-Mogul Powertrain, Llc Braided textile sleeve with self-sustaining expanded and contracted states and enhanced "as supplied" bulk configuration and methods of construction and supplying bulk lengths thereof

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EP3806942A1 (fr) 2021-04-21
EP3806942A4 (fr) 2022-07-06

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