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"Patient Interface with an Adjustable Cushion" in Patent Application Approval Process


  2014 APR 20 (VerticalNews) -- By a News Reporter-Staff News Editor at Investment Business Weekly -- A patent application by the inventors MATULA, JR., JEROME (MONROEVILLE, PA); EATON, JASON P. (HUNKER, PA); HO, PETER CHI FAI (PITTSBURGH, PA); DiPASQUALE, JAMES (ALLISON PARK, PA); ANDREWS, DERRICK (MARKLETON, PA); SCARBERRY, EUGENE N. (TRAFFORD, PA); STEGMAN, STEVEN C. (Gibsonia, PA), filed on November 11, 2013, was made available online on April 3, 2014, according to news reporting originating from Washington, D.C., by VerticalNews correspondents.

  This patent application is assigned to Ric Investments LLC.

  The following quote was obtained by the news editors from the background information supplied by the inventors: "The present invention pertains to a patient interface for use in a non-invasive pressure support or ventilation system that supplies a flow of gas to the airway of a patient, and, in particular, to a patient interface having a seal member that is selectively adjustable relative to a faceplate or other seal supporting structure so that the user can control the position of the seal to optimize comfort and fit while also minimizing gas leak.

  "There are numerous situations where it is necessary or desirable to deliver a flow of gas non-invasively to the airway of a patient, i.e., without intubating the patient or surgically inserting a tracheal tube in the esophagus. For example, it is known to ventilate a patient using a technique known as non-invasive ventilation (NIV). It is also known to deliver a pressure support therapy to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), cheynes-stokes respiration, and congestive heart failure. Typical pressure support therapies include providing a continuous positive airway pressure (CPAP) or a variable airway pressure to the airway of the patient. Examples of variable airway pressure therapies include providing a bi-level pressure that varies with the patient's respiratory cycle, a proportional pressure that varies the delivered pressure based on the patient's respiratory effort or flow, and an auto-titrating pressure that varies the delivered pressure based on the monitored condition of the patient.

  "Non-invasive ventilation and pressure support therapies involve the placement of a patient interface, which is typically a nasal or nasal/oral mask, on the face of a patient to interface the ventilator or pressure support system with the airway of the patient so that a flow of gas can be delivered from the pressure/flow generating device to the airway of the patient. Typically patient interfaces include a mask shell having a cushion attached to the shell that contacts the surface of the patient. The mask shell and cushion are held in place by a headgear that wraps around the head of the patient. The mask and headgear form the patient interface assembly. A typical headgear includes flexible, adjustable straps that extend from the mask to attach the mask to the patient.

  "Because such masks are typically worn for an extended period of time, a variety of concerns must be taken into consideration. For example, in providing CPAP to treat OSA, the patient normally wears the patient interface all night long while he or she sleeps. One concern in such a situation is that the patient interface is as comfortable as possible, otherwise the patient may avoid wearing the interface device, defeating the purpose of the prescribed pressure support therapy. It is also important that the interface device provides a tight enough seal against a patient's face without discomfort so that gas leakage from the system at the patient-seal interface is minimized. A dilemma arises in that in order for the mask to maintain a seal without any undue gas leaks around the periphery of the mask, the mask may be compressed against the patient's face, which may decrease comfort.

  "Many patient interfaces have been develop that attempt to balance the competing interests of patient comfort versus minimizing leakage. In addressing this issue, many patient interfaces have focused on the design of the cushion. Early cushion designs were typically a flap of material or a balloon, i.e., air-filled cushion, that contacted the face of the user. Further design developments including contouring the patient contacting portion of the cushion and/or making the seal customizable to the surface or underlying tissues of the user. Still further cushions have employed multiple flaps so that the outermost flap provides a sealing function. See, e.g., U.S. Pat. No. 4,971,051 to Toffolon.

  "In addition, U.S. Pat. No. 6,530,373 ('the '373 patent') discloses a patient interface in which the position of the seal relative to the conduit is adjustable over discrete positions. This is done in the '373 patent because there is little or no control of the position of the conduit relative to the patient's face. Allowing the seal position to be adjusted allows the seal to set to a proper angle on the user depending on the position of the conduit. This patient interface, however, does not provide a stable platform on which the seal is mounted.

  "Although these conventional patient interfaces have advanced the art, the need still exists for a patient interface that improves upon existing devices, for example, to maximize patient comfort while minimizing leak, during delivery of a positive airway pressure or flow of gas to the airway of the user. In addition, existing patient interfaces also may not provide a stable platform that supports the cushion on the patient's face."

  In addition to the background information obtained for this patent application, VerticalNews journalists also obtained the inventors' summary information for this patent application: "Accordingly, it is an object of the present invention to provide a patient interface that overcomes the shortcomings of conventional patient interfaces. This object is achieved according to one embodiment of the present invention by providing a patient interface that includes a faceplate that includes a plurality of headgear attachment elements, a seal member operatively coupled to the faceplate, and an adjustment mechanism that couples the seal member to the faceplate. The seal member is adjustable relative to the faceplate from a first position to a second position and is maintained in the second position by the adjustment mechanism during use of the patient interface. The adjustment mechanism provides either a plurality of discrete positions for the seal member relative to the faceplate or a potentially infinite number of adjustment positions between these components.

  "These and other objects, features, and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. As used in the specification and in the claims, the singular form of 'a', 'an', and 'the' include plural referents unless the context clearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

  "FIG. 1 is a front perspective view of a first embodiment of a patient interface according to the principles of the present invention shown schematically connected to a pressure support system;

  "FIG. 2 is a rear perspective view of the patient interface of FIG. 1;

  "FIG. 3 is a sectional view of the adjustment mechanism in the patient interface of FIG. 1;

  "FIG. 4 is a sectional view of the seal member and faceplate coupling configuration in the patient interface of FIG. 1;

  "FIG. 5 is an exploded view of the patient interface of FIG. 1;

  "FIG. 6 is an exploded view of the adjustment mechanism in the patient interface of FIG. 1;

  "FIG. 7 is a front perspective view of a second embodiment of a patient interface according to the principles of the present invention shown schematically connected to a pressure support system;

  "FIG. 8 is a rear perspective view of the patient interface of FIG. 7;

  "FIG. 9 is a side sectional view of the patient interface of FIG. 7;

  "FIG. 10 is an exploded view of the patient interface of FIG. 7;

  "FIG. 11 is an exploded view of the adjustment mechanism in the patient interface of FIG. 7;

  "FIG. 12 is a front perspective view of a third embodiment of a patient interface according to the principles of the present invention;

  "FIG. 13 is a rear perspective view of the patient interface of FIG. 12;

  "FIG. 14 is an exploded view of the patient interface of FIG. 12;

  "FIG. 15 is a side view of a fourth embodiment of a patient interface according to the principles of the present invention;

  "FIGS. 16A and 16B are side views showing the adjustment of the seal member relative to the faceplate in the patient interface of FIG. 15;

  "FIG. 17 is a side view of the seal member in the patient interface of FIG. 15;

  "FIGS. 18-20 are side views of alternative embodiments of an adjustment mechanism that controls the position of the seal member relative to the faceplate;

  "FIG. 21 is a side view of a fifth embodiment of a patient interface according to the principles of the present invention;

  "FIG. 22 is a side view of a sixth embodiment of a patient interface according to the principles of the present invention;

  "FIG. 23 is a side view of a seventh embodiment of a patient interface according to the principles of the present invention;

  "FIGS. 24A-24C are side views illustrating the adjustment of the seal member relative to the faceplate in the patient interface of FIG. 23;

  "FIG. 25 is a side, partial sectional, view of an eighth embodiment of a patient interface according to the principles of the present invention;

  "FIG. 26 is a perspective view of alternative configurations for the seal member mount in the patient interface of FIG. 23;

  "FIG. 27 is an exploded view of a ninth embodiment of an adjustment mechanism according to the principles of the present invention;

  "FIG. 28 is a side sectional view of a patient interface including the adjustment mechanism of FIG. 27;

  "FIG. 29 is an exploded view of a tenth embodiment of an adjustment mechanism according to the principles of the present invention;

  "FIG. 30 is a front perspective view of an eleventh embodiment of a patient interface according to the principles of the present invention;

  "FIG. 31 is an exploded view of a twelfth embodiment of a patient interface according to the principles of the present invention;

  "FIG. 32 is an exploded view of a thirteenth embodiment of a patient interface according to the principles of the present invention;

  "FIG. 33 is a side view, partially in section, of a fourteenth embodiment of a patient interface according to the principles of the present invention;

  "FIG. 34 is a side sectional view of a portion of a patient interface according to a fifteenth embodiment of the present invention;

  "FIG. 35 is a side view of a sixteenth embodiment of a patient interface according to the principles of the present invention;

  "FIG. 36 is a front view of the patient interface of FIG. 35 including a detailed view of an adjustment mechanism used therein;

  "FIG. 37 is front view of a seventeenth embodiment of a patient interface according to the principles of the present invention; and

  "FIG. 38 is a side view the patient interface of FIG. 37 including a detailed view of an adjustment mechanism used therein."

  URL and more information on this patent application, see: MATULA, JR., JEROME; EATON, JASON P.; HO, PETER CHI FAI; DiPASQUALE, JAMES; ANDREWS, DERRICK; SCARBERRY, EUGENE N.; STEGMAN, STEVEN C. Patient Interface with an Adjustable Cushion. Filed November 11, 2013 and posted April 3, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=6707&p=135&f=G&l=50&d=PG01&S1=20140327.PD.&OS=PD/20140327&RS=PD/20140327

  Keywords for this news article include: Therapy, Ric Investments LLC, Investment and Finance.

  Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC

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