Source: https://patents.google.com/patent/US20110088698A1/en
Timestamp: 2019-05-21 09:29:04
Document Index: 586587094

Matched Legal Cases: ['§120', '§120', '§120', '§119', 'Application No. 60', '§120', '§120']

US20110088698A1 - Patient contacting seal and mask using same - Google Patents
Patient contacting seal and mask using same Download PDF
US20110088698A1
US20110088698A1 US12/966,116 US96611610A US2011088698A1 US 20110088698 A1 US20110088698 A1 US 20110088698A1 US 96611610 A US96611610 A US 96611610A US 2011088698 A1 US2011088698 A1 US 2011088698A1
US12/966,116
US8485190B2 (en
Shari S. Barnett
Patrick M. Handke
Kristine K. Sabo
Ronald E. White
Benedict R. McElroy
Virgina A. Handke
1995-09-08 Priority to US08/525,404 priority Critical patent/US5647357A/en
1997-04-03 Priority to US08/832,267 priority patent/US5884624A/en
1998-10-05 Priority to US10309198P priority
1999-09-01 Priority to US09/388,326 priority patent/US6397847B1/en
2002-03-26 Priority to US10/106,658 priority patent/US6895965B2/en
2005-02-04 Priority to US11/051,854 priority patent/US7870859B2/en
2010-12-13 Priority to US12/966,116 priority patent/US8485190B2/en
2010-12-13 Application filed by RIC Investments LLC filed Critical RIC Investments LLC
2011-04-21 Publication of US20110088698A1 publication Critical patent/US20110088698A1/en
2013-07-16 Publication of US8485190B2 publication Critical patent/US8485190B2/en
2015-10-22 Adjusted expiration legal-status Critical
A seal and a respiraoty mask having a seal adapted for confronting engagement with a surface of a user to form an interface therewith. The seal includes a first portion defined by a gel substance. In one embodiment, the seal includes a selectively formable substance adapted to be molded from a first pattern into a second pattern and to retain the second pattern responsive to being so molded. The seal and mask having the seal in this embodiment is tailored to patient by causing the formable portion of the seal to be placed in a malleable state, applying the seal to the patient while the formable portion is in the malleable state, and causing the formable portion to be placed in a fixed state to retain a shape generally conforming to the portion of the patient underlying the seal.
This application is a Continuation application under 35 U.S.C. §120 of U.S. patent application Ser. No. 11/051,854, filed Feb. 4, 2005, which is a Continuation application under 35 U.S.C. §120 of U.S. patent application Ser. No. 10/106,658, filed Mar. 26, 2002, now U.S. Pat. No. 6,895,965, which is a Divisional application under 35 U.S.C. §120/121 of U.S. patent application Ser. No. 09/388,326, filed Sep. 1, 1999, now U.S. Pat. No. 6,397,847, which claims priority under 35 U.S.C. §119(e) from Provisional U.S. Patent Application No. 60/103,091 filed Oct. 5, 1998, and which is also a Continuation-in-Part under 35 U.S.C. §120 of U.S. patent application Ser. No. 08/832,267 filed Apr. 3, 1997, now U.S. Pat. No. 5,884,624, which is a Continuation under 35 U.S.C. §120 of U.S. patent application Ser. No. 08/525,404 filed Sep. 9, 1995, now U.S. Pat. No. 5,647,357.
U.S. Pat. No. 5,181,506 describes a protective gas mask for military applications. The mask includes a three-layer face piece, the central layer of which is a thick layer of relatively stiff material having preformed V-shaped channels. The channels are “overfilled” with a gel or both gel and compressed air to create bulges in an inner face-contacting layer that are adapted to seal against the contours of a user's face. The inherent stiffness of the central layer in combination with the structural rigidity provided by the V-shaped channels, especially when overfilled with gel/air, results in a comparatively unyielding facial seal. Indeed, the mask is deployed in combination with a tightly fitting hood in order to draw the face piece firmly against the user's head to generate the desired facial seal. As will be appreciated, the comfort afforded such a construction is quite limited and certainly not appropriate for those applications, such as respiratory therapy situations, where a user must occasionally wear a mask for prolonged periods of time.
Accordingly, it is an object of the present invention to provide a customizable seal adapted for confronting engagement with a surface of a user to form a sealed interface therewith that overcomes the shortcomings of conventional seal techniques. This object is achieved, according to one embodiment of the present invention, by providing a seal having a first portion defined by a pliable gel substance that recoils back to substantially its original shape when not stressed and that has a resiliency defined as a Shore 00 durometer of less than about 10. The seal includes a first portion adapted to contact a face of a human user. In a further embodiment, the seal is also formed from a selectively formable substance that is adapted to be molded from a first pattern into a second pattern and to retain the second pattern responsive to being so molded. The first portion of the seal has the effect of providing a micro-customization of the seal in that the seal readily conforms to match the external contours of the user, such as those features defined in a patient's soft tissues. The second portion of the seal has the effect of providing a macro-customization in that it can be molded to match the general features, such as the underlying bone structure, of the patient.
FIG. 1 is a front elevation view of a respiratory mask including a first embodiment of a seal according to the present invention;
FIG. 3 is a cross-sectional view of the respiratory mask taken along line III-III of FIG. 1;
FIG. 4 is a cross-sectional view of the respiratory mask taken along line IV-IV of FIG. 2;
Referring to FIGS. 1-4, there is generally indicated at 10, a respiratory mask including a shell or body 12 having an open side 14 that defines a generally annular surface 16 to which is sealingly affixed a seal 18 constructed according to a first embodiment of the instant invention. Mask body 12 is preferably, although not necessarily, a generally rigid shell, whereas facial seal 18, in the illustrated embodiment, is a flexible, resilient unitary member that will be described in greater detail hereinafter.
In accordance with the embodiment of the present invention illustrated in
FIGS. 3 and 4, the entirety of annular member 27 is formed from a gel substance, such as a viscoelastic polyurethane polymer, possessing resilience or recoil characteristics corresponding substantially to those of human fat tissue. More specifically, seal 18 preferably has a resiliency as defined by durometer measured on the Shore 00 scale, which is used to gauge the resiliency of very soft resilient materials, of about 10 or softer and, most preferably, about 0. Such resiliency corresponds substantially to that of human fat tissue, which also exhibits a durometer reading of 0 on a Shore 00 scale. With respect to the embodiment of seal 18 illustrated in FIGS. 1-4, the durometer of seal 18 corresponds to the resultant durometers of annular member 27 and the later described protective covering (whose durometer is essentially negligible because of the thinness and pliability of the covering). As for the seal illustrated in FIG. 5, wherein the annular member 27 has no protective covering, the durometer of the facial seal is that of the annular member.
Although inherently capable of filling spatial voids, human fat tissue has negligible structural integrity and may not be self-sustaining Consequently, any seal possessing structural characteristics essentially identical to fat would be impractical from a usage standpoint. That is, if a seal were fabricated from a material structurally indistinguishable from human fat tissue in terms of resiliency, it may tend to sag into an amorphous shape under the influence of gravity and, thus, would not effectively conform to the contours of a user's face even if the headstrap tension was quite high. It will be appreciated, therefore, that a properly designed seal must substantially, but not identically, mimic human fat tissue from a structural, particularly resiliency, perspective. Stated differently, the seal must exhibit some measurable recoil “memory” whereby it is structurally self-sustaining, capable of gently conforming to the topography of a user's face under the influence of low headstrap tensile forces, resistant to distorting gravitational effects and self-restorable to its original configuration when removed from contact with the user's face. It must also be resistant to distortion due to positive gas pressure supplied to the mask.
As presently contemplated, the wall thickness of peripheral wall portion 28 of annular seal member 27 of seals 18 and 118, excluding bosses 42, preferably ranges from about 0.2 to 0.3 inches. The weight of the seals 18 and 118, depending on the size of mask bodies 12 with which they are used, ranges from about 1 to 2 ounces, a weight that has been discovered to be virtually unnoticeable to patients who have worn masks constructed according to the present invention in clinical tests. Furthermore, the fat-like resiliency qualities of the gel substance that forms annular member 27 creates in the wearer a comparatively cool and natural tactile sensation when the facial seal is in contact with the user's face. Also, much like human fat tissue performs, seals 18 and 118 effectively fill gaps and mold to the user's facial topography thereby minimizing leakage of gas supplied to the mask. Thus, seals 18 and 118 provide the beneficial aspects of micro-customization as discussed above.
Indeed, experimental testing has shown that respiratory masks fitted with facial seals in accordance with the present invention exhibit minimal gas leaks with headstrap tensile forces of 3 pounds or less, a value substantially less than related masks presently known in the art. The facial seals described herein thus enable respiratory masks to be worn by users for prolonged periods with little or no measurable discomfort. This phenomenon is especially important to users who must wear respiratory masks for extended periods, such as patients undergoing respiratory therapy. Such individuals find that because of the comfort afforded by the facial seals 18, 118, their compliance with the respiratory treatment increases and the therapeutic benefits of the treatment are more fully realized.
Referring again to FIG. 6, as with the embodiment illustrated in FIGS. 1-5, an attaching mechanism 36, which, in a preferred embodiment of the present invention includes an anchorage device 38, attaches the seal, such as seal 218, 220 or 222, to an external member. In the illustrated embodiment, the external member is mask body 12. It is to be understood, however, that the seals of the present invention, i.e., seals 18, 118, 218, 220 and 222, need not be relatively permanently affixed to the external member, such as the mask body. Quite the contrary, the seals of the present invention can be associated with the external member without any significant, i.e., relatively permanent, attachment between the seal and the external member. For example, FIG. 9 illustrates an embodiment of the present invention in which seal 318 is an annular member that is applied to an exposed surface 80 of a mask 82, which is any conventional respiratory mask, and includes a mask body 84 and a cushion 86. Seal 318 has the characteristics of any of the seals discussed above.
FIGS. 10 and 11 illustrate a further embodiment of a step for use in the method by which the seal of the present invention is customized to match the general features of the user. In this embodiment, a retaining member 80 is provided proximate to seal 218 to prevent movement of the seal during the process in which the second portion 52 changes shape from the first pattern to the second pattern. Although seal 218 is illustrated in FIGS. 10 and 11, it is to be understood that the use of a retaining member during this stage of the interfacing process is not limited to this seal. On the contrary, retaining member 80 can be used in conjunction with any seal having a portion that is molded from a first pattern to a second pattern, such as seal 220 or 222, to assist in retaining the shape of the seal as it is being applied to the patient to customize to the physical features of that patient. The present invention also contemplates using a retaining member in a finished seal of any of the type discussed above to augment the support of the seal in use, i.e., to increase the stiffness of the seal.
In the embodiment illustrated in FIGS. 10 and 11, retaining member 80 is provided proximate to seal 218 either before seal 218 is heated or after second portion 52 of seal 218 has been heated to a level sufficient to cause the second portion to transition from the fixed state to the malleable state. Retaining member 80, being disposed proximate to the outer surface 70 periphery of seal 218, minimizes outward expansion of seal 218 so that the act of compressing the seal on the user does not tend to flatten the seal, but enhances the ability of second portion 52 to mold to the general shape of the patient.
It is to be understood that the retaining member can be provided at a variety of locations, or a plurality of locations, depending on how the user wants to support the seal, either during the customization process or while the seal is in use. For example, the retaining member may be provided proximate to the inner surface 68 and/or outer surface 70. As illustrated by hidden line 82 in FIG. 10, which illustrates the distal surface of retaining member 70, the retaining member can have a variety of shapes depending on the pattern of support to be provided. It is to be further understood that retaining member 80 need not be an annular member, but may be a portion thereof and attachable to mask body 12, for example, to provide the desired support function.
It should be further understood that the above described alternative embodiments of the present invention are not intended to be an exhaustive list of all of the possible uses for the seal of the present invention. In general, the seal of the present invention can be used in any situation where there is an interface between a user and an external device. It should be noted that the term “seal” is intended to encompass any interface between a patient and an external device. The term “seal” should not be construed narrowly, for example, to cover only those situations where the seal prevents foreign matter, such as water or gas, from passing to the user, e.g., a water-tight seal or an air-tight seal. It is not necessary in all embodiments of the present invention that the seal prevent matter from passing to the user. For example, if the seal of the present invention is used as an earpiece for a telephone receiver, it is not necessary that the interface between the receiver and the user provided by the seal be airtight or watertight. All that is required is that the seal of the present invention provide a cushioned and customizable interface between the user and the external device, such as the telephone receiver.
1. A facial seal adapted to be coupled to a mask shell, the facial seal comprising:
a mask shell attaching portion adapted to be coupled to a mask shell;
a patient portion adapted to contact a face of a human user or be disposed proximate to a face of a user responsive to the facial seal being donned by such a user, and wherein the patient portion is distal from the mask shell attaching portion; and
a wall portion extending between the mask shell attaching portion and the patient portion structurally supporting the patient portion relative to the mask shell attaching portion and defining a cavity adapted to receive at least a portion of such a user's nose, wherein the mask shell attaching portion, the patient portion, and the wall portion are all part of a single, unitary solid structure formed from a pliable viscoelastic material such that the unitary solid structure exhibits viscoelasticity and recoils back to substantially its original shape when not stressed, and wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion has a resiliency defined as a Shore 00 durometer of less than about 10.
2. The facial seal of claim 1, wherein the patient portion is provided at a first end of the wall portion and the mask shell attaching portion is provided at a second end portion of the wall portion, wherein the mask shell attaching portion is adapted to attach to a body of a respiratory mask, and wherein the patient portion is contoured.
3. The facial seal of claim 2, further comprising an attaching means for attaching the mask shell attaching portion to the body of the respiratory mask.
4. The facial seal of claim 3, wherein the attaching means comprise a member less resilient than the seal.
5. The facial seal of claim 1, further comprising means for strengthening the wall portion of the seal.
6. The facial seal of claim 1, wherein the seal has a generally triangular shape.
7. The facial seal of claim 1, wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion has a Shore 000 durometer of from about 20 to about 45.
8. The facial seal of claim 1, wherein the viscoelastic material is a gel substance comprising a viscoelastic polyurethane polymer.
9. The facial seal of claim 1, further comprising a protective covering disposed over at least a portion of the seal.
10. The facial seal of claim 1, wherein the seal is also formed from a selectively formable substance that is adapted to be molded by a compressive force acting on the patient portion from a first pattern into a second pattern and to retain the second pattern responsive to being so molded and even after the compressive force is removed.
11. A respiratory mask comprising:
(a) a respiratory mask body;
(b) a seal comprising:
(1) a mask shell attaching portion adapted to be coupled to the mask body;
(2) a patient portion adapted to contact a face of a human user or be disposed proximate to a face of a user responsive to the facial seal being donned by such a user, and wherein the patient portion is distal from the mask shell attaching portion; and
(3) a wall portion extending between the mask shell attaching portion and the patient portion structurally supporting the patient portion relative to the mask shell attaching portion and defining a cavity adapted to receive at least a portion of such a user's nose, wherein the mask shell attaching portion, the patient portion, and the wall portion define a unitary structure and are all part of a single, unitary solid structure formed from a pliable viscoelastic material such that the unitary solid structure exhibits viscoelasticity and recoils back to substantially its original shape when not stressed, and wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion has a resiliency defined as a Shore 00 durometer of less than about 10; and
(c) an attaching member coupled to the mask shell attaching portion of the seal and to the respiratory mask body to attach the seal to the respiratory mask body.
12. The mask of claim 11, wherein the attaching member is less resilient than the seal.
13. The mask of claim 11, further comprising means for strengthening the wall portion of the seal.
14. The mask of claim 11, wherein the seal has a generally triangular shape.
15. The mask of claim 11, wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion has a Shore 000 durometer of from about 20 to about 45.
16. The mask of claim 11, wherein the viscoelastic material is a gel substance comprising a viscoelastic polyurethane polymer.
17. The mask of claim 11, further comprising a protective covering disposed over at least a portion of the seal.
18. The mask of claim 11, wherein the seal is also formed from a selectively formable substance that is adapted to be molded by a compressive force acting on the patient portion from a first pattern into a second pattern and to retain the second pattern responsive to being so molded and even after the compressive force is removed.
19. A facial seal adapted to be coupled to a mask shell, the facial seal comprising:
a mask shell attaching portion adapted to be coupled to a mask shell, the mask shell attaching portion having a first exterior surface structured to be exposed to the ambient environment surrounding the facial seal;
a patient portion adapted to contact a face of a human user or be disposed proximate to a face of a user responsive to the facial seal being donned by such a user, and wherein the patient portion is distal from the mask shell attaching portion, the patient portion having a second exterior surface structured to be exposed to the ambient environment surrounding the facial seal; and
a wall portion extending between the mask shell attaching portion and the patient portion structurally supporting the patient portion relative to the mask shell attaching portion and defining a cavity adapted to receive at least a portion of such a user's nose, the wall portion having a third exterior surface structured to be exposed to the ambient environment surrounding the facial seal, wherein the mask shell attaching portion, the patient portion, and the wall portion, including the first exterior surface, the second exterior surface and the third exterior surface, are all part of a single, unitary solid structure formed from a pliable material such that the unitary solid structure recoils back to substantially its original shape when not stressed and wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion, including the first exterior surface, the second exterior surface and the third exterior surface, has a resiliency defined as a Shore 00 durometer of less than about 10.
20. The facial seal of claim 19, wherein the patient portion is provided at a first end of the wall portion and the mask shell attaching portion is provided at a second end portion of the wall portion, wherein the mask shell attaching portion is adapted to attach to a body of a respiratory mask, and wherein the patient portion is contoured.
21. The facial seal of claim 20, further comprising an attachment mechanism integrally molded into mask shell attaching portion for attaching the mask shell attaching portion to the body of the respiratory mask, wherein the attachment mechanism is less resilient than the mask shell attaching portion.
22. The facial seal of claim 19, further comprising means for strengthening the wall portion of the seal.
23. The facial seal of claim 19, wherein the seal has a generally triangular shape.
24. The facial seal of claim 19, wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion, including the first exterior surface, the second exterior surface and the third exterior surface, has a resiliency defined as a Shore 000 durometer of from about 20 to about 45.
25. The facial seal of claim 19, wherein the pliable material is a viscoelastic material such that the unitary solid structure exhibits viscoelasticity.
26. The facial seal of claim 25, wherein the viscoelastic material is a gel substance comprising a viscoelastic polyurethane polymer.
27. A respiratory mask comprising:
(1) a mask shell attaching portion adapted to be coupled to the mask body, the mask shell attaching portion having a first exterior surface structured to be exposed to the ambient environment surrounding the facial seal;
(2) a patient portion adapted to contact a face of a human user or be disposed proximate to a face of a user responsive to the facial seal being donned by such a user, and wherein the patient portion is distal from the mask shell attaching portion, the patient portion having a second exterior surface structured to be exposed to the ambient environment surrounding the facial seal; and
(3) a wall portion extending between the mask shell attaching portion and the patient portion structurally supporting the patient portion relative to the mask shell attaching portion and defining a cavity adapted to receive at least a portion of such a user's nose, the wall portion having a third exterior surface structured to be exposed to the ambient environment surrounding the facial seal, wherein the mask shell attaching portion, the patient portion, and the wall portion, including the first exterior surface, the second exterior surface and the third exterior surface, are all part of a single, unitary solid structure formed from a pliable material such that the unitary solid structure recoils back to substantially its original shape when not stressed, and wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion, including the first exterior surface, the second exterior surface and the third exterior surface, has a resiliency defined as a Shore 00 durometer of less than about 10; and
28. The mask of claim 27, wherein the attaching member is less resilient than the seal.
29. The mask of claim 27, further comprising means for strengthening the wall portion of the seal.
30. The mask of claim 27, wherein the seal has a generally triangular shape.
31. The mask of claim 27, wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion, including the first exterior surface, the second exterior surface and the third exterior surface, has a resiliency defined as a Shore 000 durometer of from about 20 to about 45.
32. The mask of claim 27, wherein he pliable material is a viscoelastic material such that the unitary solid structure exhibits viscoelasticity.
33. The mask of claim 32, wherein the viscoelastic material is a gel substance comprising a viscoelastic polyurethane polymer.
34. A facial seal adapted to be coupled to a mask shell, the facial seal comprising:
a wall portion extending between the mask shell attaching portion and the patient portion structurally supporting the patient portion relative to the mask shell attaching portion and defining a cavity adapted to receive at least a portion of such a user's nose, wherein the mask shell attaching portion, the patient portion, and the wall portion are all part of a single, unitary solid structure formed at least partially from a pliable viscoelastic material such that the unitary solid structure exhibits viscoelasticity and recoils back to substantially its original shape when not stressed, wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion has a resiliency defined as a Shore 00 durometer of less than about 10, and wherein the mask shell attaching portion, the patient portion, and the wall portion include a protective covering provided on an exterior surface thereof having a thickness and a pliability causing the protective covering to have a negligible durometer.
35. The facial seal of claim 34, wherein the patient portion is provided at a first end of the wall portion and the mask shell attaching portion is provided at a second end portion of the wall portion, wherein the mask shell attaching portion is adapted to attach to a body of a respiratory mask, and wherein the patient portion is contoured.
36. The facial seal of claim 35, further comprising an attachment mechanism integrally molded into mask shell attaching portion for attaching the mask shell attaching portion to the body of the respiratory mask, wherein the attachment mechanism is less resilient than the mask shell attaching portion.
37. The facial seal of claim 34, further comprising means for strengthening the wall portion of the seal.
38. The facial seal of claim 34, wherein the seal has a generally triangular shape.
39. The facial seal of claim 34, wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion has a resiliency defined as a Shore 000 durometer of from about 20 to about 45.
40. The facial seal of claim 34, wherein the viscoelastic material is a gel substance comprising a viscoelastic polyurethane polymer.
41. A respiratory mask comprising:
(3) a wall portion extending between the mask shell attaching portion and the patient portion structurally supporting the patient portion relative to the mask shell attaching portion and defining a cavity adapted to receive at least a portion of such a user's nose, wherein the mask shell attaching portion, the patient portion, and the wall portion are all part of a single, unitary solid structure formed from a pliable viscoelastic material such that the unitary solid structure exhibits viscoelasticity and recoils back to substantially its original shape when not stressed, wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion has a resiliency defined as a Shore 00 durometer of less than about 10, and wherein the mask shell attaching portion, the patient portion, and the wall portion include a protective covering provided on an exterior surface thereof having a thickness and a pliability causing the protective covering to have a negligible durometer; and
42. The mask of claim 41, wherein the attaching member is less resilient than the seal.
43. The mask of claim 42, further comprising means for strengthening the wall portion of the seal.
44. The mask of claim 41, wherein the seal has a generally triangular shape.
45. The mask of claim 41, wherein the entirety of the mask shell attaching portion, the patient portion, and the wall portion has a resiliency defined as a Shore 000 durometer of from about 20 to about 45.
46. The mask of claim 41, wherein the viscoelastic material is a gel substance comprising a viscoelastic polyurethane polymer.
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