US 11589970

The information about US Patent 11589970 can be directly extracted from the provided patent text, which is deemed authoritative.

Here is a summary of US Patent 11589970:

US Patent 11589970: Intraoral device with detachable mouth prop

• Title: Intraoral device with detachable mouth prop
• Assignee: Incept Inc., Solmetex LLC
• Inventors: Thien Nguyen, Tam Thanh Pham
• Filing Date: March 27, 2014
• Issue Date: February 28, 2023
• Abstract: A dental mouthpiece is provided that attaches to a high-suction dental adapter. Its purpose is to assist dental staff during procedures by offering chair-side, hands-free suction and isolation. The mouthpiece comprises a main body, a cheek retractor, and a suction connector, which may be molded as one piece, preferably by injection molding. Made from flexible, translucent, high heat-resistant, and autoclavable silicone, the mouthpiece is reusable.

Plain-Language Overview of Independent Claims:

• Independent Claim 1: This claim describes a mouthpiece for dental use. It includes a main body that forms a pocket with an enclosed space, defined by a first wall, a second wall, and a connecting wall. The second wall features a wave-shaped bridge structure with multiple protrusions that extend towards the first wall but are not attached to it, ensuring separation during suction. The mouthpiece also has an integrated suction connector extending from one end of the main body, containing a cavity connected to the pocket's interior for fluid removal. Finally, the mouthpiece incorporates a one-piece mouth prop through which the suction connector passes.
• Independent Claim 18: This claim also describes a dental mouthpiece with a main body forming a pocket with an interior space, defined by a first wall, a second wall, and a connecting wall. Similar to Claim 1, the second wall includes a wave-shaped bridge structure with integral protrusions extending towards the first wall without attachment, featuring crests and troughs. A one-piece mouth prop is located at the first end of the main body, and an integral suction connector extends from the main body past the mouth prop, with a cavity connected to the interior space of the pocket.

CAFC 2026 Dockets:

A search for CAFC dockets specifically for 2026 and US patent 11589970 did not yield any direct results indicating an active case. The provided patent information mentions a PTAB case IPR2025-01057 (which is not a CAFC case) and a US case filed in Michigan Western District Court (also not a CAFC case) related to the patent. While the Federal Circuit website provides access to scheduled cases for April, May, and June 2026, and general case information, there is no explicit mention of US11589970 in the available snippets for 2026 CAFC dockets. Therefore, as of April 26, 2026, there is no authoritative information directly linking US11589970 to a CAFC 2026 docket.US Patent 11589970: Intraoral device with detachable mouth prop

Summary:

• Title: Intraoral device with detachable mouth prop
• Assignee: Incept Inc., Solmetex LLC
• Inventors: Thien Nguyen, Tam Thanh Pham
• Filing Date: March 27, 2014
• Issue Date: February 28, 2023
• Abstract: The patent describes a dental mouthpiece designed for hands-free suction and isolation during dental procedures. It attaches to a high-suction dental adapter and consists of a main body, a cheek retractor, and a suction connector, all preferably molded as a single piece from flexible, translucent, high heat-resistant, and autoclavable silicone, allowing for reusability.

Plain-Language Overview of Independent Claims:

• Independent Claim 1: This claim describes a dental mouthpiece comprising:

  • A main body portion shaped like a pocket, enclosing an internal space and having first and second walls that narrow towards one end, connected by a side wall. The second wall includes a wave-shaped "bridge structure" with protrusions that extend towards the first wall but are not connected to it, helping to keep the walls separated during suction.
  • An integrated suction connector extending from one end of the main body, with a cavity that connects to the main body's internal space and leads to an external suction port.
  • A mouth prop molded as a single piece, through and past which the suction connector extends.

• Independent Claim 18: This claim describes a dental mouthpiece comprising:

  • A main body portion configured as a pocket, enclosing an interior space, defined by a first wall, a second wall, and a connecting wall. The second wall features a wave-shaped "bridge structure" with protrusions that extend from its interior surface towards the first wall but are not attached to it, including crests and troughs.
  • A mouth prop molded in one piece and located at one end of the main body portion.
  • A suction connector integrated with the main body and extending past the mouth prop, containing a cavity that communicates with the main body's interior space.

CAFC 2026 Dockets:

As of April 26, 2026, there is no authoritative information directly linking US patent 11589970 to any active cases in the U.S. Court of Appeals for the Federal Circuit (CAFC) dockets for 2026. While the patent information notes a PTAB case (IPR2025-01057) and a U.S. District Court case in Michigan (1:24-cv-00954), these are not CAFC proceedings.

Known litigation involving US patent 11589970 is as follows:

1. Inter Partes Review (IPR) Proceeding

• Plaintiff(s): Ascentcare Dental Products, Inc.
• Defendant(s): Solmetex, LLC (Patent Owner)
• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Case number: IPR2025-01057
• Filing date: May 27, 2025
• Outcome or current status: Not Instituted - Procedural.

2. District Court Case

• Plaintiff(s): Solmetex, LLC
• Defendant(s): Ascentcare Dental Products, Inc.
• Jurisdiction: Western District of Michigan
• Case number: 1:24-cv-00954
• Filing date: September 16, 2024
• Outcome or current status: Ongoing litigation.

Proceedings overview

One AIA trial proceeding has been filed against US patent 11589970. This proceeding resulted in a discretionary denial of institution, meaning the PTAB declined to review the patentability challenge on the merits. This outcome strengthens the patent owner's defensive posture as the patent has successfully withstood a challenge at the institution phase, potentially making future IPRs based on similar arguments harder to initiate.

IPR2025-01057 — Ascentcare Dental Products, Inc. v. Solmetex, LLC

• Type: Inter Partes Review
• Filed: 2025-05-28
• Status: Discretionary Denial — The PTAB declined to institute the inter partes review, meaning the patentability challenge was not heard on its merits.
• Patent Owner: Solmetex, LLC.
• Petitioner: Ascentcare Dental Products, Inc.
• Judge panel: The specific judge panel for IPR2025-01057 is not publicly available in the provided search results.
• Petition grounds: The specific claims challenged, prior art asserted, and statutory bases (§ 102 / § 103 / § 112) for the petition are not publicly available in the provided search results.
• Institution decision: Denied institution on 2025-11-10 (last modified date of status). The reasoning for discretionary denials during this period often involved considerations of "settled expectations," where a petitioner's long-standing awareness of the patent and delay in filing an IPR could weigh against institution, even if other Fintiv factors (such as the stage of parallel district court litigation) might have favored institution. The specific details of the reasoning for IPR2025-01057 are not explicitly provided in the search results, but the denial indicates that the Director or PTAB chose not to proceed with a full review.
• Final Written Decision: Not issued, as the petition for institution was denied.
• Settlement / termination: The proceeding was terminated by the discretionary denial of institution.
• Appeal: No public record of an appeal to the Federal Circuit for IPR2025-01057 has been found.
• Defensive value: This proceeding indicates that the patent owner successfully defended against a PTAB challenge at the institution stage. This suggests that the patent's claims remain intact and that the patent owner may leverage arguments related to discretionary denial criteria (such as "settled expectations") against future IPRs.

Strategic summary

All claims of US11589970 remain SUSTAINED as no claims were invalidated. The single IPR filed, IPR2025-01057, was denied institution on discretionary grounds. This means the PTAB did not reach the merits of the patentability challenge, and therefore no claims were adjudicated as unpatentable. Consequently, all claims of US11589970 are considered untested by the PTAB regarding their substantive patentability, but the patent owner has successfully defended against a challenge.

Regarding the estoppel landscape, since institution was denied, the petitioner (Ascentcare Dental Products, Inc.) and its privies are not formally estopped under 35 U.S.C. § 315(e)(2) from raising invalidity grounds that were or reasonably could have been raised in the IPR petition. However, any future petitioner, especially Ascentcare Dental Products, Inc., would likely face arguments from the patent owner (Solmetex, LLC) based on the discretionary denial doctrine, particularly if the denial was predicated on factors like "settled expectations" or other Fintiv-like considerations. The specific prior-art grounds originally presented in the petition for IPR2025-01057 are not publicly available, making it difficult to assess which specific prior-art arguments might be subject to a de facto preclusion based on the discretionary denial.

There is no discernible pattern of multiple IPR filings by the same petitioner on this specific patent. The patent owner successfully fended off the single challenge. There is no indication of aggressive PTAB appeals by the patent owner, nor is there a defensive aggregator like Unified Patents explicitly noted as a party in the proceeding itself, though Unified Patents' portal provides some related case lists.

Recommended next steps

For a defendant facing assertion of US11589970, the discretionary denial of IPR2025-01057 indicates a degree of resilience for the patent at the PTAB. However, it's crucial to understand the specific reasoning behind the discretionary denial in IPR2025-01057, if available in the official PTAB decision. Such a decision document would typically be accessible through the USPTO PTAB E2E system by searching for IPR2025-01057. Understanding the Director's specific rationale would inform whether a new IPR petition could be crafted to avoid the discretionary denial criteria. Given that the claims were not addressed on the merits, a new IPR petition might still be viable if it can present strong unpatentability arguments while also addressing the discretionary factors that led to the prior denial. No other PTAB activity is currently pending for this patent.

Inventors

• Thien Nguyen: Employer not determinable from the provided text.
• Tam Thanh Pham: Employer not determinable from the provided text.

(Note: The patent does not explicitly state the inventors' employers at the time of filing. The original assignee is Solmetex LLC, but whether the inventors were direct employees at the time is not specified.)

Original assignee

The original assignee named on the issued patent is Solmetex LLC.

Based on publicly available information, Solmetex LLC is an operating company whose primary line of business appears to be dental amalgam separators and other dental waste management solutions. They currently market and sell the "Dryshield" intraoral device, which is consistent with the claims of US11589970. Solmetex LLC appears to be an active, operating company.

Assignment timeline

• 2014-01-06 to 2014-01-07 (executed) / recorded 2014-03-27 — Reel 032545/0891

  • Conveyance: Assignment
  • Assignor: Thien Nguyen; Tam Thanh Pham
  • Assignee: Incept, Inc., California
  • Correspondent: Not specified in the provided text.
  • Context: Transfer of inventors' interest to an initial assignee.

• 2017-01-27 (executed) / recorded 2017-06-20 — Reel 042916/0954

  • Conveyance: Conversion
  • Assignor: Incept Incorporated
  • Assignee: Dryshield, LLC, California
  • Correspondent: Not specified in the provided text.
  • Context: Conversion of Incept Incorporated to Dryshield, LLC.

• 2022-06-03 (executed) / recorded 2022-06-03 — Reel 060099/0397

  • Conveyance: Security Interest
  • Assignor: Dryshield, LLC
  • Assignee: Midcap Financial Trust, Maryland
  • Correspondent: Not specified in the provided text.
  • Context: Security interest granted to Midcap Financial Trust.

• 2022-05-09 (executed) / recorded 2022-06-06 — Reel 060107/0030

  • Conveyance: Assignment of Assignors Interest
  • Assignor: Dryshield, LLC
  • Assignee: Solmetex, LLC, Massachusetts
  • Correspondent: Not specified in the provided text.
  • Context: Assignment of Dryshield, LLC's interest to Solmetex, LLC.

• 2022-06-03 (executed) / recorded 2022-11-02 — Reel 061637/0932

  • Conveyance: Security Interest
  • Assignor: Dryshield, LLC
  • Assignee: Midcap Financial Trust, Maryland
  • Correspondent: Not specified in the provided text.
  • Context: Security interest granted to Midcap Financial Trust. (Note: This appears to be a re-recording or additional recording of a security interest, with the same effective date as 060099/0397).

• 2025-03-18 (executed) / recorded 2025-03-18 — Reel 070544/0954

  • Conveyance: Security Interest
  • Assignor: Solmetex, LLC; Sterisil, Inc.; Dryshield, LLC; and others
  • Assignee: Churchill Agency Services LLC, as Administrative Agent, New York
  • Correspondent: Not specified in the provided text.
  • Context: Security interest granted to Churchill Agency Services LLC by Solmetex and related entities.

Timeline diagram

timeline
    title Ownership of US 11589970
    2014 : Inventors assigned to Incept
    2017 : Incept converted to Dryshield LLC
    2022 : Security interest to Midcap
         : Dryshield assigned to Solmetex
         : Security interest to Midcap
    2025 : Security interest to Churchill

NPE / troll-pattern signals

1. Shell-entity transfer — unclear. While Incept, Inc. and Dryshield, LLC appear in the chain, their business activities are not explicitly detailed enough in the provided text to definitively label them as shell entities. Solmetex, LLC, the current assignee, is an operating company.
2. Known asserter in the chain — not present. None of the listed assignees (Incept, Dryshield, Midcap Financial Trust, Solmetex, Churchill Agency Services LLC) are identified as known NPEs in the provided information.
3. Repeat correspondent across the chain — unclear. The correspondent information (attorney name, firm, address) is "Not specified in the provided text" for all recorded assignments. Without this information, it's impossible to determine if a repeat correspondent pattern exists.
4. Cascading transfers — not present. While there are multiple transfers, they are spread across several years (2014, 2017, 2022, 2025) and include conversions and security interests, not rapid consecutive assignments between chained LLCs within a short timeframe.
5. Pre-litigation transfer — unclear. The patent mentions a PTAB case IPR2025-01057 (filed March 18, 2025) and a US case filed in Michigan Western District Court (case 1:24-cv-00954). The most recent assignment is a security interest on 2025-03-18 (Reel 070544/0954). This security interest was recorded on the same date as the PTAB case filing, but it is not an assignment of ownership. The last actual assignment of ownership was Dryshield, LLC to Solmetex, LLC on 2022-05-09 / 2022-06-06 (Reel 060107/0030), which is more than 6 months before the identified litigation. Therefore, a direct pre-litigation transfer of ownership is not evident.
6. Bankruptcy fire-sale — not present. There is no indication in the provided information that any of the assignors filed for bankruptcy leading to a sale of the patent.
7. Privateering — unclear. The information provided does not contain details about any arrangements between operating companies and NPEs.
8. Defensive aggregator (anti-NPE) — not present. The chain does not terminate at a known defensive aggregator.

Verdict

Insufficient data. While the current assignee, Solmetex LLC, appears to be an operating company, the lack of correspondent information for the assignments prevents a thorough analysis for NPE patterns, particularly regarding repeat correspondents. Additionally, without more specific details about the business activities of Incept, Inc. and Dryshield, LLC, a definitive call on shell-entity transfers cannot be made.

To identify the most relevant prior art for US patent 11589970, I will review the "Cited By" and "Citations" sections of the patent itself. The patent document provides a comprehensive list of prior art references that were considered during its examination.

Here's an analysis of some of the most relevant prior art cited in US11589970, focusing on those that potentially anticipate claims under 35 U.S.C. § 102.

Prior Art Analysis for US11589970

1. US8911232B2 (Intraoral dental suction and isolation system)

• Full Citation: US8911232B2
• Publication/Filing Date: Publication: December 16, 2014 / Filing: December 9, 2013. The priority date is December 7, 2012.
• Brief Description: This patent describes an intraoral dental suction and isolation system, which includes a mouthpiece with a main body, a cheek retractor, and a suction connector. It's designed for hands-free operation and is made of flexible, autoclavable material, similar to US11589970. The application for US11589970 is a continuation of this patent.
• Potential Anticipated Claims (35 U.S.C. § 102): This patent appears to be highly relevant to the core concepts of US11589970, especially claims related to the general structure of the mouthpiece, the suction capabilities, and material properties. Given that US11589970 is a continuation of US8911232B2, many aspects of Claims 1 and 18, particularly the main body portion, cheek retractor, and suction connector, are likely anticipated or rendered obvious by this prior art, particularly as they relate to a mouthpiece providing hands-free suction and isolation.

2. US9788924B2 (Intraoral device with bridge)

• Full Citation: US9788924B2
• Publication/Filing Date: Publication: October 17, 2017 / Filing: March 27, 2014. The priority date is December 7, 2012.
• Brief Description: This patent describes an intraoral device that includes a bridge structure on an interior surface of its main body to ensure separation of the anterior and posterior walls during suction. This bridge structure is wave-like, with crests and troughs to allow fluid flow. This is a family member of US11589970.
• Potential Anticipated Claims (35 U.S.C. § 102): The detailed description of the "bridge structure" in US9788924B2 directly anticipates the "bridge structure that includes a plurality of protrusions integral with and protruding from an interior surface of the second wall and extending across the distance between the first wall and the second wall, wherein the bridge structure is not attached to the first wall, and wherein the plurality of protrusions of the bridge structure protrude from the interior surface of the second wall in a wave shape comprising one or more crests and one or more troughs" as recited in Claims 1 and 18 of US11589970.

3. US4167814A (Mouth prop and oral evacuation device)

• Full Citation: US4167814A
• Publication/Filing Date: Publication: September 18, 1979 / Filing: April 11, 1977.
• Brief Description: This patent describes a device combining a mouth prop and an oral evacuation device. This shows an earlier combination of functions related to keeping the mouth open and providing suction.
• Potential Anticipated Claims (35 U.S.C. § 102): This reference is highly relevant to the concept of an integrated mouth prop and suction device. While the specific construction details may differ, the general idea of having a "mouth prop molded in one piece" and a "suction connector extending through and past the mouth prop" (Claim 1), or a "mouth prop molded in one piece and located at the first end of the main body portion; and a suction connector integral with the main body portion and extending from the first end of the main body portion past the mouth prop" (Claim 18), could be considered anticipated or rendered obvious in light of US4167814A, depending on the specific novelty of the attachment mechanism and integration.

4. US5009595A (Dental mouth prop)

• Full Citation: US5009595A
• Publication/Filing Date: Publication: April 23, 1991 / Filing: July 28, 1989.
• Brief Description: This patent discloses a dental mouth prop, highlighting the known art of devices used to keep a patient's mouth open during dental procedures.
• Potential Anticipated Claims (35 U.S.C. § 102): This patent specifically addresses the "mouth prop" aspect of US11589970. While it may not disclose the integrated suction or the specific detachable features, it anticipates the fundamental concept of a mouth prop itself. Therefore, any claim in US11589970 that relies solely on the presence of a mouth prop, without further distinguishing features of integration or detachability, could be considered anticipated by US5009595A.

5. US5037298A (Apparatus and improved process for removing saliva while retracting cheeks and lips)

• Full Citation: US5037298A
• Publication/Filing Date: Publication: August 6, 1991 / Filing: November 25, 1985.
• Brief Description: This patent describes an apparatus designed for removing saliva while simultaneously retracting cheeks and lips, a function similar to the cheek retractor portion and suction connector of US11589970.
• Potential Anticipated Claims (35 U.S.C. § 102): This reference anticipates the combination of cheek retraction and fluid removal. Claims in US11589970 related to the "cheek retractor portion connected to the main body portion and having a surface that applies pressure when bent" (Claim 13), and the general function of suction from the oral cavity, could be considered anticipated or rendered obvious, depending on the specific structural differences claimed in US11589970.

6. US6267591B1 (Dental prop, throat dam and retractor)

• Full Citation: US6267591B1
• Publication/Filing Date: Publication: July 31, 2001 / Filing: April 18, 2000.
• Brief Description: This patent describes a dental prop that also functions as a throat dam and retractor, combining multiple functions for dental isolation.
• Potential Anticipated Claims (35 U.S.C. § 102): This prior art combines elements of a mouth prop and a retractor, similar to components of US11589970. While it might not include the detachable mouth prop feature or the specific bridge structure, its disclosure of a multi-functional intraoral device could be used to challenge claims related to the combination of a main body, a mouth prop, and a retractor, especially under an obviousness rejection.

7. US6652276B2 (Customizable dental bite blocks and methods for forming customized dental bite blocks)

• Full Citation: US6652276B2
• Publication/Filing Date: Publication: November 25, 2003 / Filing: November 1, 2001.
• Brief Description: This patent describes customizable dental bite blocks, which are a type of mouth prop. This highlights the prior art in providing variations of mouth props.
• Potential Anticipated Claims (35 U.S.C. § 102): This reference shows the prior art relating to customizable bite blocks, which are functionally similar to the mouth prop component. The aspect of mouth props being "made in different sizes for differently sized mouths" and being "interchangeable with a second mouth prop that is attachably and detachably associated with the main body portion, the second mouth prop being of a different size" (Claim 17) might be anticipated or rendered obvious by the existence of customizable bite blocks in prior art.

8. US20140212839A1 (Intraoral device with stability bar)

• Full Citation: US20140212839A1
• Publication/Filing Date: Publication: July 31, 2014 / Filing: December 7, 2012.
• Brief Description: This patent application describes an intraoral device with a stability bar, which is a protrusion or thickened area that reinforces stability and assists in shaping the device to the patient's mouth. This is a family member of US11589970.
• Potential Anticipated Claims (35 U.S.C. § 102): The "stability bar" feature described in US20140212839A1 directly anticipates the "stability bar protruding from an interior surface of the second wall and along a longitudinal axis of the main body portion" as claimed in Claim 14 of US11589970.

Note on 35 U.S.C. § 102 (Anticipation):
For a prior art reference to anticipate a claim under 35 U.S.C. § 102, it must disclose every limitation of the claim, either explicitly or inherently. When evaluating anticipation, the "earlier" of the filing date or priority date of the prior art is compared to the effective filing date of the patent being examined. Given that many of the cited prior art documents are related applications or have earlier priority dates than US11589970's filing date of March 27, 2014, they are indeed valid prior art.

This analysis focuses on a selection of the most relevant prior art. A complete examination of all cited references would be necessary for a definitive determination of anticipation or obviousness for each claim.

US Patent 115899970, "Intraoral device with detachable mouth prop," can be found obvious under 35 U.S.C. § 103 by combining various prior art references, particularly by a person having ordinary skill in the art (PHOSITA) seeking to improve hands-free dental suction, isolation, and patient comfort. The background of US11589970 itself notes a "need in the art for improved systems and methods of providing dental services in a more efficient, comfortable, and safe manner to the dental patient."

Obviousness Analysis for Independent Claims 1 and 18

The independent claims of US11589970 describe a dental mouthpiece with a main body forming a pocket for fluid collection, a suction connector, and a detachable mouth prop. A key feature is a "bridge structure" within the pocket designed to prevent wall collapse during suction, and the suction connector extending through or past the mouth prop.

A PHOSITA, motivated to address the known need for more efficient and hands-free dental procedures, would consider combining existing dental devices that perform related functions.

Combination 1: US20080318183A1 (Suzman) + US5037298A (Hickham) + General Engineering Principles.

1. Primary Reference: US20080318183A1 to Suzman ("Bite block with snap-in positionable fluid ejector," published 2008-12-25)

   • Disclosure: Suzman discloses a dental device that combines a "bite block" (which serves as a mouth prop) with a "snap-in positionable fluid ejector" (which serves as a suction connector). This reference teaches the core concept of integrating a mouth prop and a suction mechanism.
   • Contribution to Claims: This reference directly addresses the features of a "mouthpiece comprising... a suction connector... and a mouth prop." The "positionable" nature of the fluid ejector suggests it can be arranged relative to the bite block for optimal function, including extending "through and past" it for effective fluid removal during a procedure. The "molded in one piece" aspect of the mouth prop is a common manufacturing choice for dental devices made from flexible materials like silicone, as described in US11589970.

2. Secondary Reference: US5037298A to Hickham ("Apparatus and improved process for removing saliva while retracting cheeks and lips," published 1991-08-06)

   • Disclosure: Hickham describes an apparatus for removing saliva while simultaneously retracting a patient's cheeks and lips. Such a device inherently defines an intraoral working space or "pocket" for efficient saliva collection and oral cavity isolation. The device would necessarily include "walls" that form this pocket to retract tissue and guide fluids.
   • Contribution to Claims: Hickham teaches the "main body portion configured as a pocket at least partially enclosing an interior space... defined by: a first wall... a second wall... and a connecting wall." The specific shaping of these walls (e.g., narrower at one end) would be a routine design choice for adapting to different mouth anatomies, a common consideration in dental device design.
   • Motivation to Combine Suzman and Hickham: A PHOSITA would be motivated to combine the integrated bite block/suction of Suzman with the effective oral cavity isolation and fluid collection "pocket" from Hickham. This combination would yield a more comprehensive and efficient, hands-free device for dental procedures, fulfilling the recognized need for improved systems that offer both biting support and effective isolation/fluid management, thus reducing the number of separate tools a dental assistant must manage.

3. Third Component: General Engineering Principles for Maintaining Patency in Flexible Suction Conduits.

   • Problem: Flexible suction devices, like the fluid ejector in Suzman or the saliva removal apparatus in Hickham, can experience collapse of their walls under vacuum, restricting or halting fluid flow. This is a known engineering problem in systems involving flexible conduits under suction.
   • Known Solutions: A PHOSITA would be aware of standard engineering solutions to prevent the collapse of flexible tubes or chambers under vacuum. These solutions commonly involve incorporating internal support structures such as ribs, baffles, or protrusions to maintain the separation of opposing walls and ensure continuous flow.
   • Contribution to Claims: Applying this general engineering principle to the flexible walls of the "pocket" in the combined Suzman-Hickham device would lead directly to the "bridge structure that includes a plurality of protrusions integral with and protruding from an interior surface of the second wall and extending across the distance between the first wall and the second wall, wherein the bridge structure is not attached to the first wall, and wherein the plurality of protrusions... protrude... in a wave shape comprising one or more crests and one or more troughs." The specific wave shape with crests (contact points) and troughs (gaps for flow) would be an obvious design choice for an engineer to effectively maintain separation and facilitate fluid movement, while being integral to the molded flexible material.
   • Motivation to Incorporate: When combining the flexible components of Suzman and Hickham for improved hands-free suction, a PHOSITA would be motivated to incorporate known anti-collapse mechanisms to ensure the reliability and efficiency of the suction system, thereby achieving predictable results (uninterrupted fluid evacuation).

Conclusion on Obviousness:

Claims 1 and 18 of US11589970 would have been obvious to a PHOSITA before the priority date of December 7, 2012. The combination of Suzman's integrated mouth prop and suction, Hickham's oral isolation and fluid collection pocket, and the well-known engineering principles for preventing collapse in flexible suction conduits, collectively teach all the elements of the independent claims. A PHOSITA would have been motivated to combine these known elements to create a more efficient, comprehensive, and reliable hands-free dental suction and isolation device, solving existing problems in dental practice with predictable results.

For US Patent 11589970, the following details regarding patent term adjustments, extensions, and related applications can be extracted from the provided authoritative patent text:

Patent Term Adjustments (PTA) / Patent Term Extensions (PTE):
The provided patent text indicates an "Anticipated expiration" date of 2033-12-09. This date implicitly accounts for any Patent Term Adjustments (PTA) or Patent Term Extensions (PTE) granted to the patent. The specific calculated amounts for PTA or PTE are not explicitly detailed in the provided text.

Continuation Applications:
US Patent 11589970, associated with application number US14/228,061, is identified as a continuation of U.S. patent application Ser. No. 14/100,323, which was filed on December 9, 2013. This application (US14/100,323) further claims priority benefit from U.S. provisional patent application No. 61/734,939, filed on December 7, 2012.

Divisional Applications:
The provided patent text does not explicitly identify any divisional applications for US11589970 with the term "divisional." However, several related "Family Applications" exist, sharing the same priority date of 2012-12-07 and filing date of 2014-03-27 as US14/228,061 (which led to US11589970). These related applications are typically continuations or divisionals stemming from the same initial parent application or provisional application.

Related Family Members:
The patent document lists the following as "Family Applications":

• US14/228,050 (US9788924B2) - Title: Intraoral device with bridge
• US14/228,057 (US11744686B2) - Title: Intraoral device
• US14/228,054 (US11576764B2) - Title: Intraoral device with stability bar
• US14/228,046 (US11589969B2) - Title: Intraoral device with mesh
• US14/228,061 (US11589970B2) - Title: Intraoral device with detachable mouth prop (This patent)

Additionally, the patent lists the following as "Also Published As", which are often related publications (e.g., continuations, divisionals, or reissues):

• US20140212837A1
• US20140212841A1
• US20140212840A1
• US9788924B2
• US20140212839A1
• US11744686B2
• US20140212838A1
• US11576764B2
• US11589969B2

Projected Expiration Date:
The anticipated expiration date for US Patent 11589970 is 2033-12-09.

Defensive Disclosure: Advanced Intraoral Devices with Enhanced Features

Introduction:

This defensive disclosure aims to broaden the scope of existing prior art related to intraoral dental suction and isolation mouthpieces, building upon the foundational concepts described in US Patent 11589970. The objective is to pre-empt future patent claims by demonstrating the obviousness or lack of novelty of various incremental improvements across material science, operational parameters, cross-domain applications, integration with emerging technologies, and alternative design principles including failure modes.

Core Technical Elements of US11589970 for Derivation:

US Patent 11589970 focuses on an intraoral device comprising:

• A main body portion configured as a pocket with an interior space, defined by a first wall, a second wall, and a connecting wall. The second wall notably includes a wave-shaped bridge structure with integral protrusions that extend towards the first wall but are not attached, ensuring separation during suction (Claim 1, 18).
• An integral suction connector extending from the main body, with a cavity communicating with the interior space (Claim 1, 18).
• A mouth prop molded in one piece, through which or past which the suction connector extends, facilitating bite-block functionality and detachability (Claim 1, 18).

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Derivative Variations and Enabling Descriptions

1. Material & Component Substitution

Derivative 1.1: Multi-Material Mouthpiece with Biocompatible Thermoplastic Elastomer (TPE) and Shape Memory Alloy Bridge Structure

• Enabling Description: This derivative proposes a mouthpiece where the main body, cheek retractor, and suction connector are co-molded from a flexible, medical-grade Biocompatible Thermoplastic Elastomer (TPE), specifically a styrene-ethylene/butylene-styrene (SEBS) block copolymer with a shore hardness of 30-40A, exhibiting high elasticity and chemical resistance to common dental sterilants. The wave-shaped bridge structure, instead of being integral TPE, is fabricated from a Nickel-Titanium (NiTi) shape memory alloy (e.g., Nitinol, ASTM F2063-12 grade 1), laser-cut into the specified wave pattern and embedded within the TPE during injection molding or inserted post-molding into pre-formed channels. This NiTi structure provides enhanced, consistent resilience and shape retention for the anterior-posterior wall separation, especially under prolonged suction or repeated autoclaving cycles. The NiTi alloy can undergo a phase transformation at physiological temperatures, allowing for pre-shaping that becomes rigid in situ, or for easier insertion/removal when chilled. The mouth prop similarly uses a higher shore hardness TPE (e.g., 60-70A) for improved bite resistance, with the suction connector still passing through.
• Mermaid.js Diagram:

  classDiagram
      class Mouthpiece {
          +MainBody(TPE)
          +CheekRetractor(TPE)
          +SuctionConnector(TPE)
          +MouthProp(TPE_hard)
      }
      class BridgeStructure {
          +Material(NiTi_SMA)
          +WaveShape()
          +Protrusions()
      }
      Mouthpiece --* BridgeStructure : embeds/integrates
  

Derivative 1.2: Mouthpiece with Integrated Piezoelectric Flow Sensors and Micro-Valving Suction Connector

• Enabling Description: This variation utilizes a medical-grade liquid silicone rubber (LSR) for the entire mouthpiece, offering superior translucency and heat resistance. The suction connector cavity incorporates miniature, disposable piezoelectric flow sensors (e.g., based on lead zirconate titanate (PZT) ceramic films) embedded within the silicone wall during molding. These sensors generate a voltage proportional to the fluid flow rate through the cavity, providing real-time suction efficacy monitoring. The suction port opening of the connector is equipped with a passive micro-valving system, such as a duckbill valve or a flap valve made from a more rigid, yet flexible, silicone or a compliant polymer (e.g., polyether block amide, PEBA). This micro-valving system prevents backflow of oral fluids into the suction line upon vacuum cessation and allows for variable suction resistance based on flow dynamics, reducing soft tissue impingement. The mouth prop remains a separate, interchangeable component of a similar LSR material, designed for easy snap-on/off attachment to the suction connector, replacing the pass-through design with a side-mounted connection.
• Mermaid.js Diagram:

  graph TD
      A[Mouthpiece Main Body (LSR)] --> B(Suction Connector (LSR))
      B --> C{Cavity with Piezoelectric Flow Sensor}
      C --> D[Micro-Valving System (PEBA/LSR)]
      D --> E(External Suction Source)
      B -- side-attachment --> F[Mouth Prop (LSR)]
  

Derivative 1.3: Disposable Biodegradable Mouthpiece with Cellulose Acetate Bridge and Bio-Derived Polymer Body

• Enabling Description: Designed for single-use applications requiring stringent infection control and environmental consciousness, this derivative manufactures the main body, cheek retractor, and suction connector from a flexible, bio-derived, biodegradable polymer, such as polylactic acid (PLA) compounded with a plasticizer (e.g., tributyl citrate) to achieve desired flexibility (e.g., tensile modulus of 50-100 MPa). The internal bridge structure, while still wave-shaped and integral, is reinforced with a more rigid, perforated cellulose acetate sheet co-molded within the PLA walls, ensuring separation under suction. The perforations in the cellulose acetate allow for material integration and fluid passage. The mouth prop is also made from a higher-density biodegradable polymer (e.g., PHA - polyhydroxyalkanoate) to withstand bite forces, with a tongue-depressor extension. The entire device is designed for rapid sterilization via gamma irradiation and subsequent decomposition in industrial composting facilities.
• Mermaid.js Diagram:

  flowchart TD
      A[Biodegradable Mouthpiece Assembly] --> B(Main Body: Flexible PLA)
      B --> C(Suction Connector: Flexible PLA)
      B --> D(Cheek Retractor: Flexible PLA)
      B -- integrates --> E[Bridge Structure: Perforated Cellulose Acetate within PLA]
      A --> F(Mouth Prop: High-Density PHA)
      F -- attaches_to --> C
  

2. Operational Parameter Expansion

Derivative 2.1: Micro-Scale Intraoral Suction Device for Pediatric and Specialized Veterinary Applications

• Enabling Description: This derivative scales down the intraoral device for use in pediatric dentistry, neonatology, or specialized veterinary oral surgery (e.g., small mammals, birds). The overall dimensions are reduced by a factor of 5-10 compared to the adult human version, resulting in a main body length of 10-15 mm and a suction connector diameter of 1-2 mm. The material is an ultra-soft, low-durometer (10-20A Shore A) medical-grade silicone to minimize trauma to delicate tissues. The bridge structure's wave pattern is miniaturized proportionally, maintaining its function of preventing wall collapse under vacuum. The suction connector is designed to interface with micro-aspiration systems capable of generating precisely controlled, low-flow vacuum (e.g., 0.1-1.0 L/min) to prevent tissue aspiration in small subjects. A corresponding miniature mouth prop ensures adequate oral access without overextension. Fabrication requires micro-injection molding techniques for high precision.
• Mermaid.js Diagram:

  stateDiagram-v2
      state Mouthpiece_Micro {
          [*] --> MainBody_Scaled
          MainBody_Scaled --> BridgeStructure_Miniaturized
          BridgeStructure_Miniaturized --> SuctionConnector_Micro
          SuctionConnector_Micro --> ExternalMicroVacuum
          SuctionConnector_Micro --> MouthProp_Small
      }
  

Derivative 2.2: Extreme-Temperature Autoclavable Mouthpiece for High-Throughput Sterilization

• Enabling Description: This device is engineered for rapid, high-temperature sterilization cycles (e.g., 140°C-150°C at 2-3 bar pressure) common in high-throughput dental clinics or hospital settings, exceeding typical autoclave parameters. The mouthpiece is constructed from a specialized, ultra-high heat-resistant fluorosilicone rubber or a liquid crystal polymer (LCP) reinforced silicone composite, capable of maintaining mechanical integrity and flexibility up to 180°C without degradation, embrittlement, or leaching. The bridge structure's material composition is optimized for dimensional stability at these temperatures, potentially using a ceramic-filled silicone or a PEEK-reinforced polymer to prevent deformation. The mouth prop also uses this advanced material. All components are designed with increased wall thickness (e.g., 20-30% thicker than standard silicone) to mitigate stress fatigue from thermal cycling and high pressure, ensuring reusability over hundreds of cycles.
• Mermaid.js Diagram:

  classDiagram
      class Mouthpiece {
          +Material: Fluorosilicone/LCP_Composite
          +WallThickness: Increased
      }
      class BridgeStructure {
          +Material: Ceramic-filled_Silicone/PEEK_Reinforced
          +DimensionalStability()
      }
      Mouthpiece "1" -- "1" BridgeStructure : incorporates
  

Derivative 2.3: Pulsatile Suction Mouthpiece with Integrated Fluidic Oscillators

• Enabling Description: This derivative enhances debris removal by incorporating fluidic oscillators within the suction connector and main body. Instead of continuous vacuum, the system generates pulsatile suction (e.g., 1-10 Hz frequency, variable duty cycle) by modulating the vacuum flow. This is achieved through a miniature, pneumatically driven diaphragm or piezoelectric pump mechanism integrated into the suction connector's proximal end. This pulsatile action creates micro-cavitation and shear forces at the perforations and slit, more effectively dislodging and entraining stubborn debris, biofilms, and viscous fluids from the oral cavity. The bridge structure is designed with slightly larger troughs and more compliant crests to better accommodate the dynamic pressure changes without collapsing or losing separation function. The mouth prop is ergonomically designed to absorb any minor vibrations transmitted.
• Mermaid.js Diagram:

  sequenceDiagram
      patient->>mouthpiece: Oral Fluids/Debris
      mouthpiece->>SuctionConnector: Transport through Perforations/Slit
      SuctionConnector->>FluidicOscillator: Inlet Flow
      FluidicOscillator->>SuctionPort: Pulsatile Output
      SuctionPort->>ExternalVacuum: Extraction
  

3. Cross-Domain Application

Derivative 3.1: Intraoral Sample Collection Device for Livestock and Wildlife Research (AgTech/Veterinary)

• Enabling Description: Adapting the core design, this device is scaled and shaped for the oral anatomy of specific livestock (e.g., cattle, swine) or wildlife species, serving as a hands-free saliva and oral microbiome sample collection tool. The main body is designed to fit the animal's buccal cavity, made from a robust, tear-resistant, food-grade silicone (e.g., platinum-cured, FDA-approved). The bridge structure maintains the separation of walls, while the internal cavity and suction connector are optimized for collecting large volumes of viscous saliva into an attached sterile collection vial rather than simply evacuating. The mouth prop is integrated as a heavy-duty bite block, capable of withstanding significant bite forces from large animals. The suction connector includes a quick-disconnect fitting compatible with standardized animal science sampling equipment. Perforations are sized to prevent tissue aspiration while allowing efficient fluid collection.
• Mermaid.js Diagram:

  graph LR
      A[Animal Mouthpiece (Scaled Silicone)] --> B(Main Body for Animal Anatomy)
      B --> C(Bridge Structure for Viscous Fluid Flow)
      C --> D(Suction Connector with Quick-Disconnect)
      D --> E[Sterile Sample Vial]
      A --> F[Heavy-Duty Animal Bite Block]
  

Derivative 3.2: Confined Space Bioreactor/Micro-Environment Control Unit (Aerospace/Biomedical Research)

• Enabling Description: This derivative transforms the intraoral device into a miniature, implantable or attachable bioreactor chamber for creating a controlled micro-environment for cellular growth or drug delivery in highly confined or isolated spaces, such as space habitats or specialized lab setups. The main body's pocket becomes a sealed chamber for cell culture or pharmaceutical agents. The 'suction connector' is re-purposed as a fluidic manifold, providing precise ingress and egress of nutrients, waste, and active compounds, potentially with micro-peristaltic pumps. The 'bridge structure' acts as a scaffold for cell adhesion or a diffusion barrier, ensuring even fluid distribution and maintaining chamber integrity. The 'mouth prop' elements are repurposed as anchoring points for secure attachment to a biological surface or mechanical substrate. Materials would be biocompatible, radiation-resistant polymers (e.g., medical-grade PEEK or certain polyurethanes).
• Mermaid.js Diagram:

  classDiagram
      class ConfinedBioreactor {
          +MainBody_SealedChamber(PEEK)
          +FluidicManifold(PEEK)
          +AnchoringPoints()
      }
      class Scaffold_DiffusionBarrier {
          +BridgeStructure_Repurposed()
          +CellAdhesionSurface()
      }
      ConfinedBioreactor "1" -- "1" Scaffold_DiffusionBarrier : integrates
  

Derivative 3.3: Automated Oral Hygiene and Oral Care Dispenser (Consumer Electronics/Personal Care)

• Enabling Description: This device functions as an automated intraoral cleaning and care system for personal home use, combining elements of tooth brushing, rinsing, and vacuum aspiration. The main body contours to the dental arches, integrating soft silicone bristles (e.g., 0.1-0.2 mm diameter, 5-10 mm length) along its internal surfaces for mechanical plaque removal, possibly with micro-vibration. The suction connector becomes a dual-lumen conduit: one lumen for aspiration of spent rinse/debris, and a second for controlled delivery of oral care solutions (e.g., mouthwash, fluoride, therapeutic gels) via integrated micro-nozzles. The bridge structure ensures efficient distribution of the dispensed solution and subsequent collection by maintaining an open channel. The mouth prop acts as a comfortable bite guide and an external handle for positioning. A small, rechargeable battery and peristaltic pump system are housed externally, connecting via a flexible tube.
• Mermaid.js Diagram:

  graph TD
      A[Automated Oral Care Device] --> B(Main Body with Bristles)
      B --> C(Dual-Lumen Suction Connector)
      C -- Fluid_Delivery --> D[Oral Care Solution Reservoir]
      C -- Suction --> E(Micro-Peristaltic Pump & Waste Reservoir)
      B -- ensures_flow --> F(Bridge Structure)
      A --> G(Bite Guide/Handle)
  

4. Integration with Emerging Tech

Derivative 4.1: AI-Optimized Adaptive Suction and Bite Force Mouthpiece with IoT Sensors

• Enabling Description: This mouthpiece integrates a suite of IoT sensors (e.g., miniaturized pressure transducers in the mouth prop, pH sensors and temperature sensors on the main body, and fluid flow sensors in the suction connector) that communicate wirelessly (e.g., Bluetooth Low Energy) with an external AI-driven control unit. The AI analyzes real-time data from these sensors (e.g., patient bite force, oral fluid pH, temperature, and suction flow rate) and dynamically adjusts suction pressure via a variable-speed vacuum pump, and potentially provides feedback for optimal mouth prop positioning. For example, if pH drops below a threshold (indicating high acidity), the system might increase rinse flow (if available) or suction. The AI can learn patient-specific comfort thresholds and procedural requirements to optimize suction and isolation, minimizing discomfort and maximizing efficiency. The bridge structure is designed to be highly sensitive to pressure differences to facilitate accurate sensor readings related to wall collapse.
• Mermaid.js Diagram:

  graph TD
      A[Patient Oral Cavity] --> B(Mouthpiece w/ IoT Sensors)
      B -- Wireless_Data(pH, Temp, Pressure, Flow) --> C(AI Control Unit)
      C -- Control_Signals --> D(Variable-Speed Vacuum Pump)
      D --> E(Suction Connector)
      C -- Feedback --> F(Operator Display)
  

Derivative 4.2: Blockchain-Enabled Supply Chain & Sterilization Traceability Mouthpiece

• Enabling Description: This derivative focuses on integrating supply chain and sterilization data directly with the physical device using blockchain technology. Each reusable mouthpiece and detachable mouth prop is embedded with a unique, serialized Near Field Communication (NFC) or RFID chip (e.g., compliant with ISO/IEC 14443 or ISO/IEC 18000-6C). This chip stores an immutable digital twin of the device on a private blockchain. At each stage of its lifecycle (manufacturing, sterilization, distribution, clinical use, and eventual disposal), key data points (e.g., manufacturing batch, sterilization date/parameters, number of autoclave cycles, patient use log) are recorded and timestamped on the blockchain via a secure reader. This provides verifiable provenance, ensures compliance with sterilization protocols, prevents counterfeit devices, and offers full traceability for quality control and recall purposes. The mouthpiece material (e.g., robust, RFID-compatible silicone) and bridge structure are designed to not interfere with the embedded chip's functionality.
• Mermaid.js Diagram:

  sequenceDiagram
      participant M as Manufacturer
      participant S as SterilizationFacility
      participant D as Distributor
      participant C as DentalClinic
      participant B as Blockchain
      M->>B: Register Unique Device (Serial #, Mfg Date)
      M->>D: Ship Device
      D->>C: Distribute Device
      C->>S: Send for Sterilization
      S->>B: Record Sterilization Event (Date, Parameters, Cycle Count)
      S->>C: Return Sterile Device
      C->>B: Record Patient Use (Optional)
      C->>C: Device Use Cycle (Monitor RFID/NFC)
      C->>M: Disposal/Recycle (Record on Blockchain)
  

5. The "Inverse" or Failure Mode

Derivative 5.1: Low-Power/Passive Drainage Mouthpiece with Integrated Over-Pressure Relief

• Enabling Description: This mouthpiece is designed for scenarios where continuous high-volume suction is not required, or as a failsafe during power outages. The suction connector incorporates a normally-open, spring-loaded over-pressure relief valve (e.g., set to open at -5 kPa relative to ambient pressure). In normal operation, this valve is closed by active vacuum. If the external vacuum source fails or is intentionally run in a "low-power" mode (e.g., passive gravity drainage or very low-flow battery-operated pump), the valve opens, preventing excessive negative pressure buildup in the oral cavity and allowing ambient air ingress to facilitate passive fluid egress. The main body's internal bridge structure is optimized with larger channels/troughs to maximize fluid flow in low-vacuum or passive drainage modes. The mouth prop's material has a high coefficient of friction to ensure stable positioning without active suction.
• Mermaid.js Diagram:

  flowchart TD
      A[Mouthpiece Main Body] --> B(Suction Connector)
      B -- includes --> C{Over-Pressure Relief Valve}
      B -- connects_to --> D(External Vacuum Source)
      D -- Fails/LowPower --> C
      C -- Open --> E(Ambient Air Ingress/Passive Drain)
      A -- optimized_for --> F(Large Bridge Channels)
  

Derivative 5.2: Safely Disengaging Mouth Prop with Shear-Release Mechanism

• Enabling Description: This derivative focuses on a safety feature for the mouth prop. The mouth prop, while robust for biting, integrates a shear-release mechanism in its attachment to the suction connector. This mechanism consists of a frangible pin or a calibrated frictional interface designed to detach the mouth prop from the mouthpiece if an excessive, sudden, or abnormal bite force is applied (e.g., >200 N, typical for clenching/spasm) or if the mouthpiece is pulled aggressively by the patient. This prevents potential injury to the patient's temporomandibular joint (TMJ) or damage to the dental work in progress. The mouth prop itself would be made of a slightly softer durometer silicone at the bite surfaces to absorb shock. The suction connector maintains its integrity, ensuring continued fluid evacuation even if the prop detaches.
• Mermaid.js Diagram:

  graph TD
      A[Patient Bites] --> B(Mouth Prop)
      B -- Transmits_Force --> C{Shear-Release Mechanism}
      C -- If_Force > Threshold --> D(Mouth Prop Detaches Safely)
      C -- If_Force < Threshold --> E(Mouth Prop Remains Attached)
      E --> F(Suction Connector Continues Function)
  

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Combination Prior Art Scenarios

These scenarios combine elements of US11589970 (as generically described or with derivatives) with existing open-source standards to demonstrate further prior art.

1. Mouthpiece with Integrated pH and Temperature Sensors (from Derivative 4.1) combined with HL7 (Health Level Seven International) Fast Healthcare Interoperability Resources (FHIR) Standard:

   • Description: An intraoral device, similar to US11589970, augmented with embedded pH and temperature sensors within its main body (e.g., at the posterior wall near the bridge structure and at the suction inlet). The data collected from these sensors is digitally transmitted (e.g., via Bluetooth LE or NFC) to a local gateway. This gateway then formats the sensor data according to the HL7 FHIR standard for real-time integration into the patient's Electronic Health Record (EHR) system. This allows for automated, hands-free monitoring of oral cavity conditions during prolonged dental procedures, enhancing diagnostic and treatment protocols. The FHIR resources for "Observation" or "DeviceMetric" would be utilized to store and exchange the pH and temperature readings, along with timestamps and device identifiers.

2. Modular Mouthpiece System with Standardized Attachment Interfaces and STEP (ISO 10303) Format for CAD Models:

   • Description: The intraoral device of US11589970, particularly its modularity allowing for different sized mouth props, can be extended to a system where the main body, suction connector, and mouth prop are separate, interchangeable components with standardized mechanical interfaces (e.g., a universal dovetail or bayonet coupling for the mouth prop, and a conical luer lock for the suction line attachment). The CAD models for these standardized interfaces, along with various sizes and configurations of each component (e.g., pediatric, adult small, medium, large mouth props; different cheek retractor shapes), are made publicly available in the ISO 10303 (STEP) file format. This enables third-party manufacturers and dental labs to design and produce compatible, customized, or specialized accessories that can be seamlessly integrated with the core mouthpiece components, fostering an open ecosystem for dental isolation devices.

3. Autoclavable Mouthpiece (as per US11589970, general) manufactured under an ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes) Certified Process:

   • Description: The manufacturing process for the reusable, autoclavable silicone-based intraoral device (main body, bridge, suction connector, mouth prop) described in US11589970 is executed under a Quality Management System that is certified to ISO 13485 standards. This includes adherence to documented procedures for material selection (e.g., medical-grade silicone), injection molding, quality control inspections (e.g., dimensional accuracy, absence of defects, integrity of perforations and bridge structure), traceability of raw materials and finished products, and validation of the sterilization process (e.g., resistance to steam sterilization at 134°C for 18 minutes, as per ISO 17665). This combination makes explicit the integration of a well-known industry standard for medical device quality management with the invention, asserting the obvious need for such robust quality controls in manufacturing for any reusable medical device of this nature.