“Tamper Resistant Devices” in Patent Application Approval Process (USPTO 20230127148): Patent Application

2023 MAY 16 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- A patent application by the inventors Searcy, Marya L. (Tampa, Fl, Us); Williams, Kevin B. (Clearwater, Fl, Us), filed on October 12, 2022, was made available online on April 27, 2023, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application has not been assigned to a company or institution.

The following quote was obtained by the news editors from the background information supplied by the inventors: “There are numerous circumstances in which a patient may require the placement of an intravenous (IV) catheter. A few examples include: the administration of IV fluids for hydration, electrolyte replacement, antibiotic therapy, administration of injectable narcotics (i.e., patient-controlled analgesia/PCA), blood administration and/or sampling (physician ordered lab work), and dialysis therapies. Patients may have these central or peripherally placed IV catheters in place for varying lengths of time; from a few hours to several months. One imperative is that the IV catheters and medical fluid lines access ports (aka Leurs, Claves) are only accessed by trained medical professionals after being appropriately disinfected to prevent the introduction of bacterial agents into the patient’s bloodstream.

“The prevention and detection of patient tampering with these injectable access ports is critically important in both the inpatient and outpatient settings. Patients with IV catheters possess a multitude of physical and mental conditions that can contribute to an individual’s intent to either intentionally or unintentionally tamper with their IV catheter or access ports by disconnecting prescribed medical treatments or by self-injecting substances not medically prescribed into them. All these actions lead to increased hospital lengths of stay for inpatients, extended outpatient treatments, delayed healing, potential for infection, potential transmission of blood borne pathogens, prolongation of opiate abuse/addiction, potential overdose and death.

“Hospitals have a duty to protect patients from harm. Currently, there are no effective safety devices that exist to prevent patients from accessing and tampering with indwelling IV catheter access ports and/or the access ports on any medical fluid lines. The Centers for Medicare and Medicaid Services (CMS) have identified 8 high-cost, high-frequency events they do not reimburse for and consider “never-events”. One of these never-events is hospital acquired bloodstream infections. No effective devices exist which are capable of ensuring that IV catheters and medical fluid line access ports are only accessed by trained medical professionals and of reducing the risks associated with a blood stream infection.

“Consequently, there is a need for a tamper resistant device that is effective for the prevention and detection of tampering with medical fluid lines access ports by unauthorized persons.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors’ summary information for this patent application: “The present invention is directed in the creation of tamper resistant devices that can effectively discourage and/or prevent both hospitalized and home health patients from tampering with access to in-situ intravenous (IV) medical catheter devices (placed either centrally or peripherally) and their corresponding medical fluid lines with access ports. The tamper resistance devices of the present invention are particularly effective to prevent disconnection of such medical fluid lines and to provide evidence of either tampering or disconnection.

“The devices of the present invention are aimed at ensuring that IV catheters and medical fluid line access ports are only accessed by trained medical professionals and at reducing the risks associated with a blood stream infection.

“In a first embodiment, the tamper resistant device comprises first and second shell members each having an interior space and connecting means for removably connecting the first and second shell members together. The second shell member has an outer diameter portion smaller than an inner diameter of the first shell member so that in a connected state, the second shell member is received by the interior space of the first shell member and an inner circumferential surface portion of the first shell member encircles and covers an outer circumferential surface portion of the second shell member. In the connected state, the first and second shell members together form an interior space for holding a portion of an access port of a fluid line to prevent tampering with the access port by unauthorized persons.

“As an exemplary feature of the first embodiment, the means for removably connecting the first and second shell members together comprises at least one locking element formed in the interior space of the first shell member and at least one locking hole formed in the second shell member for removably receiving the at least one locking element.

“As other exemplary features of the first embodiment, each of the first shell member and the second shell member has a unitary structure made of a single piece of material, and/or made of a flexible material, and/or having a generally semi-circular cross-section.

“As yet another exemplary feature, the tamper resistant device of the first embodiment further comprises tamper detection means for providing a visual indication of tampering with the first and/or second shell members. As an example, the tamper detection means comprises one of a tamper detection sticker and a tamper evident shrink band or wrap applied to a preselected region of the first and/or second shell members.

“In a second embodiment, the tamper resistant device comprises a shell member having a unitary structure made of a single piece of material, the shell member having a first tubular portion with a first interior space and a second tubular portion with a second interior space and extending from the first tubular portion, the first and second interior spaces being configured to receive and retain therein an access port of a fluid line to prevent tampering with the access port by unauthorized persons. The tamper resistant device of the second embodiment further comprises means for removably holding and retaining the access port within the first and second interior spaces of the first and second tubular portions of the shell member.

“As one exemplary feature of the second embodiment, the means for removably holding and retaining the access port comprises a locking element separate from the shell member and a through-hole formed in the first tubular portion of the shell member for removably receiving the locking element so as to engage the access port retained in the first interior space of the first tubular portion.

“As another exemplary feature of the second embodiment, the tamper resistant device further comprises a tool member for removing the locking element from the through-hole of the first tubular portion to permit removal of the access port from the first and second tubular portions.

“As yet another exemplary feature, the tamper resistant device of the second embodiment further comprises tamper detection means for providing a visual indication of tampering with the shell member. As an example, the tamper detection means comprises one of a tamper detection sticker and a tamper evident shrink band or wrap applied to a preselected region of the shell member.

“In a third embodiment, the tamper resistant device comprises a cap member having an open end providing access into an interior space of the cap member configured to receive and removably retain therein an open port of a fluid line, and means for removably holding and retaining the open port within the interior space of the cap member to prevent unauthorized tampering with the open port by unauthorized persons.

“As one exemplary feature of the third embodiment, the means for removably holding and retaining the open port comprises a locking element and a through-hole formed in the cap member for removably receiving the locking element so that the locking element engages and retains the access port within the interior space of the cap member.

“As another exemplary feature of the third embodiment, the tamper resistant device further comprises a disinfecting element disposed within the interior space of the cap member for contacting and maintaining in a disinfected state the access port disposed in the interior space.

“As yet another exemplary feature of the third embodiment, the tamper resistant device further comprises detection means for providing a visual indication of tampering with the cap member. As an example, the tamper detection means comprises one of a tamper detection sticker and a tamper evident shrink band or wrap applied to a preselected region of the cap member.

“These and other features and advantages of the present invention will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings.”

The claims supplied by the inventors are:

“1. A tamper resistant device for holding a portion of an access port of a fluid line, the tamper resistant device comprising: a first shell member having an interior space; a second shell member having an interior space and configured to be removably connected to the first shell member, the second shell member having an outer diameter portions smaller than an inner diameter of the first shell member so that in a connected state, the second shell member is received by the interior space of the first shell member and an inner circumferential surface portion of the first shell member encircles and covers an outer circumferential surface portion of the second shell member, and in the connected state the first and second shell members together form an interior space for holding a portion of an access port of a fluid line to prevent tampering with the access port by unauthorized persons; and means for removably connecting the first and second shell members together.

“2. The tamper resistant device of claim 1, wherein the means for removably connecting the first and second shell members together comprises at least one locking element formed in the interior space of the first shell member and at least one locking hole formed in the second shell member for removably receiving the at least one locking element.

“3. The tamper resistant device of claim 2, wherein the at least one locking element comprises a plurality of locking elements, and the at least one locking hole comprises a plurality of locking holes for removably receiving the respective plurality of locking element.

“4. The tamper resistant device of claim 1, wherein the first and second shell members are made of a flexible material.

“5. The tamper resistant device of claim 1, wherein each of the first shell member and the second shell member has a unitary structure made of a single piece of flexible material.

“6. The tamper resistant device of claim 1, wherein each of the first shell member and the second shell member has a generally semi-circular cross-section.

“7. The tamper resistant device of claim 1, further comprising tamper detection means for providing a visual indication of tampering with the first and/or second shell members.

“8. The tamper resistant device of claim 7, wherein the tamper detection means comprises one of a tamper detection sticker and tamper evident shrink band or wrap applied to a preselected region of the first and/or second shell members.

“9. A tamper resistant device for holding a portion of an access port of a fluid line, the tamper resistant device comprising: a shell member having a unitary structure made of a single piece of material, the shell member having a first tubular portion having a first interior space and a second tubular portion extending from the first tubular portion and having a second interior space, the first and second interior spaces being configured to receive and retain therein an access port of a fluid line to prevent tampering with the access port by unauthorized persons; and means for removably holding and retaining the access port within the first and second interior spaces of the first and second tubular portions of the shell member.

“10. The tamper resistant device of claim 9, wherein the means for removably holding and retaining the access port comprises a locking element separate from the shell member and a through-hole formed in the first tubular portion of the shell member for removably receiving the locking element so as to engage the access port retained in the first interior space of the first tubular portion.

“11. The tamper resistant device of claim 10, further comprising a tool member for removing the locking element from the through-hole of the first tubular portion to permit removal of the access port from the first and second tubular portions.

“12. The tamper resistant device of claim 9, wherein the second tubular portion has an outer diameter smaller than an outer diameter of the first tubular portion.

“13. The tamper resistant device of claim 9, further comprising tamper detection means for providing a visual indication of tampering with the shell member.

“14. The tamper resistant device of claim 13, wherein the tamper detection means comprises one of a tamper detection sticker and tamper evident shrink band or wrap applied to a preselected region of the shell member.

“15. A tamper resistant device for closing an open port of a fluid line, the tamper resistant device comprising: a cap member having an open end providing access into an interior space of the cap member configured to receive and removably retain therein an open port of a fluid line; and means for removably holding and retaining the open port within the interior space of the cap member to prevent unauthorized tampering with the open port by unauthorized persons.

“16. The tamper resistant device of claim 15, wherein the means for removably holding and retaining the open port comprises a locking element separate from the cap member and a through-hole formed in the cap member for removably receiving the locking element so as to engage and retain the access port within the interior space of the cap member.

“17. The tamper resistant device of claim 15, further comprising a disinfectant element disposed within the interior space of the cap member for contacting and maintaining in a disinfected state the access port disposed in the interior space.

“18. The tamper resistant device of claim 15, further comprising tamper detection means for providing a visual indication of tampering with the cap member.

“19. The tamper resistant device of claim 18, wherein the tamper detection means comprises one of a tamper detection sticker and tamper evident shrink band or wrap applied to a preselected region of the cap member.

“20. The tamper resistant device of claim 15, wherein the cap member has a closed end opposite the open end.”

URL and more information on this patent application, see: Searcy, Marya L.; Williams, Kevin B. Tamper Resistant Devices. U.S. Patent Application Number 20230127148, filed October 12, 2022 and posted April 27, 2023. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20230127148)&db=US-PGPUB&type=ids

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