IP Verse

Venous Access Port Assembly With X-Ray Discernable Indicia

Patent No. US10874842 (titled "Venous Access Port Assembly With X-Ray Discernable Indicia") was filed by Medical Components Inc on Aug 30, 2016.

What is this patent about?

’842 is related to the field of medical devices, specifically implantable venous access ports. These ports are used for delivering fluids to or withdrawing fluids from a patient, typically for drug infusion or blood sampling. The background involves the need for repeated access without constantly searching for new entry points, which is addressed by a self-sealing septum within a housing connected to a catheter.

The underlying idea behind ’842 is to incorporate X-ray-discernible markings on a venous access port to indicate a specific attribute of the port after implantation. This allows medical personnel to quickly identify the port's capabilities, such as its suitability for power injection during CT scans, without needing to consult patient records or perform invasive procedures.

The claims of ’842 focus on an implantable venous access port assembly featuring a needle-penetrable septum and a housing. Crucially, the housing includes X-ray discernable indicia , such as cutouts through radiopaque material, that identify a specific attribute of the port. Some claims specify that these indicia are visible in a mirror-image orientation from the top or bottom of the assembly.

In practice, the invention involves embedding or affixing radiopaque elements, like a titanium disc with 'CT' cutouts, to the port's housing. This can be achieved by insert molding the disc within the housing's bottom wall or attaching it to the outer surface. A silicone skirt is then molded over the housing, allowing the indicia to be visible under X-ray while also providing a biocompatible exterior.

The differentiation from prior approaches lies in the ability to non-invasively determine port attributes post-implantation. Instead of relying on records or potentially risky procedures to identify a port's capabilities, the X-ray-discernible indicia provide a clear visual indicator. The mirror-image orientation ensures the indicia appear correctly on the X-ray image, regardless of the port's orientation within the patient.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2000s when ’842 was filed, venous access ports were well-established medical devices, at a time when such ports typically relied on a needle-impenetrable housing, a self-sealing septum, and a discharge port in fluid communication with a catheter. At this time, incorporating features detectable via X-ray was a known method for identifying implanted devices, when hardware or software constraints made precise localization or identification non-trivial.

Novelty and Inventive Step

The application was rejected multiple times. Claims were rejected under pre-AIA 35 U.S.C. 102(b) and 102(e) as being anticipated by prior art. Claims were also rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over prior art combinations. Additionally, claims were rejected on the ground of nonstatutory double patenting. The prosecution record does NOT describe the technical reasoning or specific claim changes that led to allowance.

Claims

This patent contains 37 claims, with independent claims 1, 13, and 25 directed to implantable venous access port assemblies having a needle-penetrable septum, a housing, and X-ray discernable indicia. The dependent claims generally elaborate on specific materials, configurations, and attributes of the X-ray discernable indicia and housing.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Cut outs formed
(Claim 1, Claim 25)		“One such key attribute in particular would be for example that the venous access port is rated to be used for power injection such as of contrast fluid, wherein for example the letters “CT” (for “computed tomography”, or “contrast enhanced computed tomography”) would be provided that are of radiopaque material, or are cutouts through radiopaque material. In one embodiment, a disc of radiopaque material includes cutouts of letters “CT” (although other indicia may be utilized) through the body of the disc.”Shapes or symbols created by removing material from a radiopaque portion of the port assembly, allowing X-rays to pass through and create a visible pattern.
Identify an attribute
(Claim 1, Claim 25)		“An embodiment of the present invention includes the incorporation of X-ray discernable indicia onto a venous access port that is discernible under X-ray examination to provide information concerning the nature or key attribute of the venous access port, so that the practitioner, subsequent to the date of implantation thereof, can determine that nature or key attribute under X-ray examination. One such key attribute in particular would be for example that the venous access port is rated to be used for power injection such as of contrast fluid, wherein for example the letters “CT” (for “computed tomography”, or “contrast enhanced computed tomography”) would be provided that are of radiopaque material, or are cutouts through radiopaque material.”To indicate a specific characteristic or property of the access port assembly, such as its suitability for power injection.
Needle-penetrable septum
(Claim 1, Claim 13, Claim 25)		“These ports are typically used for drug infusion or for withdrawal of small amounts of blood, where large flows at fluid are not required. The ports are assemblies of a needle-impenetrable housing with a discharge port in fluid communication with a catheter and a reservoir within t e port housing, and provide a subcutaneous self-sealing septum that defines an access site for multiple needle sticks through the covering skin tissue of the patient, through the septum, and into the reservoir, without the need to continuously search for new access sites.”A self-sealing barrier within the venous access port housing that can be repeatedly pierced by a needle to access the reservoir inside the port.
Radiopaque material
(Claim 1, Claim 25)		“One such key attribute in particular would be for example that the venous access port is rated to be used for power injection such as of contrast fluid, wherein for example the letters “CT” (for “computed tomography”, or “contrast enhanced computed tomography”) would be provided that are of radiopaque material, or are cutouts through radiopaque material. In one embodiment, a disc of radiopaque material includes cutouts of letters “CT” (although other indicia may be utilized) through the body of the disc.”A substance that is opaque to X-rays, used in the housing or indicia of the venous access port to make it visible under X-ray examination.
X-ray discernable indicia
(Claim 1, Claim 13, Claim 25)		“An embodiment of the present invention includes the incorporation of X-ray discernable indicia onto a venous access port that is discernible under X-ray examination to provide information concerning the nature or key attribute of the venous access port, so that the practitioner, subsequent to the date of implantation thereof, can determine that nature or key attribute under X-ray examination. One such key attribute in particular would be for example that the venous access port is rated to be used for power injection such as of contrast fluid, wherein for example the letters “CT” (for “computed tomography”, or “contrast enhanced computed tomography”) would be provided that are of radiopaque material, or are cutouts through radiopaque material.”Markings or symbols on the venous access port assembly that are visible under X-ray examination and provide information about a characteristic or property of the port.

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US10874842

MEDICAL COMPONENTS INC
Application Number
US15251122
Filing Date
Aug 30, 2016
Status
Granted
Expiry Date
Nov 16, 2029
External Links
Slate, USPTO, Google Patents