IP Verse

Venous Access Port Assembly With X-Ray Discernable Indicia

Patent No. US11878137 (titled "Venous Access Port Assembly With X-Ray Discernable Indicia") was filed by Medical Components Inc on Dec 15, 2020.

What is this patent about?

’137 is related to the field of implantable medical devices , specifically venous access ports. These ports are implanted beneath the skin and connected to a catheter, allowing repeated access to a patient's veins for drug infusion or blood withdrawal. A key challenge is identifying the specific characteristics of an implanted port non-invasively after implantation.

The underlying idea behind ’137 is to incorporate radiopaque indicia into the venous access port housing. These indicia, visible via X-ray, communicate a key attribute of the port, such as its suitability for power injection of contrast fluids during CT scans. This allows medical personnel to quickly and easily determine the port's capabilities without needing to consult patient records or perform invasive procedures.

The claims of ’137 focus on an implantable venous access port assembly comprising a needle-penetrable septum and a housing. The housing includes a radiopaque material with at least one cutout forming an X-ray discernable indicium . This indicium indicates an attribute of the access port assembly. Another claim focuses on the indicia being visible in mirror-image orientation from the bottom of the port assembly.

In practice, the radiopaque indicia can be implemented in several ways. One approach involves using a disc of radiopaque material, such as titanium, with cutouts in the shape of letters (e.g., "CT" for contrast tomography). This disc can be affixed to the bottom of the housing or embedded within the housing material. Alternatively, the indicia can be formed from discrete elements of radiopaque material arranged to form the desired symbol or letters.

The differentiation from prior approaches lies in the direct and unambiguous visual communication of the port's attribute via X-ray. Previous venous access ports lacked such integrated identification features, requiring reliance on external markings, patient records, or potentially risky procedures to determine the port's capabilities. The '137 invention provides a simple and reliable method for identifying key port characteristics, improving patient safety and streamlining medical procedures.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2000s when ’137 was filed, medical devices such as venous access ports were typically implemented using materials and designs that balanced biocompatibility with the need for radiographic visibility. At a time when X-ray imaging was a standard diagnostic tool, ensuring that implanted devices could be easily located and identified using radiopaque markers was a common engineering constraint. When hardware or software constraints made precise, real-time imaging non-trivial, incorporating physical markers directly into the device was a widely adopted practice.

Novelty and Inventive Step

The claims in this application were rejected. The examiner issued rejections based on anticipation under pre-AIA 35 U.S.C. 102(e) and obviousness under pre-AIA 35 U.S.C. 103(a) over prior art. Additionally, claims were rejected for nonstatutory double patenting over several earlier patents. The prosecution record does not describe the technical reasoning or specific claim changes that led to allowance.

Claims

This patent includes 30 claims, with independent claims 1 and 15 directed to implantable venous access port assemblies having a needle-penetrable septum and a housing with X-ray discernable indicia. The dependent claims elaborate on the composition, attributes, and configuration of the radiopaque material and X-ray discernable indicia within the port assembly.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Attribute of the access port assembly
(Claim 1)		“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. The attribute in this example is the property of the port being adapted to withstand high pressures that are used for injection of contrast fluid into a patient, and the letters “CT” would be understood in medical practice to indicate that the port is suitable for the high pressure injection of contrast fluid.”A characteristic or property of the venous access port assembly, such as its suitability for power injection.
Mirror-image orientation
(Claim 15)		“With either embodiment, the disc or letters may be insert molded within the housing base bottom wall, or they may be affixed to the bottom surface of the housing base, preferably within complementary recesses thereinto, in such a manner that the letters “CT” are readable from above the port assembly in an X-ray.”The indicia is formed such that it is a mirror image when viewed from the bottom of the port assembly.
Needle-penetrable septum
(Claim 1, Claim 15)		“Venous access ports for the infusion and/or withdrawal of fluids from a patient are well-known, secured to the proximal end of an implanted catheter. These ports are typically used for drug infusion or for withdrawal of small amounts of blood, where large flows of 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 the 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 that can be repeatedly pierced by a needle to access the reservoir within the venous access port.
Radiopaque material
(Claim 1)		“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.”A material that is opaque to X-rays, allowing it to be visible in an X-ray image.
X-ray discernable indicium
(Claim 1, Claim 15)		“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.”A mark or symbol that can be distinguished or recognized in an X-ray image.

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US11878137

MEDICAL COMPONENTS INC
Application Number
US17122251
Filing Date
Dec 15, 2020
Status
Granted
Expiry Date
Mar 23, 2028
External Links
Slate, USPTO, Google Patents