WO2023212125A1 - Venous access systems and methods of using thereof - Google Patents
Venous access systems and methods of using thereof Download PDFInfo
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- WO2023212125A1 WO2023212125A1 PCT/US2023/020082 US2023020082W WO2023212125A1 WO 2023212125 A1 WO2023212125 A1 WO 2023212125A1 US 2023020082 W US2023020082 W US 2023020082W WO 2023212125 A1 WO2023212125 A1 WO 2023212125A1
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- needle
- port
- patient
- housing
- catheter
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
- A61M2039/0238—Subcutaneous access sites for injecting or removing fluids having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/60—General characteristics of the apparatus with identification means
- A61M2205/6054—Magnetic identification systems
Definitions
- Implantable access ports such as central venous access ports provide a convenient method to repeatedly deliver a substance to remote areas of the body by way of an attached catheter without utilizing a surgical procedure each time. Ports are implantable within the body and permit the infusion of medicine, parenteral solutions, blood products, or other fluids. Additionally, ports are also used for blood sampling.
- a port is subcutaneously implanted within the body, and a catheter is connected to the port in fluid communication therewith.
- the catheter is routed to a remote area where a fluid is desired to be delivered or removed.
- a caregiver locates a septum of the port by palpation of a patient’s skin.
- Port access is accomplished by percutaneously inserting a needle, typically a non-coring needle, through the septum of the port and into a chamber of the port.
- a fluid containing a drug or some other beneficial substance can then be administered by bolus injection or continuous infusion into the chamber of the port.
- the fluid then flows through the chamber into the catheter and finally to the remote site where the fluid is desired.
- venous access systems can comprise an implantable port and a port access device.
- the implantable port and the port access device can include wireless communication components (e.g., components facilitating near-field communication (NFC) between the implantable port and the port access device) which permit proper placement of the port access device relative to the injection port to ensure proper percutaneous access to the port. This can eliminate complications, improve sterility, and/or reduce patient discomfort.
- wireless communication components e.g., components facilitating near-field communication (NFC) between the implantable port and the port access device
- NFC near-field communication
- the implantable port can comprise a biocompatible housing having a fluid reservoir disposed therewithin; a needle-penetrable septum disposed atop the fluid reservoir; a catheter connector in fluid communication with the fluid reservoir, the catheter connector configured to be mated to a first catheter; and a wireless tag configured to transmit data to an external tag reader.
- the wireless tag can comprise one or more passive radio- frequency identification (RFID) tags (e.g., one or more passive near-field communication (NFC) tags).
- RFID passive radio- frequency identification
- NFC passive near-field communication
- the wireless tag(s) can be positioned within biocompatible housing of the implantable port, such as beneath the fluid reservoir.
- the port access device can comprise a housing having a patient-contacting surface; an injector disposed within the housing, the injector comprising an actuatable needle having an internal lumen that is fluidly connected to a second catheter; a tag reader and processor configured to communicate with the wireless tag and provide a signal to a user via a position indicator when the port access device is positioned proximally to the implantable port at an injection position such that actuation of the needle will advance the needle from the housing through the needle-penetrable septum; and a power supply operatively coupled to the tag reader and processor.
- the position indicator can comprise one or more LEDs which indicate to a user when the port access device is positioned in the injection position.
- the housing further comprises a conduit through which the second catheter passes.
- the device further comprises an injection trigger that effectuates actuation of the needle.
- the patient-contacting surface further comprises an occlusive dressing.
- the occlusive dressing comprises a multilayer occlusive dressing comprising a disinfecting layer.
- the actuatable needle comprises a Huber needle (a non-coring needle), a Trocar needle, or a pencil point needle.
- the actuatable needle comprises a Huber needle.
- the housing comprises a top segment detachably coupled to a base. In certain embodiments, the top segment can slidably connect to the base.
- the top segment and the base can be joined using a tongue and groove joint.
- the top segment can include one or more tongues extending from the top segment that are slidably received into and intimately interlock with one or more grooves formed within the base.
- the power supply can be disposed within the top segment, and the one or more tongues can further comprise electrical contacts that are electrically coupled to the power supply.
- the base can include one or more tongues extending from the base that are slidably received into and intimately interlock with one or more grooves formed within the top segment.
- the power supply is disposed within the top segment, and the one or more grooves further comprise electrical contacts that are electrically coupled to the power supply.
- the system can further comprise a recharging station for the power supply.
- the top segment can be couplable to the recharging station, and coupling of the top segment to the recharging station can allow for recharging the power supply. In some cases, this can comprise wireless charging. In other embodiments, recharging can occur via electrical contacts incorporated in the top segment (e.g., electrical contacts present in the one or more tongues extending from the top segment or the one or more grooves formed within the top segment).
- the power supply, the tag reader, and the position indicator are all disposed within the top segment.
- the injector (e.g., including the actuatable needle and at least a portion of the second catheter), is disposed within the base.
- the base can disposable.
- the top segment is reusable.
- the base is a single use device provided within sterile packaging. Also provided herein are methods for introducing a needle into an implanted port in a patient. These methods can comprise providing a patient having an implanted port described herein; positioning the patient-contacting surface of a port access device described herein against the patient at the injected position; and actuating the needle of the port access device to advance the needle from the housing into the patient and through the needle-penetrable septum.
- the positioning step can comprise positioning the patient- contacting surface of the port access device against the patient in a region where the implantable port is located; and translocating the port access device across the patient until the position indicator indicates that the port access device is located at the injection position.
- TIVAP totally implantable venous access port
- Figure 2 depicts a perspective view of an example implantable port described herein.
- Figure 3 depicts an exploded perspective view of an example implantable port described herein.
- Figure 4 depicts a perspective view of an example port access device described herein.
- FIG. 5 depicts a perspective view of an example port access device described herein with the top segment and base portions decoupled.
- Figure 6 depicts a perspective view of an example port access device described herein.
- Figure 7 depicts a cross-sectional side view of an example port access device described herein.
- DETAILED DESCRIPTION Provided herein are venous access systems. These venous access systems can comprise an implantable port and a port access device.
- the implantable port and the port access device can include wireless communication components (e.g., components facilitating near-field communication (NFC) between the implantable port and the port access device) which permit proper placement of the port access device relative to the injection port to ensure proper percutaneous access to the port.
- NFC near-field communication
- Implanted ports also referred to as totally implantable venous access ports (TIVAPs)
- TIVAPs totally implantable venous access ports
- the port itself is an imaging-compatible medical device that rests beneath the skin and connects to a catheter that runs into a nearby blood vessel.
- the most common and stable location for an implanted port is the right chest but they can also be found on the arm, underarm, and left chest.
- FIG. 1 shows the typical form and design of an implantable port as well as the standard, manual method for accessing the port.
- a health care provider can typically access the implanted port percutaneously with a needle that has an attached cannula, from which the liquid medium can be delivered.
- Successfully accessing an implantable port relies on many factors, including the clinician’s skill or experience, the port’s depth below the surface of the skin, the port’s orientation (such as being askew or flipped over), and the tissue type, such as extensive breast or scar tissue interference. Infections outside accessing the port is uncommon; therefore, this process plays an important role in minimizing complications due to blood- stream infections since strict adherence to procedural standards is the best mode of prevention and helps avoid the increased morbidity, mortality, costs, and hospitalization that accompany infection.
- the process of accessing the port is a sterile procedure so there are typically several steps and various items included in a port accessing kit.
- the current port access kits come with numerous supplies which makes it easy for a nurse or clinician to intentionally or unintentionally alter or skip a step. Further, complications can arise that may inhibit a clinician from successfully accessing a patient’s implanted port.
- Many ports feature three prongs on the surface of the septum. These prongs create a visible, outward impression on the skin and act as guide points for access, however, some ports are not equipped with this feature. In rare cases, the port may flip over or turn sideways, completely undermining the purpose of the prongs.
- the venous access systems described herein can automate the process of accessing an implanted port, increasing the convenience of the procedure for clinicians and patients, decrease the rate at which patients’ ports are unsuccessfully accessed, decreasing patient discomfort, minimizing complications, eliminating unnecessary contact with the implantation site, improving the probability that the injection site remains sterile, and/or decreasing the rate of infections.
- the venous access systems can comprise an implantable port and a port access device.
- FIGS. 2 and 3 illustrate an example implantable port.
- Figure 2 depicts a perspective view of an example implantable port described herein while Figure 3 depicts an exploded perspective view of an example implantable port described herein.
- the implantable port 108 can include a biocompatible housing 102 having a fluid reservoir 118 disposed therewithin; a needle-penetrable septum 116 disposed atop the fluid reservoir; a catheter connector 128 in fluid communication with the fluid reservoir, the catheter connector configured to be mated to a first catheter 110; and a wireless tag 140 configured to transmit data to an external tag reader.
- the biocompatible housing 102 can comprise a generally dome-shaped upper housing 112 and a disk-shaped lower housing 114.
- Upper and lower housings 112, 114 can be constructed of a body-tolerant material such as titanium or a body-compatible plastic, and sealed to one another about their periphery.
- the upper housing 112 can define an access port 115 to provide access to a centrally-located needle- penetrable septum 116.
- the septum 116 can define an upper boundary of a fluid reservoir 118.
- a chamber wall 120 which in some embodiments is substantially cylindrical in shape, can define the walls 120 of the fluid reservoir 118.
- the chamber wall 120 can be made of a rigid material, such as a biocompatible polymer or titanium.
- the septum 116 can be constructed of a resilient, pliable material such as a self-sealing silicone rubber.
- a fill port washer 124 can be positioned between the septum 116 and the chamber wall 120.
- an optional needle screen (not depicted) positioned adjacent to the septum 116 can inhibit needles having a diameter larger than a given diameter from passing therethrough while allowing needles having diameters that are smaller than the given diameter to pass therethrough.
- a needle stop can rest on the lower housing 114.
- an implantable catheter 110 can be connected to the implantable port 108 by sliding a proximal end 126 of the catheter 110 over a catheter connector 128 of the implantable port 108.
- the catheter connector 128 can be operably coupled to the upper and lower housings 112, 114, for example via an O-ring.
- the catheter connector 128 can be in fluid communication with the fluid reservoir 118 via conduit 132.
- a quantity of medicament injected percutaneously into the fluid reservoir of implantable port 108 can pass from the fluid reservoir to a distal end 134 of the catheter 110.
- a needle filled with the medicament can be passed through a patient's skin, through the access port 115 and into the septum 116 to enter into the fluid reservoir 118.
- the medicament fills the fluid reservoir 118, passes through the conduit 132 and into a lumen of the catheter 110 generally extending between the proximal end 126 and an infusion port 136 in proximity to the distal end 134.
- the infusion port 136 can be positioned on the distal end or tip 134 of the catheter 110. Alternatively, as depicted, the infusion port 136 can be positioned proximately from the distal tip 134 along the body of the catheter 110.
- the fluid reservoir 118 of the implantable port 108 can be impregnated or pre-loaded with one or more dosages of medicament. Thereafter, a healthcare provider can dispense one of the doses by applying pressure to the septum 116 or other movable portion of the port 108 to force the dose through the conduit 132 and into the catheter 110. If more than one dose is provided, the dosages can be separated by movable doors (not depicted) extending across the fluid reservoir 118.
- the doors can be constructed of a ferritic material and be selectively and non-invasively moved by a clinician using an external device having one or more magnets therein.
- the distal tip 134 of the catheter 104 can be positioned at a desired site within the patient for administration of medicament, for example within the intrathecal space of the patient, among other desirable targeted drug delivery sites.
- the catheter 110 can provide a substantially homogeneous delivery of medicament to the intrathecal space or other desirable targeted drug delivery site of a patient.
- the catheter 110 can be configured to extend along substantially the entire length of a patient's spinal column or along any portion thereof.
- the catheter 110 can be configured for long term implantation into a patient and, as such, can be constructed from materials to make the catheter soft, flexible, and kink resistant. Further, in some embodiments, the catheter 110 can be configured to accommodate complex spine patients (e.g., scoliosis), the materials can provide column strength, break resistance, and stiffness so that the catheter 110 can be threadable during insertion. In some examples, the catheter 110 can be provided with an extended length so that a healthcare provider can cut the catheter 110 to a desired length for a particular patient.
- complex spine patients e.g., scoliosis
- the materials can provide column strength, break resistance, and stiffness so that the catheter 110 can be threadable during insertion.
- the catheter 110 can be provided with an extended length so that a healthcare provider can cut the catheter 110 to a desired length for a particular patient.
- the catheter 110 can include one or more radiopaque markings (not depicted) or components to be visible under imaging.
- the wireless tag(s) can be positioned within biocompatible housing of the implantable port, such as beneath the fluid reservoir.
- the wireless tag(s) can be centrally positioned within biocompatible housing of the implantable port, such as centrally beneath the fluid reservoir.
- the wireless tag(s) are enclosed or encapsulated within the housing, such that they are not in contact with biological fluids. According to preferred embodiments, the wireless tag(s) are capable of remote activation.
- the wireless tag can comprise one or more radio-frequency identification (RFID) tags.
- the wireless tag can comprise one or more near-field communication (NFC) tags.
- the port can comprise a single radio-frequency identification (RFID) tag (e.g., a single NFC tag).
- the port can comprise a plurality of radio-frequency identification (RFID) tags (e.g., a plurality of NFC tags).
- the port can comprise an array of radio-frequency identification (RFID) tags (e.g., an array of NFC tags), for example, circumferentially disposed about the housing.
- the RFID tags and NFC tags can be either "passive" tags that require remote activation and power, or "active" tags.
- the port access device 200 can comprise a housing 201 having a patient-contacting surface 228.
- the overall shape of the housing can vary and be selected, for example, to facilitate clinical use and improve patient comfort and compliance.
- the patient-contacting surface can comprise a cushioned or form-factored surface to improve adherence to the patient and increase comfort during use.
- An injector 230 is disposed within the housing.
- the injector can comprise an actuatable needle 218 having an internal lumen that is fluidly connected to a second catheter 220.
- the injector can comprise a simple mechanical or electromechanical mechanism (e.g., an angled tooth cam mechanism, such as that utilized in retractable pens; see U.S. Patent No. 3,205,863) that provides for advancement of the needle out of the housing (in the general direction indicated by the arrow in Figure 7).
- the actuatable needle can comprise, for example, a Huber needle (a non-coring needle), a Trocar needle, or a pencil point needle.
- the actuatable needle comprises a Huber needle.
- the housing can further comprise a conduit 210 through which the second catheter 220 passes.
- the device further comprises an injection trigger 212 (e.g., a button) that effectuates actuation of the needle.
- the device can further comprise a tag reader and processor 222 configured to communicate with the wireless tag and provide a signal to a user via a position indicator 208 when the port access device is positioned proximally to the implantable port at an injection position such that actuation of the needle will advance the needle from the housing through the needle-penetrable septum.
- the position indicator 208 can comprise one or more LEDs which indicate to a user when the port access device is positioned in the injection position.
- the position indicator can comprise one or more LEDs which illuminate when the port access device is positioned in the injection position.
- the position indicator can comprise one or more LEDs which change color (e.g., from red to green) when the port access device is positioned in or reaches the injection position.
- the device can further comprise a power supply 224 operatively coupled to the tag reader and processor 222.
- the power supply 224 can further be operatively coupled to the position indicator 208.
- the patient-contacting surface further comprises an occlusive dressing.
- the occlusive dressing comprises a multilayer occlusive dressing comprising a disinfecting layer (e.g., ChloraPrep).
- the housing 201 can comprise a top segment 202 detachably coupled to a base 204.
- the top segment 202 can slidably connect to the base 204.
- the top segment 202 and the base 204 can be joined using a tongue and groove joint or sliding dovetail joint.
- the top segment 202 can include one or more tongues 206 extending from the top segment that are slidably received into and intimately interlock with one or more grooves 214 formed within the base 204.
- the base can include one or more tongues extending from the base that are slidably received into and intimately interlock with one or more grooves formed within the top segment.
- the tongues can be dovetailed, so prevent the top segment and the base from separating or lifting away from the base when the device is lifted by the top segment.
- the power supply 224 can be disposed within the top segment 202, and the one or more tongues 206 can further comprise electrical contacts 216 that are electrically coupled to the power supply.
- the power supply 224 can be disposed within the top segment 202, and the one or more grooves can further comprise electrical contacts that are electrically coupled to the power supply.
- the system can further comprise a recharging station (not shown) for the power supply.
- the top segment can be couplable to the recharging station, and coupling of the top segment to the recharging station can allow for recharging the power supply. In some cases, this can comprise wireless charging. In other embodiments, recharging can occur via electrical contacts incorporated in the top segment (e.g., electrical contacts present in the one or more tongues extending from the top segment or the one or more grooves formed within the top segment).
- the power supply 224, the tag reader 222, and the position indicator 208 are all disposed within the top segment 202.
- the injector 230 e.g., including the actuatable needle 218 and at least a portion of the second catheter 220
- the base 204 is disposed within the base 204.
- the base can be disposable. In some embodiments, the top segment can be reusable. In some embodiments, the base is a single use device provided within sterile packaging.
- the systems described herein are compliant with ANSI AAMI ISO 10993-1:2018. In some embodiments, the systems described herein conform to ISO 11608-1:2014, ISO 11608-2:2012, ISO 11608-4:2006, and/or ISO 11608-5:2012, which define specific standards for needle-based injection systems, the needle, electromechanically driven injectors, and injection systems with automated functions, respectively. In some embodiments, shipping systems and containers for the systems and system components described herein are tested using the standard methods outlined by ASTM D4169-16.
- the systems and system components comply with one or more standards associated sterilization and sterile testing processes, such as ANSI/AAMI/ISO 17665-1:2006, ANSI/AAMI/ISO 11135-1:2007, USP 27:2004, AAMI/ANSI/ISO 11737-1:2006, and ANSI/AAMI/ISO 11607:2006, which address moist heat sterilization, ethylene oxide sterilization, sterility testing, microorganism population testing, and packaging sterility, respectively.
- technology to enable the ability for the port access device to communicate with the implanted port is radio frequency identification (RFID), more near- field communication (NFC).
- RFID radio frequency identification
- NFC near- field communication
- NFC standards are based on existing RFID standards, including ISO/IEC 14443, which define physical characteristics, frequency power, signal interface, and transmission protocol. NFC specific standards include ISO/IEC 18092 and ISO/IEC 21481.
- the venous access systems described herein can be used, for example, to perform blood draws and/or to administer intravenous therapies to a patient in need thereof. Accordingly, also provided herein are methods for introducing a needle into an implanted port in a patient.
- These methods can comprise providing a patient having an implanted port described herein; positioning the patient-contacting surface of a port access device described herein against the patient at the injected position; and actuating of the needle of the port access device to advance the needle from the housing into the patient and through the needle-penetrable septum.
- the positioning step can comprise positioning the patient- contacting surface of the port access device against the patient in a region where the implantable port is located (e.g., in the approximate anatomical region where the port is located); and translocating the port access device across the patient until the position indicator indicates that the port access device is located at the injection position.
Abstract
A venous access system comprising: an implantable port comprising: a biocompatible housing having a fluid reservoir disposed therewithin; a needle-penetrable septum disposed atop the fluid reservoir; a catheter connector in fluid communication with the fluid reservoir, the catheter connector configured to be mated to a first catheter; and a wireless tag configured to transmit data to an external tag reader; and a port access device comprising: a housing having a patient-contacting surface; an injector disposed within the housing, the injector comprising an actuatable needle having an internal lumen that is fluidly connected to a second catheter; a tag reader and processor configured to communicate with the wireless tag and provide a signal to a user via a position indicator; and a power supply operatively coupled to the tag reader and processor.
Description
Venous Access Systems and Methods of Using Thereof CROSS-REFERENCE TO RELATED APPLICATIONS This application claims benefit of U.S. Provisional Application No. 63/334,911, filed April 26, 2022, which is hereby incorporated herein by reference in its entirety. BACKGROUND Implantable access ports, or simply “ports,” such as central venous access ports provide a convenient method to repeatedly deliver a substance to remote areas of the body by way of an attached catheter without utilizing a surgical procedure each time. Ports are implantable within the body and permit the infusion of medicine, parenteral solutions, blood products, or other fluids. Additionally, ports are also used for blood sampling. In common practice, a port is subcutaneously implanted within the body, and a catheter is connected to the port in fluid communication therewith. The catheter is routed to a remote area where a fluid is desired to be delivered or removed. To deliver the fluid, a caregiver locates a septum of the port by palpation of a patient’s skin. Port access is accomplished by percutaneously inserting a needle, typically a non-coring needle, through the septum of the port and into a chamber of the port. A fluid containing a drug or some other beneficial substance can then be administered by bolus injection or continuous infusion into the chamber of the port. The fluid then flows through the chamber into the catheter and finally to the remote site where the fluid is desired. Ports, particularly port septa, can be difficult to find and access once the ports are implanted under the skin. Accordingly, there is a need to facilitate locating and accessing ports and their septa, following implantation. . SUMMARY Provided herein are venous access systems. These venous access systems can comprise an implantable port and a port access device. The implantable port and the port access device can include wireless communication components (e.g., components facilitating near-field communication (NFC) between the implantable port and the port access device) which permit proper placement of the port access device relative to the
injection port to ensure proper percutaneous access to the port. This can eliminate complications, improve sterility, and/or reduce patient discomfort. In some embodiments, the implantable port can comprise a biocompatible housing having a fluid reservoir disposed therewithin; a needle-penetrable septum disposed atop the fluid reservoir; a catheter connector in fluid communication with the fluid reservoir, the catheter connector configured to be mated to a first catheter; and a wireless tag configured to transmit data to an external tag reader. In some embodiments, the wireless tag can comprise one or more passive radio- frequency identification (RFID) tags (e.g., one or more passive near-field communication (NFC) tags). In certain embodiments, the wireless tag(s) can be positioned within biocompatible housing of the implantable port, such as beneath the fluid reservoir. In some embodiments, the port access device can comprise a housing having a patient-contacting surface; an injector disposed within the housing, the injector comprising an actuatable needle having an internal lumen that is fluidly connected to a second catheter; a tag reader and processor configured to communicate with the wireless tag and provide a signal to a user via a position indicator when the port access device is positioned proximally to the implantable port at an injection position such that actuation of the needle will advance the needle from the housing through the needle-penetrable septum; and a power supply operatively coupled to the tag reader and processor. In some embodiments, the position indicator can comprise one or more LEDs which indicate to a user when the port access device is positioned in the injection position. In some embodiments, the housing further comprises a conduit through which the second catheter passes. In some embodiments, the device further comprises an injection trigger that effectuates actuation of the needle. In some embodiments, the patient-contacting surface further comprises an occlusive dressing. In certain embodiments, the occlusive dressing comprises a multilayer occlusive dressing comprising a disinfecting layer. In some embodiments, the actuatable needle comprises a Huber needle (a non-coring needle), a Trocar needle, or a pencil point needle. In certain embodiments, the actuatable needle comprises a Huber needle. In some embodiments, the housing comprises a top segment detachably coupled to a base. In certain embodiments, the top segment can slidably connect to the base.
In some embodiments, the top segment and the base can be joined using a tongue and groove joint. For example, in some cases, the top segment can include one or more tongues extending from the top segment that are slidably received into and intimately interlock with one or more grooves formed within the base. In some of these cases, the power supply can be disposed within the top segment, and the one or more tongues can further comprise electrical contacts that are electrically coupled to the power supply. In other cases, the base can include one or more tongues extending from the base that are slidably received into and intimately interlock with one or more grooves formed within the top segment. In some of these cases, the power supply is disposed within the top segment, and the one or more grooves further comprise electrical contacts that are electrically coupled to the power supply. In some embodiments, the system can further comprise a recharging station for the power supply. The top segment can be couplable to the recharging station, and coupling of the top segment to the recharging station can allow for recharging the power supply. In some cases, this can comprise wireless charging. In other embodiments, recharging can occur via electrical contacts incorporated in the top segment (e.g., electrical contacts present in the one or more tongues extending from the top segment or the one or more grooves formed within the top segment). In some embodiments, the power supply, the tag reader, and the position indicator are all disposed within the top segment. In some embodiments, the injector (e.g., including the actuatable needle and at least a portion of the second catheter), is disposed within the base. In some embodiments, the base can disposable. In some embodiments, the top segment is reusable. In some embodiments, the base is a single use device provided within sterile packaging. Also provided herein are methods for introducing a needle into an implanted port in a patient. These methods can comprise providing a patient having an implanted port described herein; positioning the patient-contacting surface of a port access device described herein against the patient at the injected position; and actuating the needle of the port access device to advance the needle from the housing into the patient and through the needle-penetrable septum.
In some embodiments, the positioning step can comprise positioning the patient- contacting surface of the port access device against the patient in a region where the implantable port is located; and translocating the port access device across the patient until the position indicator indicates that the port access device is located at the injection position. . DESCRIPTION OF DRAWINGS Figure 1 is a schematic illustration of a conventional totally implantable venous access port (TIVAP) showing both the implantable port and the method for accessing the implantable port. Figure 2 depicts a perspective view of an example implantable port described herein. Figure 3 depicts an exploded perspective view of an example implantable port described herein. Figure 4 depicts a perspective view of an example port access device described herein. Figure 5 depicts a perspective view of an example port access device described herein with the top segment and base portions decoupled. Figure 6 depicts a perspective view of an example port access device described herein. Figure 7 depicts a cross-sectional side view of an example port access device described herein. DETAILED DESCRIPTION Provided herein are venous access systems. These venous access systems can comprise an implantable port and a port access device. The implantable port and the port access device can include wireless communication components (e.g., components facilitating near-field communication (NFC) between the implantable port and the port access device) which permit proper placement of the port access device relative to the injection port to ensure proper percutaneous access to the port. The use of this targeted port access device can eliminate complications associated with port access, improve sterility, and/or reduce patient discomfort. Implanted ports, also referred to as totally implantable venous access ports (TIVAPs), are frequently used for patients who need frequent blood draws and/or who are
receiving long-term intravenous therapies, such as chemotherapy, antibiotics, blood infusions, and/or parenteral nutrition. The port itself is an imaging-compatible medical device that rests beneath the skin and connects to a catheter that runs into a nearby blood vessel. The most common and stable location for an implanted port is the right chest but they can also be found on the arm, underarm, and left chest. While ports can be implanted for weeks, months, and years, they have been known to stay in the body for as long as 10 years, and in 2016, more than 400,000 TIVAPs were sold each year in the United States. Figure 1 shows the typical form and design of an implantable port as well as the standard, manual method for accessing the port. When a patient with an implanted port requires a blood draw or an intravenous therapy, such as medication or nutrition, a health care provider can typically access the implanted port percutaneously with a needle that has an attached cannula, from which the liquid medium can be delivered. Successfully accessing an implantable port relies on many factors, including the clinician’s skill or experience, the port’s depth below the surface of the skin, the port’s orientation (such as being askew or flipped over), and the tissue type, such as extensive breast or scar tissue interference. Infections outside accessing the port is uncommon; therefore, this process plays an important role in minimizing complications due to blood- stream infections since strict adherence to procedural standards is the best mode of prevention and helps avoid the increased morbidity, mortality, costs, and hospitalization that accompany infection. The process of accessing the port is a sterile procedure so there are typically several steps and various items included in a port accessing kit. Along with many steps including disinfecting the area, holding the port underneath the skin secure while simultaneously ensuring a successful stick into the port’s septum/lumen, and remaining sterile, the current port access kits come with numerous supplies which makes it easy for a nurse or clinician to intentionally or unintentionally alter or skip a step. Further, complications can arise that may inhibit a clinician from successfully accessing a patient’s implanted port. Many ports feature three prongs on the surface of the septum. These prongs create a visible, outward impression on the skin and act as guide points for access, however, some ports are not equipped with this feature. In rare cases, the port may flip over or turn sideways, completely undermining the purpose of the prongs. A clinician may be unaware of this until attempting to access the port, resulting in unsuccessful access and the waste of materials. Additionally, if performed without the correct sterilization measures, these procedures also run the risk of
infection. With some patients having their port accessed several times a week, the risk of infection increases. The venous access systems described herein can automate the process of accessing an implanted port, increasing the convenience of the procedure for clinicians and patients, decrease the rate at which patients’ ports are unsuccessfully accessed, decreasing patient discomfort, minimizing complications, eliminating unnecessary contact with the implantation site, improving the probability that the injection site remains sterile, and/or decreasing the rate of infections. As discussed above, the venous access systems can comprise an implantable port and a port access device. By way of example, Figures 2 and 3 illustrate an example implantable port. In particular, Figure 2 depicts a perspective view of an example implantable port described herein while Figure 3 depicts an exploded perspective view of an example implantable port described herein. The implantable port 108 can include a biocompatible housing 102 having a fluid reservoir 118 disposed therewithin; a needle-penetrable septum 116 disposed atop the fluid reservoir; a catheter connector 128 in fluid communication with the fluid reservoir, the catheter connector configured to be mated to a first catheter 110; and a wireless tag 140 configured to transmit data to an external tag reader. In some embodiments, the biocompatible housing 102 can comprise a generally dome-shaped upper housing 112 and a disk-shaped lower housing 114. Upper and lower housings 112, 114 can be constructed of a body-tolerant material such as titanium or a body-compatible plastic, and sealed to one another about their periphery. The upper housing 112 can define an access port 115 to provide access to a centrally-located needle- penetrable septum 116. The septum 116 can define an upper boundary of a fluid reservoir 118. A chamber wall 120, which in some embodiments is substantially cylindrical in shape, can define the walls 120 of the fluid reservoir 118. The chamber wall 120 can be made of a rigid material, such as a biocompatible polymer or titanium. In one embodiment, the septum 116 can be constructed of a resilient, pliable material such as a self-sealing silicone rubber. In some embodiments, a fill port washer 124 can be positioned between the septum 116 and the chamber wall 120. In some embodiments, an optional needle screen (not depicted) positioned adjacent to the septum 116 can inhibit needles having a diameter larger than a given diameter from passing therethrough while allowing needles having diameters that are smaller than the
given diameter to pass therethrough. In some embodiments, a needle stop can rest on the lower housing 114. In some embodiments, an implantable catheter 110 can be connected to the implantable port 108 by sliding a proximal end 126 of the catheter 110 over a catheter connector 128 of the implantable port 108. The catheter connector 128 can be operably coupled to the upper and lower housings 112, 114, for example via an O-ring. The catheter connector 128 can be in fluid communication with the fluid reservoir 118 via conduit 132. With reference to Figures 2-3, a quantity of medicament injected percutaneously into the fluid reservoir of implantable port 108 can pass from the fluid reservoir to a distal end 134 of the catheter 110. In particular, to administer medicament, a needle filled with the medicament can be passed through a patient's skin, through the access port 115 and into the septum 116 to enter into the fluid reservoir 118. As the medicament is injected, the medicament fills the fluid reservoir 118, passes through the conduit 132 and into a lumen of the catheter 110 generally extending between the proximal end 126 and an infusion port 136 in proximity to the distal end 134. In some embodiments, the infusion port 136 can be positioned on the distal end or tip 134 of the catheter 110. Alternatively, as depicted, the infusion port 136 can be positioned proximately from the distal tip 134 along the body of the catheter 110. In some embodiments, the fluid reservoir 118 of the implantable port 108 can be impregnated or pre-loaded with one or more dosages of medicament. Thereafter, a healthcare provider can dispense one of the doses by applying pressure to the septum 116 or other movable portion of the port 108 to force the dose through the conduit 132 and into the catheter 110. If more than one dose is provided, the dosages can be separated by movable doors (not depicted) extending across the fluid reservoir 118. For example, in some embodiments, the doors can be constructed of a ferritic material and be selectively and non-invasively moved by a clinician using an external device having one or more magnets therein. The distal tip 134 of the catheter 104 can be positioned at a desired site within the patient for administration of medicament, for example within the intrathecal space of the patient, among other desirable targeted drug delivery sites. Accordingly, the catheter 110 can provide a substantially homogeneous delivery of medicament to the intrathecal space or other desirable targeted drug delivery site of a patient. As such,
the catheter 110 can be configured to extend along substantially the entire length of a patient's spinal column or along any portion thereof. In some embodiments, the catheter 110 can be configured for long term implantation into a patient and, as such, can be constructed from materials to make the catheter soft, flexible, and kink resistant. Further, in some embodiments, the catheter 110 can be configured to accommodate complex spine patients (e.g., scoliosis), the materials can provide column strength, break resistance, and stiffness so that the catheter 110 can be threadable during insertion. In some examples, the catheter 110 can be provided with an extended length so that a healthcare provider can cut the catheter 110 to a desired length for a particular patient. In order to confirm that the catheter 110 has been correctly implanted into the intrathecal space and/or is in a fully functioning form, the catheter 110 can include one or more radiopaque markings (not depicted) or components to be visible under imaging. In certain embodiments, the wireless tag(s) can be positioned within biocompatible housing of the implantable port, such as beneath the fluid reservoir. In certain embodiments, the wireless tag(s) can be centrally positioned within biocompatible housing of the implantable port, such as centrally beneath the fluid reservoir. In certain embodiments, the wireless tag(s) are enclosed or encapsulated within the housing, such that they are not in contact with biological fluids. According to preferred embodiments, the wireless tag(s) are capable of remote activation. In some embodiments, the wireless tag can comprise one or more radio-frequency identification (RFID) tags. In certain embodiments, the wireless tag can comprise one or more near-field communication (NFC) tags. In some examples, the port can comprise a single radio-frequency identification (RFID) tag (e.g., a single NFC tag). In other examples, the port can comprise a plurality of radio-frequency identification (RFID) tags (e.g., a plurality of NFC tags). In certain examples, the port can comprise an array of radio-frequency identification (RFID) tags (e.g., an array of NFC tags), for example, circumferentially disposed about the housing. The RFID tags and NFC tags can be either "passive" tags that require remote activation and power, or "active" tags. Active tags would require a power source to be imbedded within the implantable port, such as a long-lasting battery capable of remote or inductive recharging. In preferred embodiments, the RFID tags and NFC tags can be passive tags that respond to the corresponding radio frequency emitted by a tag reader. In some embodiments, the implantable port is MRI-safe.
Referring now to Figures 4-7, the port access device 200 can comprise a housing 201 having a patient-contacting surface 228. The overall shape of the housing can vary and be selected, for example, to facilitate clinical use and improve patient comfort and compliance. In some embodiments, the patient-contacting surface can comprise a cushioned or form-factored surface to improve adherence to the patient and increase comfort during use. An injector 230 is disposed within the housing. The injector can comprise an actuatable needle 218 having an internal lumen that is fluidly connected to a second catheter 220. The injector can comprise a simple mechanical or electromechanical mechanism (e.g., an angled tooth cam mechanism, such as that utilized in retractable pens; see U.S. Patent No. 3,205,863) that provides for advancement of the needle out of the housing (in the general direction indicated by the arrow in Figure 7). The actuatable needle can comprise, for example, a Huber needle (a non-coring needle), a Trocar needle, or a pencil point needle. In certain embodiments, the actuatable needle comprises a Huber needle. In some embodiments, the housing can further comprise a conduit 210 through which the second catheter 220 passes. In some embodiments, the device further comprises an injection trigger 212 (e.g., a button) that effectuates actuation of the needle. The device can further comprise a tag reader and processor 222 configured to communicate with the wireless tag and provide a signal to a user via a position indicator 208 when the port access device is positioned proximally to the implantable port at an injection position such that actuation of the needle will advance the needle from the housing through the needle-penetrable septum. In some embodiments, the position indicator 208 can comprise one or more LEDs which indicate to a user when the port access device is positioned in the injection position. For example, the position indicator can comprise one or more LEDs which illuminate when the port access device is positioned in the injection position. In some embodiments, the position indicator can comprise one or more LEDs which change color (e.g., from red to green) when the port access device is positioned in or reaches the injection position. The device can further comprise a power supply 224 operatively coupled to the tag reader and processor 222. In some embodiments, the power supply 224 can further be operatively coupled to the position indicator 208.
In some embodiments, the patient-contacting surface further comprises an occlusive dressing. In certain embodiments, the occlusive dressing comprises a multilayer occlusive dressing comprising a disinfecting layer (e.g., ChloraPrep). In some embodiments, the housing 201 can comprise a top segment 202 detachably coupled to a base 204. In certain embodiments, the top segment 202 can slidably connect to the base 204. In some embodiments, the top segment 202 and the base 204 can be joined using a tongue and groove joint or sliding dovetail joint. For example, in some cases, the top segment 202 can include one or more tongues 206 extending from the top segment that are slidably received into and intimately interlock with one or more grooves 214 formed within the base 204. In other cases, the base can include one or more tongues extending from the base that are slidably received into and intimately interlock with one or more grooves formed within the top segment. In some of the embodiments described above, the tongues can be dovetailed, so prevent the top segment and the base from separating or lifting away from the base when the device is lifted by the top segment. In some of these cases, the power supply 224 can be disposed within the top segment 202, and the one or more tongues 206 can further comprise electrical contacts 216 that are electrically coupled to the power supply. In other cases, the power supply 224 can be disposed within the top segment 202, and the one or more grooves can further comprise electrical contacts that are electrically coupled to the power supply. In some embodiments, the system can further comprise a recharging station (not shown) for the power supply. The top segment can be couplable to the recharging station, and coupling of the top segment to the recharging station can allow for recharging the power supply. In some cases, this can comprise wireless charging. In other embodiments, recharging can occur via electrical contacts incorporated in the top segment (e.g., electrical contacts present in the one or more tongues extending from the top segment or the one or more grooves formed within the top segment). In some embodiments, the power supply 224, the tag reader 222, and the position indicator 208 are all disposed within the top segment 202. In some embodiments, the injector 230 (e.g., including the actuatable needle 218 and at least a portion of the second catheter 220) is disposed within the base 204. In some embodiments, the base can be disposable. In some embodiments, the top segment can be reusable.
In some embodiments, the base is a single use device provided within sterile packaging. In some embodiments, the systems described herein are compliant with ANSI AAMI ISO 10993-1:2018. In some embodiments, the systems described herein conform to ISO 11608-1:2014, ISO 11608-2:2012, ISO 11608-4:2006, and/or ISO 11608-5:2012, which define specific standards for needle-based injection systems, the needle, electromechanically driven injectors, and injection systems with automated functions, respectively. In some embodiments, shipping systems and containers for the systems and system components described herein are tested using the standard methods outlined by ASTM D4169-16. In some embodiments, the systems and system components comply with one or more standards associated sterilization and sterile testing processes, such as ANSI/AAMI/ISO 17665-1:2006, ANSI/AAMI/ISO 11135-1:2007, USP 27:2004, AAMI/ANSI/ISO 11737-1:2006, and ANSI/AAMI/ISO 11607:2006, which address moist heat sterilization, ethylene oxide sterilization, sterility testing, microorganism population testing, and packaging sterility, respectively. In some embodiments, technology to enable the ability for the port access device to communicate with the implanted port is radio frequency identification (RFID), more near- field communication (NFC). NFC standards are based on existing RFID standards, including ISO/IEC 14443, which define physical characteristics, frequency power, signal interface, and transmission protocol. NFC specific standards include ISO/IEC 18092 and ISO/IEC 21481. The venous access systems described herein can be used, for example, to perform blood draws and/or to administer intravenous therapies to a patient in need thereof. Accordingly, also provided herein are methods for introducing a needle into an implanted port in a patient. These methods can comprise providing a patient having an implanted port described herein; positioning the patient-contacting surface of a port access device described herein against the patient at the injected position; and actuating of the needle of the port access device to advance the needle from the housing into the patient and through the needle-penetrable septum. In some embodiments, the positioning step can comprise positioning the patient- contacting surface of the port access device against the patient in a region where the implantable port is located (e.g., in the approximate anatomical region where the port is
located); and translocating the port access device across the patient until the position indicator indicates that the port access device is located at the injection position. The systems and methods of the appended claims are not limited in scope by the specific compounds, compositions, and methods described herein, which are intended as illustrations of a few aspects of the claims. Any systems and methods that are functionally equivalent are intended to fall within the scope of the claims. Various modifications of the systems and methods in addition to those shown and described herein are intended to fall within the scope of the appended claims. Further, while only certain representative devices, components and method steps disclosed herein are specifically described, other combinations of the devices, components, and method steps also are intended to fall within the scope of the appended claims, even if not specifically recited. Thus, a combination of steps, elements, components, or constituents may be explicitly mentioned herein or less, however, other combinations of steps, elements, components, and constituents are included, even though not explicitly stated. The term “comprising” and variations thereof as used herein is used synonymously with the term “including” and variations thereof and are open, non-limiting terms. Although the terms “comprising” and “including” have been used herein to describe various embodiments, the terms “consisting essentially of” and “consisting of” can be used in place of “comprising” and “including” to provide for more specific embodiments of the invention and are also disclosed. Other than where noted, all numbers expressing geometries, dimensions, and so forth used in the specification and claims are to be understood at the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, to be construed in light of the number of significant digits and ordinary rounding approaches. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of skill in the art to which the disclosed invention belongs. Publications cited herein and the materials for which they are cited are specifically incorporated by reference.
Claims
WHAT IS CLAIMED IS: 1. A venous access system comprising: (a) an implantable port comprising: (i) a biocompatible housing having a fluid reservoir disposed therewithin; (ii) a needle-penetrable septum disposed atop the fluid reservoir; (iii) a catheter connector in fluid communication with the fluid reservoir, the catheter connector configured to be mated to a first catheter; and (iv) a wireless tag configured to transmit data to an an external tag reader; and (b) a port access device comprising: (i) a housing having a patient-contacting surface; (ii) an injector disposed within the housing, the injector comprising an actuatable needle having an internal lumen that is fluidly connected to a second catheter; (iii) a tag reader and processor configured to communicate with the wireless tag and and provide a signial to a user via a position indicator when the port access device is positioned proximally to the implantable port at an injection position such that actuation of the needle will advance the needle from the housing through the needle-penetrable septum; and (iv) a power supply operatively coupled to the tag reader and processor.
2. The system of claim 1, wherein the wireless tag comprises one or more passive radio-frequency identification (RFID) tags.
3. The system of any of claims 1-2, wherein the wireless tag comprises one or more passive near-field communication (NFC) tags.
4. The system of any of claims 1-3, wherein wireless tag is positioned within biocompatible housing of the implantable port.
5. The system of claim 4, wherein the wireless tag is disposed beneath the fluid reservoir.
6. The system of any of claims 1-5, wherein the position indicator comprises one or more LEDs which indicate to a user when the port access device is positioned in the injection position.
7. The system of any of claims 1-6, wherein the housing further comprises a conduit through which the second catheter passes.
8. The system of any of claims 1-7, wherein the device further comprises an injection trigger that effectuates actuation of the needle.
9. The system of any of claims 1-8, wherein the patient-contacting surface further comprises an occlusive dressing.
10. The system of claim 9, wherein the occlusive dressing comprises a multilayer occlusive dressing comprising a disinfecting layer.
11. The system of any of claims 1-10, wherein the actuatable needle comprises a Huber needle (a non-coring needle), a Trocar needle, or a pencil point needle.
12. The system of any of claims 1-11, wherein the housing comprises a top segment detachably coupled to a base.
13. The system of claim 12, wherein the top segment slidably connects to the base.
14. The system of claim 13, wherein the top segment includes one or more tongues extending from the top segment that are slidably received into and intimately interlock with one or more grooves formed within the base.
15. The system of claim 14, wherein the power supply is disposed within the top segment, and wherein the one or more tongues further comprise electrical contacts that are electrically coupled to the power supply.
16. The system of claim 13, wherein the base includes one or more tongues extending from the base that are slidably received into and intimately interlock with one or more grooves formed within the top segment.
17. The system of claim 16, wherein the power supply is disposed within the top segment, and wherein the one or more grooves further comprise electrical contacts that are electrically coupled to the power supply.
18. The system of any of claims 12-17, wherein the system further comprises a recharging station for the power supply, wherein the top segment is couplable to the recharging station, and wherein coupling of the top segment to the recharging station recharges the power supply.
19. The system of any of claims 12-18, wherein the power supply, the tag reader, and the position indicator are all disposed within the top segment.
20. The system of any of claims 12-19, wherein the injector is disposed within the base.
21. The system of any of claims 12-20, wherein the base is disposable.
22. The system of any of claims 12-21, wherein the base is provided within sterile packaging.
23. A method for introducing a needle into an implanted port in a patient, said method comprising: (a) providing the patient having the implanted port, the implanted port comprising: (i) a biocompatible housing having a fluid reservoir disposed therewithin; (ii) a needle-penetrable septum disposed atop the fluid reservoir; (iii) a catheter connector in fluid communication with the fluid reservoir, the catheter connector configured to be mated to a first catheter; and (iv) a wireless tag configured to transmit data to an external tag reader; (b) providing a port access device comprising: (i) a housing having a patient-contacting surface;
(ii) an injector disposed within the housing, the injector comprising an actuatable needle having an internal lumen that is fluidly connected to a second catheter; (iii) a tag reader and processor configured to communicate with the wireless tag and provide a signal to a user via a position indicator when the port access device is positioned proximally to the implantable port at an injection position such that actuation of the needle will advance the needle from the housing through the needle-penetrable septum; and (iv) a power supply operatively coupled to the tag reader and processor; (c) positioning the patient-contacting surface of the port access device against the patient at the injected position; and (d) actuating the needle of the port access device to advance the needle from the housing into the patient and through the needle-penetrable septum.
24. The method of claim 23, wherein step (c) comprises positioning the patient-contacting surface of the port access device against the patient in a region where the implantable port is located; and translocating the port access device across the patient until the position indicator indicates that the port access device is located at the injection position.
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