阅读说明：本技术 植入式输液港、植入式输液港检测装置及其方法 (Implantable infusion port, implantable infusion port detection device and method ) 是由 A·J·钱杜斯克 P·郑 S·贾拉勒戴恩 J·D·库克斯 J·B·考克斯 于 2019-07-12 设计创作，主要内容包括：本文公开了一种植入式输液港和一种植入式输液港检测装置(“IPDD”)。植入式输液港包括壳体和覆盖在壳体的一部分上的穿刺膜。壳体或穿刺膜中的至少一者结合造影剂,以用于当植入式输液港被植入患者体内时定位植入式输液港的穿刺膜。IPDD包括光源、光检测器以及显示器,显示器被配置为显示植入式输液港的存在。光源被配置为发射近红外(“NIR”)波长范围内的光作为入射光,以用于被造影剂吸收。光检测器被配置为检测NIR波长范围内的光,该光包括由造影剂发射的荧光。显示器被配置为当光检测器检测到来自造影剂的荧光时显示植入式输液港的存在。(An implantable port and an implantable port detection device ('IPDD') are disclosed. The implantable port includes a housing and a puncture membrane covering a portion of the housing. At least one of the housing or the puncture membrane incorporates a contrast agent for locating the puncture membrane of the implantable port when the implantable port is implanted in a patient. The IPDD includes a light source, a light detector, and a display configured to display the presence of the implanted infusion port. The light source is configured to emit light in a near infrared ("NIR") wavelength range as incident light for absorption by the contrast agent. The light detector is configured to detect light in the NIR wavelength range, which light includes fluorescence emitted by the contrast agent. The display is configured to display the presence of the implanted port when the light detector detects fluorescence from the contrast agent.)

1. An implantable port comprising:

a housing including a chamber, the housing having a main opening to the chamber; and

a puncturing membrane covering the main opening of the housing,

wherein one or more portions of the implantable port incorporate a contrast agent for locating the puncture membrane of the implantable port in vivo by photoexcitation and detection of the contrast agent.

2. The implantable port of claim 1, wherein the puncture membrane of the implantable port binds the contrast agent.

3. The implantable port of claim 1, wherein the housing of the implantable port incorporates the contrast agent at least around the primary opening of the housing.

4. The implantable port of any one of claims 1 to 3, wherein the contrast agent comprises nanoparticles, quantum dots, one or more fluorescent dyes, or a combination thereof.

5. The implantable port of any one of claims 1 to 3, wherein the contrast agent comprises an up-converting nanoparticle comprising a lanthanide or actinide doped transition metal.

6. The implantable port of any one of claims 1 to 3, wherein the contrast agent comprises a core-shell nanoparticle.

7. The implantable port of any one of claims 1 to 3, wherein the contrast agent comprises gold nanoparticles configured to absorb incident light in a near infrared ("NIR") wavelength range and emit fluorescence light in the NIR wavelength range.

8. The implantable port of claim 7, wherein said gold nanoparticles comprise a capping ligand derived from biotin, methoxypolyethylene glycol, or citric acid.

9. The implantable port of any one of claims 1 to 8, wherein the implantable port comprising the contrast agent is stable to conditions associated with autoclave-based sterilization at temperatures up to at least 60 ℃.

10. The implantable port of any one of claims 1 to 9, wherein the housing has structural integrity for mechanically assisted pressurized injection to achieve a desired flow rate of injectate through the implantable port.

11. A catheter assembly, comprising:

a) an implantable port comprising

A housing comprising a chamber, the housing having a primary opening and a secondary opening to the chamber;

a puncturing film covering the main opening of the housing, an

A handle comprising a handle lumen fluidly connected to the chamber through the secondary opening of the housing,

wherein one or more portions of the implantable port incorporate a contrast agent for locating the puncture membrane of the implantable port in vivo by photoexcitation and detection of the contrast agent; and

b) a catheter comprising a tip portion configured to slide over the handle of the implantable port, the catheter having a catheter lumen in fluid communication with the chamber of the implantable port via the handle lumen; and

c) a catheter lock configured to slide over the tip portion of the catheter on the handle of the implantable port, thereby locking the catheter on the handle of the implantable port.

12. The catheter assembly of claim 11, wherein the puncture membrane of the implantable port incorporates the contrast agent or the housing of the implantable port incorporates the contrast agent at least around the primary opening of the housing.

13. The catheter assembly of claim 11 or 12, wherein the contrast agent comprises gold nanoparticles configured to absorb incident light in a near infrared ("NIR") wavelength range and emit fluorescence in the NIR wavelength range.

14. The catheter assembly of claim 13, wherein the gold nanoparticles comprise a capping ligand derived from biotin, methoxypolyethylene glycol, or citric acid.

15. The catheter assembly of any one of claims 11-14, wherein the implantable port including the contrast agent is stable to conditions associated with autoclave-based sterilization at temperatures up to at least 60 ℃.

16. The catheter assembly of any one of claims 11-15, wherein the housing of the implantable port has structural integrity for mechanically assisted pressurized injection to achieve a desired flow rate of injectate through the implantable port.

17. An implantable port detection device ("IPDD") comprising:

a light source configured to emit light having one or more wavelengths in the near-infrared ("NIR") wavelength range for absorption by a contrast agent incorporated in one or more portions of the implantable port as incident light;

a photodetector configured to detect light having one or more same or different wavelengths within the NIR wavelength range, the light comprising fluorescent light emitted by the contrast agent after the incident light is absorbed by the contrast agent; and

a display configured to display the presence of the implanted port when the light detector detects the fluorescence from the contrast agent.

18. The IPDD of claim 17, wherein the light detector is a NIR sensitive camera configured to capture an image or video of at least a portion of an environment comprising the implanted port along with the fluorescence from the contrast agent when the fluorescence is present.

19. The IPDD of claim 18, wherein the display is configured to display the image or video, thereby providing presence of the implanted port.

20. The IPDD of claim 18 or 19, further comprising: a filter overlying an aperture of the camera, the filter configured to cut wavelengths of interfering light to improve contrast in the image or the video.

21. The IPDD of claim 20, wherein the filter is a dichroic filter configured as a bandpass filter or a long-pass filter that cuts wavelengths shorter than about 600 nm.

22. The IPDD of any of claims 17 to 21, further comprising: a battery and a converter configured to convert alternating current ("AC") to direct current ("DC") to charge the battery from a common AC power source.

23. The IPDD of any of claims 17 to 22, wherein the IPDD is a handheld device.

24. An implantable port detection system comprising:

a) an implantable port comprising

A housing including a chamber, the housing having a main opening to the chamber; and

a puncturing membrane covering the main opening of the housing,

wherein one or more portions of the implantable port incorporate a contrast agent for locating the puncture membrane of the implantable port when the implantable port is implanted in a patient; and

b) an implanted port detection device ("IPDD") comprising:

a light source configured to emit light having one or more wavelengths in the near-infrared ("NIR") wavelength range for absorption by the contrast agent incorporated in the one or more portions of the implantable port as incident light;

a photodetector configured to detect light having one or more same or different wavelengths within the NIR wavelength range, the light comprising fluorescent light emitted by the contrast agent after the incident light is absorbed by the contrast agent; and

a display configured to display the presence of the implanted port of infusion when the light detector detects the fluorescence from the contrast agent.

25. The implantable port detection system of claim 24, wherein the puncture membrane of the implantable port incorporates the contrast agent or the housing of the implantable port incorporates the contrast agent at least around the primary opening of the housing.

26. The implantable port detection system of claim 24 or 25, wherein the contrast agent comprises gold nanoparticles configured to absorb the incident light having the one or more wavelengths within the NIR wavelength range and emit the fluorescent light having the one or more same or different wavelengths within the NIR wavelength range.

27. The implantable port detection system of claim 26, wherein the one or more wavelengths of the incident light correspond to peak absorption of the gold nanoparticles in the NIR wavelength range.

28. The implantable port infusion detection system according to claim 26 or 27, wherein said gold nanoparticles comprise a capping ligand derived from biotin, methoxypolyethylene glycol or citric acid.

29. The implantable port detection system of any one of claims 26 to 28, wherein the light detector is a NIR sensitive camera configured to capture an image or video of at least a portion of the patient's body surface along with the fluorescence from the gold nanoparticles when the fluorescence is present, and wherein the display is configured to display the image or video, thereby providing for the presence of the port implanted within the patient.

30. The implantable port infusion detection system of claim 29, further comprising: a filter positioned between the camera and the patient, the filter configured to cut wavelengths of interfering light to improve contrast in the image or the video, wherein the filter is a dichroic filter configured to cut band pass filters or long pass filters of wavelengths shorter than about 600 nm.

31. The implantable port infusion detection system according to any one of claims 24 to 30, further comprising: a battery and a converter configured to convert alternating current ("AC") to direct current ("DC") to charge the battery via a universal AC power source, wherein the IPDD is a handheld device.

32. A method for an implantable port detection system, comprising:

emitting light from a light source of an implanted port detection device ("IPDD") as incident light,

wherein the incident light has one or more wavelengths in the near infrared ("NIR") wavelength range;

detecting light with a light detector of the IPDD, the light including fluorescence emitted by a contrast agent incorporated in an implanted port implanted in a patient after the incident light is absorbed by the contrast agent,

wherein the fluorescence has one or more same or different wavelengths within the NIR wavelength range; and

displaying the presence of the port implanted in the patient when the light detector detects the fluorescence from the contrast agent.

33. The method of claim 32, wherein the puncture membrane of the implantable port incorporates the contrast agent or the housing of the implantable port incorporates the contrast agent at least around a primary opening of the housing covered by the puncture membrane.

34. The method of claim 33, further comprising: piercing the puncture membrane of the implantable port with a centerless needle to collect a blood sample from a chamber of the implantable port or to deliver a therapeutic agent to the chamber of the implantable port.

35. The method of any one of claims 32 to 34, wherein the contrast agent comprises gold nanoparticles configured to absorb the incident light having the one or more wavelengths within the NIR wavelength range and emit the fluorescent light having the one or more same or different wavelengths within the NIR wavelength range.

36. The method of any one of claims 32 to 35, wherein the light detector is a NIR sensitive camera configured to capture images or video, and wherein displaying the presence of the port implanted in the patient comprises displaying at least a portion of a body surface of the patient along with images or video of the fluorescence emitted by the contrast agent incorporated in the implanted port when the fluorescence is present.

37. The method of any of claims 32 to 36, further comprising: removing the implanted port implanted in the patient.

Background

Implantable access ports, or simply "ports," such as central venous access ports, provide an easy way to repeatedly deliver substances to distal regions of the body via attached catheters without the need to use surgery each time. The port may be implanted in the body and allow for the infusion of drugs, parenteral solutions, blood products or other fluids. In addition, port infusion is also used for blood sampling. In common practice, the port is implanted subcutaneously and the catheter is connected in fluid communication therewith to the port. The catheter is guided to the distal region where fluid delivery or removal is desired. To deliver the fluid, the caregiver locates the puncture membrane (septium) of the port by palpating the patient's skin. Access to the port is achieved by a percutaneous insertion needle (usually a centerless needle) through a puncture membrane of the port and into a chamber of the port. The fluid containing the drug or some other beneficial substance can then be administered into the chamber of the port by bolus injection or continuous infusion. The fluid then flows through the chamber into the catheter and eventually to the distal location where the fluid is needed.

Once the port is implanted under the skin, it may be difficult to find the port, and in particular the port piercing membrane. Therefore, there is a need to facilitate the finding of medical devices (e.g., ports) and their puncture membranes after such medical devices are implanted. At least an implantable port, an implantable port detection device, and methods thereof are disclosed.

Disclosure of Invention

An implantable port is disclosed herein that, in some embodiments, includes a housing and a puncture membrane overlying the housing. The housing includes a chamber having a main opening to the chamber. The puncture membrane covers the main opening of the housing. One or more portions of the implantable port incorporate contrast agents for locating a puncture membrane of the implantable port in vivo by photoelectric excitation and detection of the contrast agents.

In some embodiments, the puncture membrane of the implantable port is conjugated with a contrast agent.

In some embodiments, the housing of the implantable port incorporates contrast media at least around the main opening of the housing.

In some embodiments, the contrast agent comprises nanoparticles, quantum dots, one or more fluorescent dyes, or a combination thereof.

In some embodiments, the contrast agent comprises an upconverting nanoparticle comprising a lanthanide or actinide doped transition metal.

In some embodiments, the contrast agent comprises a core-shell nanoparticle.

In some embodiments, the contrast agent comprises gold nanoparticles configured to absorb incident light in the NIR wavelength range and emit fluorescence in the near infrared wavelength range.

In some embodiments, the gold nanoparticles comprise a capping ligand derived from biotin, methoxypolyethylene glycol, or citric acid.

In some embodiments, the implantable port including the contrast agent is stable to conditions associated with autoclave-based sterilization at temperatures up to at least 60 ℃.

In some embodiments, the housing has structural integrity for mechanically assisted pressurized injection to achieve a desired flow rate of injectate through the implantable port.

Also disclosed herein is a catheter assembly that, in some embodiments, includes an implantable port, a catheter, and a catheter lock configured to lock the catheter on the implantable port. The implantable port includes a housing, a puncture membrane overlying the housing, and a handle extending from the housing. The housing includes a chamber having a primary opening and a secondary opening into the chamber. The puncture membrane covers the main opening of the housing. The handle includes a handle lumen fluidly connected to the chamber through the secondary opening of the housing. One or more portions of the implantable port incorporate contrast agents for locating a puncture membrane of the implantable port in vivo by photoelectric excitation and detection of the contrast agents. The catheter includes a tip portion configured to slide over a handle of the implantable port. The catheter has a catheter lumen in fluid communication with the chamber of the implantable port via the handle lumen. The catheter lock is configured to slide over a tip portion of the catheter on the handle of the implantable port, thereby locking the catheter on the handle of the implantable port.

In some embodiments, the puncture membrane of the implantable port is conjugated with a contrast agent. Alternatively, the housing of the implantable port incorporates contrast media at least around the main opening of the housing.

In some embodiments, the catheter lock, or both the catheter and the catheter lock incorporate a contrast agent.

In some embodiments, the contrast agent comprises gold nanoparticles configured to absorb incident light in the NIR wavelength range and emit fluorescence in the NIR wavelength range.

In some embodiments, the gold nanoparticles comprise a capping ligand derived from biotin, methoxypolyethylene glycol, or citric acid.

In some embodiments, the implantable port including the contrast agent is stable to conditions associated with autoclave-based sterilization at temperatures up to at least 60 ℃.

In some embodiments, the housing of the implantable port has structural integrity for mechanically assisted pressurized injection to achieve a desired flow rate of injectate through the implantable port.

Also disclosed herein is an implantable port detection device ("IPDD"), which in some embodiments includes a light source, a light detector, and a display configured to display the presence of an implantable port. The light source is configured to emit light having one or more wavelengths in the NIR wavelength range as incident light for absorption by a contrast agent incorporated in one or more portions of the implantable port. A light detector configured to detect light having one or more same or different wavelengths in the NIR wavelength range, the light comprising fluorescence emitted by the contrast agent after the incident light is absorbed by the contrast agent. The display is configured to display the presence of the implanted port when the light detector detects fluorescence from the contrast agent.

In some embodiments, the light detector is a NIR sensitive camera configured to capture an image or video of at least a portion of the environment comprising the implanted port along with fluorescence from the contrast agent when fluorescence is present.

In some embodiments, the display is configured to display an image or video, thereby providing the presence of the implanted port.

In some embodiments, the IPDD further comprises a filter overlying the aperture of the camera, the filter configured to cut off the wavelength of the interfering light to improve contrast in the image or video.

In some embodiments, the filter is a dichroic filter configured as a band pass filter or a long pass filter that cuts wavelengths shorter than about 600 nm.

In some embodiments, the implantable port detection device further comprises a battery and a converter for charging the battery. The converter is configured to convert alternating current ("AC") to direct current ("DC") to charge the battery via a common AC power source.

In some embodiments, the IPDD is a handheld device.

Also disclosed herein is an implantable port detection system, which in some embodiments includes an implantable port and an IPDD. The implantable port includes a housing including a chamber having a main opening into the chamber. The puncture membrane covers the main opening of the housing. One or more portions of the implantable port incorporate contrast media for locating a puncture membrane of the implantable port when the implantable port is implanted in a patient. The IPDD includes a light source, a light detector, and a display configured to display the presence of the implanted infusion port. The light source is configured to emit light having one or more wavelengths in the NIR wavelength range as incident light for absorption by a contrast agent incorporated in one or more portions of the implantable port. The light detector is configured to detect light having one or more same or different wavelengths in the NIR wavelength range, the light comprising fluorescent light emitted by the contrast agent after the incident light is absorbed by the contrast agent. The display is configured to display the presence of the implanted port when the light detector detects fluorescence from the contrast agent.

In some embodiments, the puncture membrane of the implantable port is conjugated with a contrast agent. Alternatively, the housing of the implantable port incorporates contrast media at least around the main opening of the housing.

In some embodiments, the contrast agent comprises gold nanoparticles configured to absorb incident light having one or more wavelengths in the NIR wavelength range and emit fluorescent light having one or more same or different wavelengths in the NIR wavelength range.

In some embodiments, the one or more wavelengths of incident light correspond to a peak absorption of the gold nanoparticles in the NIR wavelength range.

In some embodiments, the gold nanoparticles comprise a capping ligand derived from biotin, methoxypolyethylene glycol, or citric acid.

In some embodiments, the light detector is a NIR sensitive camera configured to capture an image or video of at least a portion of the body surface of the patient along with fluorescence from the gold nanoparticles when fluorescence is present. The display is configured to display an image or video, thereby providing the presence of the access port implanted in the patient.

In some embodiments, the implantable port detection system further comprises a filter positioned between the camera and the patient, the filter configured to cut off wavelengths of the interfering light to improve contrast in the image or video. The filter is a dichroic filter configured as a bandpass filter or a long-pass filter that cuts wavelengths shorter than about 600 nm.

In some embodiments, the implantable port detection system further comprises a battery and a converter for charging the battery. The converter is configured to convert alternating current ("AC") to direct current ("DC") to charge the battery via a common AC power source.

In some embodiments, the IPDD is a handheld device.

Also disclosed herein is a method for a port detection system, which in some embodiments includes: emitting light from a light source of the IPDD as incident light, detecting light with a light detector of the IPDD, the light including fluorescence from an implanted port implanted in the patient, and indicating the presence of the implanted port in the patient. The incident light emitted from the light source of the IPDD has one or more wavelengths in the NIR wavelength range. The fluorescence from the implanted port is the fluorescence emitted by the contrast agent after the incident light is absorbed by the contrast agent incorporated in the implanted port. The fluorescence light has one or more of the same or different wavelengths in the NIR wavelength range. When the light detector detects fluorescence from the contrast agent, the presence of an implanted port in the patient is indicated.

In some embodiments, the puncture membrane of the implantable port is conjugated with a contrast agent. Alternatively, the housing of the implantable port incorporates contrast media at least around the main opening of the housing covered by the puncture membrane.

In some embodiments, the method further comprises piercing a puncture membrane of the implantable port with a centerless needle to collect a blood sample from or deliver a therapeutic agent to a chamber of the implantable port.

In some embodiments, the contrast agent comprises gold nanoparticles configured to absorb incident light having one or more wavelengths in the NIR wavelength range and emit fluorescent light having one or more same or different wavelengths in the NIR wavelength range.

In some embodiments, the light detector is a NIR sensitive camera configured to capture images or video. Displaying the presence of the port implanted in the patient includes displaying at least a portion of a body surface of the patient along with an image or video of fluorescence emitted by a contrast agent incorporated in the implanted port when fluorescence is present.

In some embodiments, the method further comprises removing the implantable port implanted in the patient.

These and other features of the concepts provided herein will become more readily apparent to those skilled in the art from the following description and drawings, of which specific embodiments are disclosed in greater detail.

Drawings

Fig. 1 illustrates an implanted port detection system for finding an implanted port implanted in a patient according to some embodiments.

Fig. 2 illustrates a hierarchical view of an implanted port detection system according to some embodiments.

Fig. 3A illustrates a side view of a catheter assembly including an implantable port according to some embodiments.

Fig. 3B illustrates a top view of a catheter assembly including an implantable port, according to some embodiments.

Fig. 3C illustrates a top view of a catheter assembly including an implantable port, according to some embodiments.

Fig. 4A shows an absorption spectrum of gold nanospheres according to some embodiments.

Fig. 4B shows an absorption spectrum of gold nanorods according to some embodiments.

Fig. 5 illustrates an implanted port detection apparatus according to some embodiments.

Fig. 6 illustrates modules of an implanted port detection apparatus according to some embodiments.

Fig. 7 illustrates a transmission curve of a filter of an implanted port detection device according to some embodiments.

Fig. 8 illustrates a method for an implanted port detection system according to some embodiments.

Detailed Description

Before some specific embodiments are disclosed in more detail, it is to be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that particular embodiments disclosed herein may have features that can be readily separated from the particular embodiments and optionally combined with or substituted for the features of any of the numerous other embodiments disclosed herein.

With respect to the terminology used herein, it is also to be understood that these terminology is used for the purpose of describing some particular embodiments, and that these terminology is not intended to limit the scope of the concepts provided herein. Ordinals (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not provide sequence or numerical limitations. For example, "first," "second," and "third" features or steps need not necessarily occur in sequence, and particular embodiments that include such features or steps are not necessarily limited to these three features or steps. Labels, such as "left," "right," "front," "back," "top," "bottom," "forward," "rearward," "clockwise," "counterclockwise," "up," "down," or other similar terms, such as "upper," "lower," "back," "front," "vertical," "horizontal," "near," "far," etc., are used for convenience and are not intended to imply any particular fixed position, orientation, or direction, for example. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise.

With respect to "proximal," for example, a "proximal portion" or "proximal portion" of a catheter as disclosed herein includes the portion of the catheter that should be proximal to a clinician when the catheter is used with a patient. Likewise, for example, the "proximal length" of a catheter includes the length of the catheter that should be proximal to the clinician when the catheter is used with a patient. For example, the "proximal end" of a catheter includes the end of the catheter that should be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of the catheter may comprise the proximal end of the catheter; however, the proximal portion, or proximal length of the catheter need not comprise the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, or proximal length of the catheter is not the distal portion or end length of the catheter.

By "distal", for example, a "distal portion" or "distal portion" of the catheter includes the portion of the catheter that should be near or within the patient when the catheter is used with the patient. Likewise, for example, a "distal length" of a catheter includes the length of the catheter that should be near or within a patient when the catheter is used with the patient. For example, the "distal end" of a catheter includes the end of the catheter that should be near or within a patient when the catheter is used with the patient. The distal portion, or distal length of the catheter may comprise the distal end of the catheter; however, the distal portion, or distal length of the catheter need not comprise the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, or distal length of the catheter is not the tip portion or length of the catheter.

Abbreviations, acronyms, and the like, as used herein include near infrared ("NIR"), implanted port detection device ("IPDD"), alternating current ("AC"), direct current ("DC"), charge coupled device ("CCD"), graphical user interface ("GUI"), and light emitting diode ("LED").

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

Once the port is implanted under the skin, it may be difficult to find the port, and in particular the port piercing membrane. Therefore, there is a need to facilitate the finding of medical devices (e.g., ports) and their puncture membranes after such medical devices are implanted. Accordingly, various implantable port detection systems, catheter assemblies including implantable ports, and implantable port detection devices are presented below. Methods related to the foregoing are also set forth below.

Implanted transfusion port detection system

Fig. 1 illustrates an implantable port detection system 100 for finding an implantable port 310 implanted in a patient P, according to some embodiments. Fig. 2 illustrates a hierarchical view of the implanted port detection system 100 according to some embodiments.

As shown, in some embodiments, the implanted port detection system 100 includes an implanted port detection device ("IPDD") 500 and a catheter assembly 300 that includes an implanted port 310. As set forth in more detail below, one or more portions of the implantable port 310 incorporate a contrast agent 317 (see fig. 3A-3C) for locating the puncture membrane 314 (see fig. 3A-3C) of the implantable port 310 when the implantable port 310 is implanted in the patient P. The IPDD 500 comprises a light source 642 (see also fig. 6), the light source 642 being configured to emit light having one or more wavelengths in the near infrared ("NIR") wavelength range as incident light hv_iIncident light hv_iFor absorption by the contrast agent 317 incorporated into one or more portions of the implanted port 310. The incident light has one or more wavelengths that are at or near the peak absorption of the contrast agent 317. IPDD 500 further comprises a light detector 644 (see fig. 6), which light detector 644 is configured to detect light having one or more of the same or different wavelengths in the NIR wavelength range, including fluorescent light hv emitted by contrast agent 317 after incident light is absorbed by contrast agent 317_i. The IPDD 500 further comprises a display 520 (see also fig. 5), the display 520 being configured to show the presence of the implanted port 310 when the light detector 644 detects fluorescence from the contrast agent 317.

Catheter assembly including an implantable port

Fig. 3A illustrates a side view of a catheter assembly 300 including an implantable port 310 according to some embodiments. Fig. 3B and 3C illustrate top views of a catheter assembly 300 including an implantable port 310 according to some embodiments.

As shown, in some embodiments, the catheter assembly 300 includes an implantable port 310, a catheter 320, and a catheter lock 330, the catheter lock 330 configured to lock the catheter 320 to the implantable port 310. As set forth in more detail below, the implantable port 310 includes a housing 312 and a hollow handle 318 extending from the housing 312. The catheter 320 includes a tip portion configured to slide over the handle 318 of the implantable port 310. The catheter 320 has a catheter lumen 322 in fluid communication with the chamber 316 of the implantable port 310 via a handle lumen (not shown) of the handle 318. The catheter lock 330 is configured to slide over the end portion of the catheter 320 on the handle 318 of the implantable port 310, thereby locking the catheter 320 to the handle 318 of the implantable port 310.

When one or more portions of the implantable port 310 incorporate a contrast agent 317 for positioning the puncture membrane 314 of the implantable port 310, the catheter 320, the catheter lock 330, or both the catheter 320 and the catheter lock 330 may incorporate the same or different contrast agents. Incorporating such contrast media in the catheter 320 or catheter lock 330 effectively enlarges the area over which the contrast media is distributed on the patient P. This may facilitate searching for an implanted port of infusion (e.g., the implanted port 310) in certain bodies (e.g., obese patients). For example, once a catheter (e.g., catheter 320) is found, for example, that incorporates a contrast agent (e.g., contrast agent 317), the clinician may follow the catheter to the implanted port by illuminating it. The clinician may then identify the puncture membrane of the implanted port by luminescence of the contrast agent in one or more portions of the implanted port.

Implanted transfusion port

Likewise, fig. 3A illustrates a side view of a catheter assembly 300 including an implantable port 310, according to some embodiments. Fig. 3B and 3C illustrate top views of a catheter assembly 300 including an implantable port 310 in which contrast 317 is incorporated in different ways, according to some embodiments.

As shown, in some embodiments, the implantable port 310 includes a housing 312, a puncture membrane 314 covering at least a portion of the housing 312, and a handle 318 extending from the housing 312. The housing 312 may have structural integrity for mechanically assisted pressurized injection to achieve a desired flow rate of injectate through the implanted port 310. The housing 312 includes a chamber 316 for such injection, the housing 312 having a primary opening to the chamber 316 and a secondary opening to the chamber 316. A piercing membrane 314 overlies the main opening of the housing 312, thereby closing or sealing the chamber 316 and requiring a needle to access the chamber 316. The handle 318 includes a handle lumen (not shown) fluidly connected to the chamber 316 through the secondary opening of the housing 312.

One or more portions of the implanted port 310 incorporate contrast 317 for in vivo (in vivo) localization of the puncture membrane 314 of the implanted port 310 by optoelectronic excitation and detection of the contrast 317 using IPDD 500. The puncture membrane 314 of the implanted port 310 may be coupled with a contrast agent 317, as shown in fig. 3B. The palpation bumps (three palpation bumps protruding from the puncture membrane 314 are shown in fig. 3B and 3C) may be combined with a contrast agent 317. The housing 312 of the implantable port 310 may incorporate contrast 317 at least around the main opening of the housing 312, as shown in fig. 3C. The implantable port 310 including the contrast agent 317 is stable to conditions associated with autoclave-based sterilization at temperatures up to at least 60 ℃.

The contrast agent 317 may include nanoparticles, quantum dots, one or more fluorescent dyes, combinations thereof (e.g., fluorescently labeled nanoparticles), or mixtures thereof (e.g., a mixture of nanoparticles and fluorescent dyes). For example, the contrast agent 317 may include nanoparticles. The nanoparticles may be of the type comprising up-converting nanoparticles comprising a lanthanide or actinide doped transition metal. The nanoparticles may be of the type comprising core-shell nanoparticles comprising an organic or inorganic core at least partially encapsulated by at least one separate organic or inorganic shell. The nanoparticles may be of the type comprising gold nanoparticles or silver nanoparticles.

The contrast agent 317 may be configured to absorb incident light having one or more wavelengths within the NIR wavelength range and emit fluorescent light having one or more of the same or different wavelengths within the NIR wavelength range. The NIR wavelength range may be from about 650nm to about 1350nm, which is the optical window of biological tissue in which light in the aforementioned wavelength range penetrates deeper into biological tissue than light outside the aforementioned wavelength range. (see optical window of biological tissue shown in FIG. 7.)

Due to the various shapes, sizes, or capping ligands of the nanoparticles, the nanoparticles may be configured to absorb incident light and emit fluorescence light by surface plasmon resonance in an optical window of the biological tissue. Depending on the desired absorption of incident light and fluorescence emission in the optical window of the biological tissue, a mixture of two or more different types of nanoparticles (e.g., upconverting nanoparticles, core-shell nanoparticles, gold nanoparticles, silver nanoparticles) can be used to achieve the desired absorption of incident light and fluorescence emission in the optical window of the biological tissue. Alternatively, a mixture of two or more nanoparticles of the same type but with different shapes, sizes, or capping ligands may be used to achieve the desired incident light absorption and fluorescence emission in the optical window of the biological tissue.

The nanoparticles can have various shapes, for example, at least the gold nanoparticles can be gold nanospheres, gold nanorods, gold nanostars, or gold nanocups. The nanoparticles can be of various sizes, for example, at least the gold nanospheres can be 4nm, 7nm, 15nm, 30nm, 45nm, 60nm, 80nm, 100nm, 150nm, or 200nm in diameter. The peak absorption of each size of the aforementioned gold nanospheres is between 520nm and 850nm (e.g., between 520nm and 580nm for 15 to 100nm gold nanospheres), and generally follows the trend of the larger the diameter, the longer the wavelength of light absorbed at the peak absorption. That is, the larger the diameter, the wider the peak absorption until the absorbance of the bulk metal (e.g., bulk gold in the case of gold nanoparticles) is reached. (see absorption spectrum of the aforementioned gold nanospheres shown in fig. 4A.) the gold nanorods may have a length of 29.2nm and a diameter of 7.5nm, a length of 30.7nm and a diameter of 8.8nm, a length of 37.9nm and a diameter of 13.8nm, or a length of 52.6nm and a diameter of 23.9nm, and an aspect ratio of 3.9, 3.5, 2.8, or 2.2. The peak absorption of each size of the aforementioned gold nanorods is between 570nm and 760 nm. (see absorption spectrum of the aforementioned gold nanospheres shown in FIG. 4B.)

With respect to capping ligands, for example, at least the gold nanospheres or gold nanorods can include capping ligands derived from biotin, methoxypolyethylene glycol, or citric acid.

Implanted transfusion port detection device

Fig. 5 illustrates an IPDD 500 according to some embodiments. Fig. 6 illustrates modules of an IPDD 500 according to some embodiments.

As shown, in some embodiments, IPDD 500 comprises a body 510 (e.g., a molded plastic body), body 510 comprising a handle 512 and a display 520 disposed within body 510, thereby providing a handheld device. When the IPDD 500 is powered on, the display 520 is configured to provide a graphical user interface ("GUI") 222 (see fig. 2), which GUI 222 is in turn configured to display the presence of the implanted port 310 when the light detector 644 detects fluorescence from the contrast agent 317. Within at least a portion of the main body 510, the IPDD 500 further comprises a microcontroller 630, a light sensor module 540 and a power system 250, the microcontroller 630 configured at least for operation of the IPDD 500 including image processing using an image processing algorithm, the power system 250 (see fig. 2) comprising a battery 252 (see fig. 2), the battery 252 being chargeable via an AC/DC converter 654, the AC/DC converter 654 configured to convert AC power (e.g., universal AC power) from a power supply 656 to DC power for charging the battery 252.

The light sensor module 540 includes a light source 642, a light detector 644 (e.g., a CCD sensor), and optionally, one or more optical filters 646.

The light source 642 may be one or more lasers, LEDs, or a combination thereof configured to emit light having one or more wavelengths in the NIR wavelength range (e.g., 660nm, 780nm, 830nm, 850nm, or 860nm) as incident light hv_iIncident light hv_iFor absorption by the contrast agent 317 incorporated into one or more portions of the implanted port 310. The incident light may haveOne or more wavelengths at or near the peak absorption of the contrast agent 317. When the contrast agent comprises gold nanoparticles (e.g., gold nanospheres, gold nanorods, etc.), incident light at or near the peak absorption is believed to cause surface plasmon resonance, which in turn is believed to provide fluorescent hv_i。

The light detector 644 is configured to detect light having one or more of the same or different wavelengths in the NIR wavelength range, including fluorescence emitted by the contrast agent 317 after the incident light is absorbed by the contrast agent 317. The light detector 644 may be a NIR sensitive camera configured to capture images or video of at least a portion of the environment (e.g., the body surface of the patient P) along with the fluorescence of the contrast agent 317 from the implanted infusion port 310 when fluorescence is present. The display 520 may be configured to display an image or video, thereby providing for the presence of the implanted infusion port 310 and its puncture membrane 314.

Because both the incident light from the light source 642 and the fluorescence emitted by the contrast agent 317 may be scattered by light-tissue interactions, the imaging algorithm may be configured to automatically identify so-called hot spots corresponding to one or more wavelengths of fluorescence emitted by the contrast agent 317 of the implanted port 310, for example, using a peak contrast detector. If contrast agent 317 is incorporated in the puncture membrane 314, the imaging algorithm may be configured to identify the luminescent disc as a hot spot. If contrast agent 317 is incorporated in the three palpation bumps protruding from the puncture membrane 314, the imaging algorithm may be configured to identify the three light emitting points as hot spots. If contrast 317 is incorporated in housing 312 around puncture membrane 314, the imaging algorithm may be configured to identify the light emitting ring as a hot spot. When the light detector 644 is a NIR sensitive camera, hotspots may be identified by graphical elements in the GUI 222 when displaying images or video from the NIR sensitive camera (if not immediately identifiable in the image or video).

Alternatively or in addition to identifying a hot spot on an image or video from the NIR sensitive camera with a graphical element in the GUI 222 corresponding to the puncture membrane 314 of the implantable port 310, a laser may be used to identify the hot spot. The laser may be a laser of the one or more lasers of light source 642 of IPDD 500. If the laser is the same as the laser used by any of the one or more lasers of the light source 642, the laser may be configured to flash alternately between at least two different wavelengths when a hot spot is identified. A first wavelength in the NIR wavelength range may be flashed for continued excitation of the contrast agent 317 and a second wavelength in the visible wavelength range may be flashed for visual identification of hot spots on the patient P. If the laser is different from the laser used by any of the one or more lasers of the light source 642, the laser may be configured to fixedly illuminate the hot spot in the visible wavelength range for visually identifying the hot spot on the patient P. The laser may also be configured to automatically point and track a hot spot on the patient P when using the IPDD 500. In this way, when the puncture membrane 314 of the implanted port 310 is identified, the laser providing visual identification of the hot spot on the patient P may be turned "on". Otherwise, the laser is turned off, thereby providing the clinician with an easy mechanism to identify the pierced membrane 314 of the implanted infusion port 310.

If one or more filters 646 are used, the one or more filters 646 may overlie an aperture of the photodetector 644, such as an aperture of a NIR sensitive camera, to cut off wavelengths of interfering light. In other words, one or more optical filters 646 may be located between the photodetector 644 and the patient P. Thus, light from portions of the environment (e.g., a body surface of a patient), including fluorescence from the contrast agent 317 of the implanted port 310, may be filtered by one or more filters 646 to produce filtered light hv_fThereby cutting off the wavelength of the interfering light that passes to the photodetector 644. When the light detector 644 is a NIR sensitive camera, cutting off the wavelength of the interfering light improves contrast in the generated image or video. At least one of the one or more filters 646 may be a dichroic filter configured to cut bandpass filters or long pass filters of wavelengths shorter than about 600nm (i.e., both the ultraviolet and visible portions of the electromagnetic spectrum with wavelengths greater than about 600 nm). (see the transmission curve for such an optical filter shown in fig. 7.)

Method

In some embodiments, a method for an implantable port detection system 100 comprises: emitting light from a light source 642 of the IPDD 500 as incident light, detecting light with a light detector 644 of the IPDD 500, the light including fluorescence from the implanted port 310 implanted in the patient P, and indicating the presence of the implanted port 310 in the patient P. The incident light emitted from light source 642 of IPDD 500 has one or more wavelengths in the NIR wavelength range. The fluorescence from the implanted port 310 is the fluorescence emitted by the contrast agent 317 after the incident light is absorbed by the contrast agent 317 incorporated in the implanted port 310. The fluorescence has one or more of the same or different wavelengths in the near infrared wavelength range. When the light detector 644 detects fluorescence from the contrast agent 317, the presence of the port 310 implanted in the patient P is indicated.

The light detector 644 may be a NIR sensitive camera, and the method may further include capturing an image or video. Displaying the presence of the implanted port 310 implanted in the patient P includes displaying an image or video of at least a portion of the body surface of the patient P along with fluorescence emitted by the contrast media 317 incorporated in the implanted port 310 when fluorescence is present.

The method may further comprise piercing a puncture membrane 314 of the implantable port 310 with a centerless needle to collect a blood sample from a chamber 316 of the implantable port 310 or to deliver a therapeutic agent to the chamber 316 of the implantable port 310. In addition, the method may further include removing the implanted port 310 implanted in the patient P.

Fig. 8 illustrates another method 800 for an implanted port detection system 100 according to some embodiments.

As shown, operation 810 includes powering on the IPDD 500 and holding the IPDD 500 in the dominant hand. Operation 820 comprises aiming the sensor module 540 of the IPDD 500 at the approximate location of the port implanted in the patient P. Operation 830 comprises IPDD 500 indicating the exact location of the implanted port including its puncture membrane 314 within the patient P. Operation 840 includes disinfecting the patient P in an area around the exact location of the implanted port using the non-dominant hand. Operation 850 includes setting aside materials for disinfecting the patient P. Operation 860 includes stabilizing the implanted access port with the non-dominant hand. Operation 870 includes setting IPDD 500 aside and preparing a pin or some other access device for access. Operation 880 includes accessing the implanted access port with a dominant hand using a needle or other access device.

Although some specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in detail, the specific embodiments are not intended to limit the scope of the concepts presented herein. Additional adaptations and/or modifications may occur to those skilled in the art and are intended to be included in the broader aspects. Accordingly, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.