Patent Application
20240057889
The present disclosure relates generally to medical implant components useful for determining the location and/or orientation of the medical implant inside a subject, e.g., a patient. For example, the present disclosure includes port assemblies detectable with an external reader. The port assembly may be configured as an injection port for a medical implant including a tissue expander. Related methods of use of the port assemblies and medical implants are also described.
Implantable medical devices may be implanted into patients for a variety of reasons, including, for example, to improve the clinical condition of a patient or to replace natural patient tissue. Injection ports of tissue expanders provide access to tissue expanders while implanted within a patient. Electromagnetic signals may be used to provide information on the location of an injection port of the tissue expander to facilitate access to the port. When a tissue expander is in an irregular position, such as when a tissue expander has flipped position, the injection port may be inaccessible to a physician or other medical professional, who could inadvertently puncture the tissue expander in an effort to access the injection port.
The present disclosure includes port assemblies useful for providing access to a medical implant and/or determining the location and/or orientation of the implant inside a patient. Included herein are injection ports for tissue expanders comprising features that may provide for increased safety and/or decreased necessity for invasive procedures. While portions of this disclosure refer to tissue expanders and breast implants, the devices and methods disclosed herein may be used with other implantable medical devices, such as, e.g., other implants used in cosmetic and/or reconstruction procedures. Thus, for example, the port assemblies herein may provide distinctive signature(s) via electronic signal(s) and/or image(s) to assist a medical professional to determine the location and orientation of a medical implant in a non-invasive manner. The port assemblies herein may provide for introduction and/or removal of a fluid from the implant (e.g., an injection port of a tissue expander) but are not limited to fluid injection capability.
The present disclosure includes an integrated port (also referred to herein as a port or port assembly) comprising a housing comprising a first portion coupled to a second portion, wherein the first portion and the second portion comprise different materials; and a cover (e.g., a dome) over an opening into the housing; wherein the first portion faces the cover and allows transmission of electromagnetic signals through the first portion, the first portion being between the second portion and the cover; and wherein the second portion prevents transmission of electromagnetic signals through the second portion in a direction away from the cover. In some aspects, the integrated port further comprises an electromagnetic coil between the first portion and the second portion of the housing. Each of the first portion of the housing and the cover may comprise a polymer, e.g., the same polymer or different polymers. Additionally or alternatively, the second portion of the housing may comprise a non-ferromagnetic metal or non-ferromagnetic metal alloy. In at least one example, the second portion of the housing comprises aluminum. In some examples, the integrated port does not comprise any ferromagnetic materials.
In at least one example, the housing forms a chamber configured to receive a fluid, the chamber comprising the first portion and a second portion; and the integrated port comprises a coil between the first portion and the second portion. The first portion may be configured as a needle stop. The first portion may allow transmission of electromagnetic signals from the coil while the second portion prevents transmission of electromagnetic signals from the coil. As mentioned above, the first portion may comprise a polymer and/or the second portion may comprise a non-ferromagnetic metal or non-ferromagnetic metal alloy. For example, the second portion may comprise aluminum and/or the first portion may comprise a polymer such as poly-ether-ether-ketone. Optionally, the cover may be self-sealing, e.g., when an injection device such as a needle punctures the cover for introducing or removing fluid from the integrated port. The coil may be contained within a fluid-tight compartment of the housing that prevents contact between the coil and a fluid within the chamber. As mentioned above, in some examples, the integrated port does not comprise any ferromagnetic materials. In at least one example, the housing is cylindrical in shape.
The present disclosure also includes medical implants comprising the integrated ports herein. For example, the implant may comprise a flexible shell, and the cover (e.g., dome) of the integrated port may be coupled to an inner surface or an outer surface of the shell. For example, the cover may be coupled to the shell with an adhesive. In at least one example, the shell of the implant comprises silicone, and the cover of the integrated port comprises silicone or poly-ether-ether-ketone. In some aspects, the medical implant may be a tissue expander.
The present disclosure also includes methods of locating the integrated ports herein, e.g., providing information about the position, location, and/or orientation of a medical implant that includes an integrated port as disclosed herein. The method may include ultrasound imaging and analyzing echoes from the integrated port and/or analyzing a presence or absence of RFID signals from the integrated port to determine an orientation of the implant relative to tissue of a patient.
Further disclosed herein is an integrated port comprising a chamber configured to receive a fluid, the chamber comprising a first portion and a second portion, wherein the first portion comprises a material different from a material of the second portion, one of the materials being a non-ferromagnetic metal; a coil between the first portion and the second portion; and a cover (e.g., a dome) covering an opening into the chamber; wherein the first portion faces the dome, the first portion being configured as a needle stop; and wherein the first portion allows transmission of electromagnetic signals from the coil while the second portion prevents transmission of electromagnetic signals from the coil. In some examples, the integrated port further comprises an integrated circuit chip coupled to the coil, for example soldered to the coil. Medical implants comprising such integrated ports may comprise a flexible shell, e.g., the cover of the integrated port being coupled to an inner surface or an outer surface of the shell.
The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate various examples and together with the description, serve to explain the principles of the present disclosure. Any features of an embodiment or example described herein (e.g., device, method, etc.) may be combined with any other embodiment or example, and are encompassed by the present disclosure.
Aspects of the present disclosure are described in greater detail below. The terms and definitions as used and clarified herein are intended to represent the meaning within the present disclosure. The terms and definitions provided herein control, if in conflict with terms and/or definitions incorporated by reference.
The singular forms “a,” “an,” and “the” include plural reference unless the context dictates otherwise. The terms “approximately” and “about” refer to being nearly the same as a referenced number or value. As used herein, the terms “approximately” and “about” generally should be understood to encompass±5% of a specified amount or value.
As used herein, the term “posterior” refers to the back of a patient, and the term “anterior” refers to front of a patient. Thus, the posterior side of an implant such as a tissue expander or breast implant is the side of the implant facing the chest wall, while the anterior side is the opposite side closest to the skin.
The present disclosure generally relates to medical implants, features of medical implants, port assemblies useful for medical implants, and transponders and sensors for use with such implants and port assemblies, and methods of using such port assemblies, transponders, sensors, and implants. Aspects of the present disclosure may be useful for locating medical devices that may be implanted in the patient. Such implantable medical devices may include, but are not limited to, tissue expanders, breast implants, gluteal implants, and other medical devices in the field of aesthetic or reconstructive surgery, as well as other types of medical devices configured for temporary or permanent implantation inside a patient. Various aspects of the present disclosure may be used with and/or include one or more features of transponders, valve assemblies, integrated ports, and readers disclosed in U.S. Pat. No. 10,176,412, incorporated by reference herein in its entirety.
In some aspects of the present disclosure, the medical implant is a tissue expander. Tissue expanders of the present disclosure may be inflated manually and/or electronically, e.g., with a syringe or other suitable device for introducing and withdrawing a fluid (e.g., a liquid or gaseous fluid) or gel into the tissue expanders. Tissue expanders and other medical implants according to the present disclosure may comprise a port having components useful for determining the location and/or orientation of the tissue expander or other medical implant in a patient, e.g., an integrated port. The terms “integrated port” and “port assembly” are used interchangeably herein to describe ports with features that facilitate identifying the location, position, and/or orientation of a medical implant that includes the integrated port or port assembly. The integrated port may include features to facilitate locating and identifying the port, including in cases when the tissue expander or other medical device is misplaced or suspected of being misplaced, in a non-invasive manner.
For example, the integrated port may comprise an electromagnetic coil configured to emit electromagnetic signals, e.g., radio-frequency identification (RFID) signals, and/or ultrasonic signals. Optionally, the coil may be coupled to an integrated circuit chip and/or other electronic components, including sensors configured to assure medical device integrity such as rupture detection and/or measure patient vitals and/or parameters such as temperature, pressure, heart rate, respiratory rate, and/or pH, among others.
The integrated ports herein may provide or non-invasive methods of detecting if a medical implant, such as a tissue expander, implanted in a patient has been misplaced (e.g., flipped such that the port is in a posterior position towards the patient's chest rather than an anterior position towards the skin surface) and thus whether an additional medical procedure should be performed to reposition the tissue expander. For example, the methods herein may prevent or reduce the risk of inadvertently puncturing a tissue expander or other medical implant, creating a deflation and/or resulting in other complications for the patient. The present disclosure also includes methods of locating the port of a medical implant (e.g., a tissue expander, breast implant, gluteal implant, etc.) via ultrasound imaging, including locating the port independent of RFID location.
One or more portions of the integrated port (or port assembly) may comprise one or more non-ferromagnetic materials. Exemplary non-ferromagnetic materials include, but are not limited to, polymers such as poly-ether-ether-ketone (PEEK), polycarbonate, and other plastics; ceramic; silica (e.g., glass); and non-ferromagnetic metals such as aluminum and copper, and alloys of these metals, as well as other metals and metal alloys that are non-ferromagnetic. In some examples, the integrated port may comprise nickel. For example, the integrated port (or port assembly) may comprise one or more materials, all of which may be non-ferromagnetic, to maintain magnetic resonance imaging (MRI) compatibility. The structure of the integrated port and combination of materials may provide for distinctive signals and/or images to assist a medical professional in determining the location, position, and/or orientation of the medical implant via an external reader and/or imaging.
The integrated port may comprise at least two different materials. For example, the integrated port may comprise two different metals or metal alloys, a polymer and a metal or metal alloy, or two different polymers, among other combinations of materials. In at least one example, the integrated port comprises a polymer, such as PEEK, and an additional material that has capabilities of RFID blocking, such as aluminum. See, e.g.,
In the case of an injection port for a tissue expander, for example, the integrated port may include an electromagnetic coil proximate a needle stop. In at least one example, the RFID-blocking material may be placed adjacent to or on the bottom of a needle stop of the integrated port, or as a “coin” within the needle stop. The coil that emits an RFID signal to assist in locating the integrated port may be proximate, e.g., sit on top of, this RFID-blocking material. Accordingly, the RFID signal may only be detected by a suitable reader/port locator if the RFID-blocking material is not positioned between the coil and the reader/port locator. If the tissue expander has flipped such that the RFID blocking material is between the coil and the reader/port locator, signals emitted from the integrated port may be blocked from detection by the reader/port locator. Failure to detect the integrated port via the port locator may turn on an indicator light of the port locator, e.g., to indicate that the tissue expander is incorrectly positioned, such as due to having flipped or otherwise becoming misplaced.
In some examples, port location may be performed via ultrasound imaging. For example, a difference in materials included in the integrated port may allow for the ultrasound echo to differ. The materials may have different densities, chemical compositions, and/or structure, for example, that provide different signatures via ultrasound imaging. This difference in materials may allow a medical professional to analyze ultrasound images of a patient to determine the location, position, and/or orientation of a medical implant in a non-invasive manner.
Ultrasound, also referred to as sonography, is a non-invasive medical imaging technique useful for observing the environment surrounding a medical implant. Ultrasound can be used to capture internal images of the body, such as muscles, organs, blood vessels, and other tissue, in addition to implants. An ultrasound machine typically includes a transducer and a processor, such as a central processing unit of a computer, connected to a display, such as a monitor. To collect images, the transducer may be placed on a patient's skin and passed over an area of the body to be imaged, wherein sound waves are emitted from the transducer. When a medical professional obtains images using an ultrasound system, the transducer sends a sound wave with an amplitude that changes due to reflection and transmissions as the sound wave contacts different types of anatomical structure. Reflection and transmission coefficients of the sound waves may be used to describe the environment around an implant. The frequency of the sound waves is typically above 20 kHz, e.g., frequencies ranging between 1 MHz and 10 MHz. The sound waves pass through the body and are at least partially reflected back to the transducer after they bounce off relatively more dense structures, such as bodily tissue or an implant. Echo lines in an ultrasound image are a sign of inhomogeneities in an environment. The processor measures the echo intensities and speed of the sound waves, and converts these measurements to electronic images. The ultrasound images provide an indication of anatomy, e.g., wherein brighter areas correspond to features with greater density. As a sound wave has an initial amplitude that undergoes reflections and transmissions depending on the patient's anatomy and medical implants therein, the reflection and transmission characteristics may be analyzed to calculate describe characteristics of medical implants, including location, position, and/or orientation information.
Ultrasound imaging may be used in addition to, or in place of, electromagnetic detection such as RFID detection. In the case of an integrated port comprising silicone and a polymer (e.g., PEEK), for example, ultrasound may be used to visualize the integrated port independent of RFID detection. This feature may provide detection capabilities for medical implants that do not have an electromagnetic coil. For example, a tissue expander may include an integrated port in the form of an injection port comprising two different materials (e.g., PEEK and silicone, or other combination of different materials) that allow for determining the location, position, and/or orientation of the port via non-invasive ultrasound imaging, independent of locating the integrated port via RFID signal.
Reference is made to the following figures as examples of the present disclosure, but it is understood that the present disclosure is limited to the particular structures and examples illustrated.
Dome 620 may have a patch 622, which may have a wider width than plug 621 and valve assembly 610, and may be integral with plug 621. A flange 626 between patch 622 and plug 621 may be configured to accommodate and interlock with lip 619 of valve assembly 610. In this example, dome 620 is illustrated with a step 624 that may be configured to interface with a wall of an implant (e.g., the shell of a tissue expander, breast implant, or other medical implant) into which the integrated port 600 may be installed, e.g., the dome 620 being located radially outside the implant wall and the main chamber 612 being radially inside the implant wall. This is illustrated in
In some examples, the dome 620 may be coupled to the inner surface of a wall of an implant in use, e.g., via an adhesive or other fixation mechanism or material. In such examples, the entire port 600 would be radially inward of the implant wall (e.g., the shell of a tissue expander, breast implant, or other medical implant). In such cases, the port 600 may lack a step 624. For example, the step 624 in
Valve assembly 610 may comprise biocompatible, non-ferromagnetic material(s), such as PEEK, silicone, and/or other polymer(s), and/or one or more RFID blocking materials such as aluminum, nickel, copper, and/or alloys thereof. Main chamber 612 may be sized, shaped, and configured to receive fluids from, e.g., a cannula, syringe, or other fluid deposition device. Needle stop 617 of main chamber 612 may be configured to prevent or resist puncturing by such a fluid deposition device (e.g., a needle of a syringe). For example, needle stop 617 may comprise one or more materials having a density, hardness, and/or thickness configured to prevent or resist puncturing by a needle. According to some aspects of the present disclosure, integrated port 600 may include a needle stop 617 that comprises a polymer such as PEEK and an RFID-blocking material such as aluminum opposite the needle stop 617.
Coil 616 may be an electromagnetic coil positioned within a separate chamber, e.g., provided in this example by housing 614. Housing 614 may be fluid-tight so as to prevent fluids from entering housing 614 and coming into contact with coil 616. Housing may be cylindrical, as shown, and may be coaxial with main chamber 612, such that coil 616 is also coaxial with main chamber 612. In this manner, the location of coil 616 may be used to locate the center, or the approximate center, of main chamber 612 and housing 614. Housing 614 is depicted as having a smaller circumference than, e.g. main chamber 612. However, in some examples, housing 614 may have dimensions as large or nearly as large as main chamber 612. Coil 616 optionally may be coupled to a chip, e.g., an integrated circuit chip as mentioned above. For example, the chip may be soldered or otherwise in electronic contact with the inner or outer surface of coil 616. Plug 621 of dome 620 may be sized and shaped to snugly interlock with, e.g., lip 619 of main chamber 612. Dome 620 may comprise a biocompatible material such as silicone with self-sealing capabilities.
Second portion 715 may comprise a RFID blocking material, such as aluminum or other suitable metal or metal alloy (which additionally may be non-ferromagnetic for MRI compatibility). The second portion 715 is positioned so as to block RFID transmission from the coil below the needle stop in the direction opposite first portion 710. For example, in the case of a tissue expander or other medical implant, second portion 715 may face the posterior side of the tissue expander or other medical implant, while the first portion 710 faces the anterior side of the tissue expander or other medical implant. This configuration is further illustrated in the example shown in
Additionally, as mentioned above, the integrated ports herein may provide for ultrasound imaging for determining whether the medical implant, e.g., tissue expander, breast implant, gluteal implant, etc., is properly placed, e.g., so as to access the integrated port. A difference in materials of the components of the port, such as different materials used for a needle stop component (e.g., first and second portions 710, 715 above) may allow for an ultrasound echo or echoes to determine the location, position, and/or orientation of the integrated port.
According to some aspects of the present disclosure, the inner housing 314 and the walled structure 315 may comprise different materials, one of inner housing 314 or walled structure 315 comprising a material that allows transmission of RFID signals and the other of inner housing 314 or walled structure 315 comprising an RFID-blocking material such as aluminum or other suitable metal or metal alloy, including other non-ferromagnetic metals and metal alloys. Thus, for example, RFID signals emitted by the coil 316 may pass through the inner housing 314 for detection via an external reader or port locator external to a patient, while RFID are blocked from passing through walled structure 315. In this way, a user of the reader or port locator would have information regarding the position, location, and/or orientation of the port assembly 300 to determine if the implant has the proper position, location, and orientation in a patient. A medical professional additionally or alternatively may use ultrasound imaging to determine the position, location, and/or orientation of the port assembly 300, e.g., due to differences in ultrasound echoes of the different materials of inner housing 314 and walled structure 315.
According to some aspects of the present disclosure, the inner housing 450 and the walled structure 460 and/or plate 470 may comprise different materials. For example, one of inner housing 450 or walled structure 460 may comprise a material that allows transmission of RFID signals and the other of inner housing 450 or walled structure 460 may comprise an RFID-blocking material such as aluminum or other suitable metal or metal alloy, including other non-ferromagnetic metals and metal alloys. Additionally or alternatively, one of inner housing 450 or plate 470 may comprise a material that allows transmission of RFID signals and the other of inner housing 450 or plate 470 may comprise an RFID-blocking material such as aluminum or other suitable metal or metal alloy, including other non-ferromagnetic metals and metal alloys. In some examples, the walled structure 460 and the plate 470 may both comprise an RFID blocking material while the inner housing 450 comprises a material that permits transmission of RFID signals therethrough, e.g., a polymer such as PEEK. Thus, for example, RFID signals emitted by the coil 416 (disposed between the inner housing 450 and the plate 470) may pass through the inner housing 450 for detection via an external reader or port locator external to a patient, while RFID are blocked from passing through plate 470 and walled structure 460. A user of the reader or port locator would have information regarding the position, location, and/or orientation of the port assembly 400 to determine if the implant has the proper position, location, and orientation in a patient. A medical professional additionally or alternatively may use ultrasound imaging to determine the position, location, and/or orientation of the port assembly 400, e.g., due to differences in ultrasound echoes of the different materials of inner housing 450, walled structure 460, and/or plate 470.
While principles of the disclosure are described herein with reference to illustrative aspects for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, aspects, and substitution of equivalents all fall within the scope of the aspects described herein. Accordingly, the disclosure is not to be considered as limited by the foregoing description.
Other exemplary embodiments of this disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the exemplary embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, and departures in form and detail may be made without departing from the scope and spirit of this disclosure as defined by the following claims.
This application claims priority to U.S. Provisional Application No. 63/134,858 filed on Jan. 7, 2021, which is incorporated by reference herein in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2022/050090 | 1/6/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63134858 | Jan 2021 | US |
