WO2022126124A1 - Compositions de marquage radio-opaques et leur utilisation - Google Patents

Compositions de marquage radio-opaques et leur utilisation Download PDF

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Publication number
WO2022126124A1
WO2022126124A1 PCT/US2021/072842 US2021072842W WO2022126124A1 WO 2022126124 A1 WO2022126124 A1 WO 2022126124A1 US 2021072842 W US2021072842 W US 2021072842W WO 2022126124 A1 WO2022126124 A1 WO 2022126124A1
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WO
WIPO (PCT)
Prior art keywords
radiopaque
polymer
topical
silicone
substance
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Application number
PCT/US2021/072842
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English (en)
Inventor
Joseph Passman
Donovan Prewett
Original Assignee
Joseph Passman
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
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Publication of WO2022126124A1 publication Critical patent/WO2022126124A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/245—Bismuth; Compounds thereof

Definitions

  • This disclosure relates to radiopaque marking mediums that are also visible in normal light, and particularly to topical radiopaque marking substances and delivery mechanisms therefor.
  • Topical radiopaque markings are used to delineate anatomical locations in a variety of clinical settings and scenarios.
  • image-guided surgery topical markings are used to provide a precise correlation between the patient and their scanned images. Examples include the following:
  • diagnostic imaging topical markings are used to define anatomical locations and to orient the interpreting clinician.
  • cardiovascular surgery topical markings are used to define vascular access sites, to size anatomic organs, to define implant location, and to size implants.
  • topical markings may be used to specifically guide amputation location.
  • topical markings are used to guide procedures like CT-guided lung biopsy.
  • Bone screws - marking skin entry site Biliary intervention - triangulating anatomy
  • Ablation - uses picture of stick area, line up with laser, prep over (chlorohexidine), then puncture through x-marks
  • Chest tube placement - targeting with CT and making mark with CT and go through with x-ray G-tube placement - mark colon on scan as a reference point to avoid
  • Nephrostomy tube placement - mark relevant structures to avoid Fistula de-clotting; Stent placement; and, Bone/wire fixation in plastic surgery.
  • U.S. Patent No. 9,861 ,449 entitled Radiopaque Marking Implant discloses a crayon-like marker that applies a topical marking. However, the marking is prone to smearing and is not easily and/or cleanly removed from a patient’s skin.
  • U.S. Patent No. 10,709,800 entitled Radiopaque Writing Instruments and Methods of Use discloses a liquid marker used to apply a topical marking. However, the marking is prone to smearing, does not apply evenly, dries too slowly and is not easily removed from the patient’s skin.
  • compositions and devices for marking a patient's skin or a covering thereon include compositions and devices for marking a patient's skin or a covering thereon.
  • a marking composition according to this disclosure which may also be referred to as an “ink,” may provide a mark that is visible to an individual when viewed directly and in images obtained from one or more common imaging modalities (e.g., x-ray, fluoroscopy, CT, etc.).
  • the marking composition may be formulated to enable a clinician to mark a patient's skin clearly and accurately to provide a well-defined and unambiguous marking that contrasts with the surface to which it is applied and that indicates the identity of the patient, the site (e.g., surgical location, etc.) where the patient is to be treated, and/or the procedure, or treatment approach, to be taken, including any patient-specific details of the procedure.
  • the marking composition of the present disclosure may be formulated by two components, each of which being composed by at least 50% radiopaque agent in order to provide adequate visibility under radiologic imaging. Lower concentrations of radiopaque agent may be used for more viscous formulations that apply more thickly; however, this increase in viscosity leads to undesirable delivery properties.
  • the radiopaque agent may itself be composed of multiple radiopaque agents. [0014] In one embodiment the two components are each composed of around 53.6% radiopaque agent. In one embodiment the two components are each composed of around 54% radiopaque agent.
  • the composition of the at least two components should be a minimum of 50% radiopaque agent.
  • the applied layer thickness is preferred to be less than 1.5mm.
  • the components need not each be composed of at least 50% radiopaque agent as long as the composite marking composition, comprised of the two components, of the present disclosure itself is composed of at least 50% radiopaque agent.
  • the two components could each be composed of 25% radiopaque agent and 75% radiopaque agent, respectively, such that, when combined, the composite marking composition is at least 50% radiopaque agent.
  • the two components may be comprised of a silicone base.
  • the two components are further comprised of a silicone polymer that includes silica, either particulate silica or fumed silica.
  • a topical radiopaque marking composition of the present disclosure may include a first radiopaque polymer component comprising a silicone polymer and a radiopaque agent, the radiopaque agent making up at least 50% of the first radiopaque polymer component; and a second radiopaque polymer component comprising a silicone polymer and a radiopaque agent, the radiopaque agent making up at least 50% of the second radiopaque polymer component; wherein the first radiopaque polymer component and said second radiopaque polymer component are mixable to form one topical radiopaque marking substance.
  • a method of applying a topical radiopaque marking substance of the present disclosure may include providing a radiopaque polymer A and a radiopaque polymer B, each of which having a radiopaque agent content of at least 50% and then mixing the radiopaque polymer A and radiopaque polymer B to form the topical radiopaque marking substance; and performing the mixing just prior to applying the topical radiopaque marking substance to a target site.
  • a method of making a topical radiopaque marking substance of the present disclosure may include providing a silicone base; formulating a silicone polymer A and a silicone polymer B from the silicone base wherein the composition of silicone polymer A is different than the composition of silicone polymer A; adding at least one radiopaque substance to each of silicone polymer A and silicone polymer B to form a radiopaque polymer A and a radiopaque polymer B, respectively; and, mixing radiopaque polymer A and radiopaque polymer B to form the topical radiopaque marking substance.
  • a method of making a topical radiopaque marking substance of the present disclosure may include providing a silicone base; formulating a silicone polymer from said silicone base; adding at least one radiopaque substance to the silicone polymer to form a radiopaque base; formulating a radiopaque polymer A and a radiopaque polymer B from the radiopaque base, wherein the composition of radiopaque polymer A is different from the composition of radiopaque polymer B; and mixing radiopaque polymer A and radiopaque polymer B to form the topical radiopaque marking substance.
  • a device for delivering a topical radiopaque marking substance in accordance with the present disclosure may include dual chambers disposed in the housing, one chamber containing a silicone based radiopaque polymer A and one chamber containing a silicone based radiopaque polymer B; a mixer disposed at a distal end of the housing; a dual chamber plunger interoperative with the dual chamber; a spring for urging movement of the dual chamber plunger into said dual chamber; and a push button to actuate movement of the dual chamber plunger.
  • FIG. 1 is two photographs, both of the same hand with a topical radiopaque composition in accordance with the present disclosure, one photograph in normal light and one photograph under radiologic imaging;
  • Fig. 2 is a photograph of an animal with a topical radiopaque composition in accordance with the present disclosure when viewed in normal light;
  • Fig. 3 is a photograph of the animal of Fig. 2 when viewed under fluoroscopic radiologic imaging
  • Fig. 4 is series of photographs of a topical radiopaque composition in accordance with the present disclosure, one under normal light and two under computed tomography (CT) imaging;
  • CT computed tomography
  • Fig. 5 is a photograph of a topical radiopaque composition in accordance with the present disclosure being removed from the skin of subject;
  • Fig. 6 is a flow chart for a formulation of a topical radiopaque composition in accordance with the present disclosure
  • Fig. 7 is a flow chart for a formulation of a topical radiopaque composition in accordance with the present disclosure
  • Fig. 8 is a cross-sectional schematic view of a mixer and applicator mechanism for a dual component substance in accordance with the present disclosure
  • Fig. 9 is a cross-sectional schematic view of a mixer and applicator mechanism for a dual component substance in accordance with the present disclosure
  • FIG. 10 is a perspective view of a housing usable with a dual component mixer and applicator in accordance with the present disclosure
  • FIGs 11A-11 C are perspective views of a housing usable with a dual component mixer and applicator in accordance with the present disclosure
  • FIG. 12 is a perspective view of a housing usable with a dual component mixer and applicator in accordance with the present disclosure
  • FIGs 13A-13B are perspective views of a housing usable with a dual component mixer and applicator in accordance with the present disclosure.
  • Fig. 14 is a perspective view of a housing usable with a dual component mixer and applicator in accordance with the present disclosure.
  • This disclosure is directed to a topical freeform radiopaque marking composition and a marking mechanism useful in making clear and unambiguous markings on a patient in preparation for medical procedures such as surgeries and other procedures, and particularly in surgeries and procedures that require radiographic imaging (e.g., X-Ray, CT scanning, fluoroscopy, SPECT, MRI, PET-CT, MRA, nuclear medicine scans).
  • the markings may identify the patient, one or more treatment sites on the patient, the procedure(s) to be conducted at each treatment site (e.g., surgical approaches, etc.), one or more anatomic landmarks, the interventional approach or the like.
  • the markings are versatile and helpful both in surgeries and procedures that don’t require the aid of radiographic imaging and those that do.
  • a topical freeform radiopaque marking composition in accordance with this disclosure is shown Figs. 1 -3 in connection with a procedure involving hand surgery (Fig. 1 ) and a procedure involving a vascular operation (Figs. 2-3) where the marking composition is clearly seen both under normal vision and in radiographic imaging.
  • the topical freeform radiopaque marking composition in accordance with this disclosure is useful in CT imaging as shown in Fig. 4.
  • a grid is drawn on a torso phantom in a simulated CT-guided lung biopsy. The far left photos is the composition in normal light and the remaining two photos show the composition in CT images. The marking composition is visible and shows no imaging artifact.
  • the topical freeform radiopaque composition is also easily removable from the skin of a patient as shown in Fig. 5.
  • a topical freeform radiopaque marking composition according to this disclosure has superior properties in its viewing properties under radiographic imaging, in its non-smearing properties, in its ease in removal from a patient’s skin; in its ease in delivery and in its versatility.
  • the topical freeform radiopaque marking composition has a radiopaque agent that makes up at least 50% of the composition. Another reason may be that it is formulated from a silicone base. Another reason may be that its viscosity is in a range of 5000-7500 CPS, preferably 6500 CPS. Another reason may be that its cure time is in a range of 10 seconds to 3 minutes, and preferably 10 seconds to 60 seconds. Another reason may be that it is comprised of two components that polymerize and cross-link when mixed.
  • the topical radiopaque marking composition of the present disclosure need not be formulated from only two components. As will be appreciated by one of skill in the art, more than two components could be used without departing from the scope of this disclosure and still arrive at a topical radiopaque marking composition that has at least 50% radiopaque composition, has a viscosity in a range of 5000-7500 CPS and a cure time in a range of 10 seconds to 3 minutes.
  • the example formulations contained herein are not limiting to the scope of the invention..
  • a topical freeform radiopaque marking composition may comprise two components which, when mixed together, provide a topical freeform radiopaque marking substance.
  • Each component may include one or more radio-opaque components.
  • Each component may include a silicone base.
  • Each component may also include a pigment.
  • Each component may include one or more of the following: a siloxane, a chain extender and a cross-linker.
  • Each component may have a radiopaque agent of over 50%.
  • a topical radiopaque marking composition of the present disclosure is non-limiting examples for a topical radiopaque marking composition of the present disclosure.
  • a radiopaque marking composition that has at least 50% radiopaque agent, a viscosity in a range of 5000-7500 CPS and a cure time in a range of 10 seconds to 3 minutes.
  • radiopaque agents and combinations thereof can differ from those disclosed in the examples and still result in a radiopaque marking composition in accordance with the present disclosure.
  • Topical freeform radiopaque marking substance of the present disclosure may have the formulation set forth below:
  • Example 1 Compared to prior art topical radiopaque marker substances (e.g., those mentioned in the patents identified above), the formulation of Example 1 was found to have improved curing times, negligible smearing, reduced preparation time of the application site (e.g., can use standard preparation like betadine and wipes), and is easily removed from the skin as shown in Fig. 5.
  • the process by which the Radiopaque Polymer A and Radiopaque Polymer B of the chart above may be formed is where a Silicone Base is used to form a Silicone Polymer A and a Silicone Polymer B which, in turn, are used to make Radiopaque Polymer A and Radiopaque Polymer B, respectively.
  • Radiopaque Polymer A and Radiopaque Polymer B are mixed together during ejection from an applicator onto, for example, a patient, in the form of a freeform topical radiopaque marking substance in accordance with this disclosure.
  • the freeform topical radiopaque marker substance of Example 1 may be produced in the following manner:
  • the silicone base is produced by mixing HMDZ treated precipitated silica with 10,000 vinyl siloxane.
  • the silicone base and the vinyl siloxanes (VIN 70 & VIN 200) to be used in producing Silicone Polymer A and Silicone Polymer B (the “Silicone Polymers”) are weighed out in a container.
  • radiopaque agents barium sulfate, sodium diatrizoate, and bismuth III oxide
  • the radiopaque agents barium sulfate, sodium diatrizoate, and bismuth III oxide
  • the viscosity of the mixture should be where it is pourable but once poured the mixture will not drip or run. In one embodiment the viscosity is in a range of 6,500 to 7,200 cps).
  • the mixture is placed under a rotator-stator homogenizer and thoroughly mixed until the radiopaque agents are thoroughly dispersed. Once the mixture is homogenous, the mixture is split into two equal parts, Part A and Part B.
  • White silicone pigment and a 3% platinum catalyst is added to Part A and mixed using a high-speed disperser blade
  • Blue pigment, a chain extender (DH6) and a hydride cross linking agent is added to Part B and mixed using a high-speed disperser blade.
  • the mixing process can take between 6-8 hours to achieve a desired viscosity.
  • Part A and Part B mixtures are placed in a vacuum chamber until there are no visible bubbles.
  • radiopaque polymer A and radiopaque polymer B of Example 1 are mixed when exiting an applicator.
  • the two radiopaque polymers contain different agents that, when mixed, enable polymerization and cross-linking of the vinyl monomers via the formation of a siloxane bond.
  • the resulting freeform topical radiopaque marker substance has a cure time of around 3 minutes and a viscosity of 5000 CPS.
  • the shelf life of radiopaque polymer A and radiopaque polymer B of Example 1 is formulated to be 1 year.
  • the freeform topical radiopaque marking substance may have a formulation as set forth below.
  • Radiopaque Polymer A and Radiopaque Polymer B of the chart above may be formed is where a Silicone Base is used to form a Silicone Polymer which is then used to form a Radiopaque Base.
  • the Radiopaque Base is then used to form a Radiopaque Polymer A and Radiopaque Polymer B, respectively.
  • Radiopaque Polymer A and Radiopaque Polymer B are mixed together during ejection from an applicator onto, for example, a patient, in the form of a freeform topical radiopaque marking substance in accordance with this disclosure.
  • the freeform topical radiopaque marker substance of Example 2 may be produced in the following manner:
  • HMDZ treated fumed silica and 10,000 vinyl siloxane are mixed together to form a silicone base.
  • a quality check may be performed to check viscosity and thixotropic index with expected values being those set forth in Fig. 7
  • the silicone base is then mixed together with 200 vinyl siloxane in a plastic container using a Ross mixer to produce a silicone polymer. In one embodiment, the mixing is performed for 30 min.
  • the viscosity of the silicone polymer after mixing at 2 RPM was 912 cps.
  • the viscosity of the silicone polymer after mixing at 20 RPM was 896 cps.
  • the Thixotropic Index of the silicone polymer was 1.018.
  • a desired amount of silicone polymer is then move to stainless-steel container and fumed silica is added. Further mixing at high-speed using the ROSS mixer is performed.
  • sodium diatrizoate is added.
  • the sodium diatrizoate is added over a period of 10-15 minutes.
  • the resulting radiopaque base is then placed under a rotor/stator mixer and mixed for 15 min.
  • the viscosity may be checked for the expected values as set forth in Fig. 7.
  • the viscosity of the radiopaque base is 6480 cps.
  • the radiopaque base is then placed under vacuum until air is removed.
  • Radiopaque base is then divided into 2 equal parts, a Part A and Part B.
  • White pigment and 3% platinum catalyst are added to Part A while mixing under a ROSS mixer to form radiopaque polymer A.
  • Part B is placed under a ROSS mixer and while mixing at a medium speed, blue silicone pigment is added. Once the blue pigment is thoroughly mixed in (e.g., 10-15 minutes) DH-6 (hydride chain extender) is added.
  • DH-6 hydride chain extender
  • the resulting compound constitutes radiopaque polymer B.
  • the cure time when the radiopaque polymer A and radiopaque polymer B are combined is then measured. In one embodiment, the cure time is less than 15 seconds.
  • the sodium diatrizoate molecule has 3 iodine groups attached which aids in radiopacity.
  • Sodium diatrizoate in an aqueous solution is subject to degradation. Heat and pH effects the stability.
  • 20 grams of Part A and 20 grams of Part B were placed in an oven at 60 C (140 °F) for 8 days. This equals 3 months at ambient temperature (22-25C). There was no material degradation.
  • the radiopaque polymer A and radiopaque polymer B of Example 2 are mixed when exiting an applicator.
  • the two radiopaque polymers contain different agents that, when mixed together, enable polymerization and cross-linking of the vinyl monomers via the formation of a siloxane bond.
  • the resulting topical radiopaque marker substance has a cure time of around 15 seconds and a viscosity of 6500 CPS.
  • the shelf life of radiopaque polymer A and radiopaque polymer B of Example 2 is formulated to be 2 years.
  • Example 2 Compared to prior art topical radiopaque marker substance (e.g., those mentioned in the patents identified above), the formulation of Example 2 was found to have improved curing times, negligible smearing, improved preparation of the application site (e.g., can use standard preparation like betadine and wipes to clean the interventional site; the prior art substances, e.g., those disclosed in the patents identified above, do not allow for preparation because they dissolve and smear when they interact with preparation agents like betadine or alcohol), and is easily removed from the skin without pain and without leaving a residue. In addition, as compared to Examiner 1 , Example 2 shows a faster cure time, increased viscosity, improved visual appearance of the topical marking, and increased shelf stability.
  • a radiopaque polymer A may have a white pigment and a radiopaque polymer B may have a blue pigment wherein the resulting color of the topical radiopaque marker substance has a blue color. It will be appreciated by one of skill in the art that different color pigments are also usable, so long as the color of the resulting topical radiopaque marker substance is visible to a user in normal light.
  • the freeform topical radiopaque marking substance in accordance with this disclosure is applied in a two-part mixing apparatus wherein Part A and Part B of the freeform topical radiopaque marking substance as discussed above is mixed during dispensing of the substance from the applicator to a location on a patient.
  • Prior two-part mixing applicators are known in the art.
  • Examples of such mixers include U.S. Patent No. 10,464,719 entitled Multi-chambered dispenser and process; U.S. Patent No. 7,882,983 entitled Capsule for Two-Component Materials; U.S. Patent No. 10,130,768 entitled Combination Plunger Device for a Dual Chamber Mixing Syringe, each of which is hereby incorporated by reference.
  • Such devices are characterized, at least in part, by the mixing together of two components of a substance. Often, a spring and a plunger are used to urge each component out of its respective chamber and into a mixing area at the dispensing end of the device.
  • FIG. 8 depicts the mechanism in a filled but static state
  • Fig. 9 depicts the mechanism in a dispensing state.
  • the mechanism includes dual chambers, 122 and 124 for holding two components to be mixed, e.g., Radiopaque Polymer A and Radiopaque Polymer B, respectively.
  • a dual chamber plunger 118 seals the dual chambers 122, 124 and also serves as the means by which the components to be mixed are forced out of the mechanism through the mixer 120.
  • a plunger spring 116 is disposed between a rear of the housing 102 and the dual chamber plunger 118.
  • the plunger spring 116 is in a compressed or “pre-loaded” state.
  • the plunger spring 116 is held in the compressed or “pre-loaded” by the push piece 114 of an actuating rod 112.
  • the actuating rod extends from one end where it couples with the dual chamber plunger 118 (via the push piece 114) to its opposite end which sits between a push button 104 and a push button spring 106.
  • the actuator rod 112 also has a series of actuator stop notches 110 which interface with at least one corresponding housing stop notch 108 positioned in the housing 102.
  • the two components have been loaded into the dual chambers 122, 124, respectively.
  • the actuator rod 112 has been situated so as to compress the plunger spring 116 via the push piece 114.
  • the actuator rod 112 is secured in this position via the interface and matching shapes of the actuator stop notches 110 and the corresponding housing stop notch 108.
  • the push button spring 106 is applying force on the front end of the actuator rod 112 so that it pushes the push button 104 away from the surface of the housing 100.
  • each component will be urged through the mixer 120 at the distal end of the mechanism 100.
  • the mixer 120 will mix the two components together and the combined, mixed substance will then exit the mechanism.
  • the components are a Radiopaque Polymer A and a Radiopaque Polymer B which, when mixed by mixer 120, will exit the device as a topical freeform radiopaque marking substance in accordance with this disclosure.
  • the destination of the mixed substance can be a patient’s skin or a surgical drape, for example.
  • FIG. 8 A number of possible housings for receiving a dispensing and mixing mechanism such as the mechanism 100 described in one embodiment above are now described.
  • the interior structure mixing mechanism of these housings are not restricted to the design set forth in Figs. 8 and 9, but, rather, can be any two-component mixing device known to those of skill in the art that can fit or by modified to fit into the housing device, or variations thereof, as depicted herein
  • a housing 200 includes a clip 206 for use in easily securing the device in the pocket of a user.
  • a mixer 220 extends from a distal end of the housing 200.
  • a push button 204 is located towards a distal end of the housing 200 for mixing and dispensing the two component substances.
  • a housing 300 comprises a push button 304 for causing the mixing and dispensing of the two component substances through a mixer 320.
  • the housing further includes a movable distal head enabling access to the two- component mixing and application mechanism. This could allow for re-filling of the pen. It could also allow a user to mitigate a clogged dispensing tip.
  • the housing 300 includes a slot 330 that receives a plunger location indicator 340.
  • the plunger location indicator 340 slides in the slot 330 according to the position of the plunger connected to the dual chambers the housing 300.
  • the plunger location indicator 340 is connected to the dual chamber plunger 118.
  • the plunger location indicator 340 will slide within the housing slot 330 and thereby provide a visual and tactile indicator to the user of the amount of component substances that have been discharged from the dual chambers 122, 124.
  • such an indication will also convey to the user the amount of component substances remaining in the dual chambers 122, 124.
  • a housing 400 may have a push button 404 located at the distal end of the housing 400 and also includes a mixer 420. Also located at a distal end of the housing 400 is a window 461 formed by a frame 460 extending around the mixer 420. The window 461 allows a user to observe the mixing of the components as they exit the dual chamber of the mechanism.
  • the frame 460 also provides structural support to the mixer 420 for those uses where a greater force may be exerted on the tip of the mixer 420 during dispensing.
  • a housing 500 may have push button 504 located at a proximal end of the housing 500 opposite the distal end where the mixer 520 is located.
  • the housing 500 may also have a window 562 enabling a user to observe the levels of the component substances contained in the dual chambers.
  • the proximal end of the device 563 is contoured. In one embodiment the contour is a beveled or scalloped shape. Such a contoured shape allows a user to spread and arrange the mixed component substance, e.g., a topical freeform radiopaque marker substance, on the patient as needed.
  • the housing may also incorporate a self-dispensing tip 564.
  • the self-dispensing tip is driven via a different internal mechanism than described in Figs. 8-9.
  • the push button 504 is instead a release latch that allows an internal spring to drive a dual chamber plunger.
  • the dual chamber plunger urges the two components to flow through the mixer.
  • the user can stop the self-dispensing by pressing the release latch once more.
  • the spring is then engaged and the force on the dual chamber plunger is halted.
  • a housing 600 may include a push button 604 for mixing and dispensing the two-component substance through an exit hole 665.
  • the mixer is not shown as it is recessed inside the exit hole 665.
  • This embodiment has no internal springs to drive a dual plunger.
  • the housing for the dual components is made of a compliant polymer bag. This bag is over-sized relative to the dimensions of the housing 600. Due to this physical interference, pressure is exerted on the compliant polymer bag when the two halves of the housing are assembled during manufacturing.
  • the push button 604 is attached to a compliant valve that opens upon pressing the push button 604.
  • the housing also may have a fin 666 disposed on the nose of the housing 600. The fin 666 enables a user to spread the mixed two component substance after it has been dispensed through the exit hole 665.

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Abstract

L'invention concerne une composition radio-opaque formulée pour permettre à un clinicien, à un technicien ou à un autre utilisateur d'appliquer des marquages personnalisés sur une surface, telle que la peau d'un patient ou un champ opératoire sur le patient. Plus particulièrement, la composition radio-opaque peut être utilisée pour écrire sur la surface. Les marquages peuvent être bien définis et contraster avec la surface sur laquelle ils sont appliqués. Une telle composition peut comprendre le mélange de deux composants, chaque composant ayant une base polymère siliconé pourvue d'agents radio-opaques.
PCT/US2021/072842 2020-12-10 2021-12-09 Compositions de marquage radio-opaques et leur utilisation WO2022126124A1 (fr)

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US202063123867P 2020-12-10 2020-12-10
US63/123,867 2020-12-10
US202063126431P 2020-12-16 2020-12-16
US63/126,431 2020-12-16

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