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WO2024249649A1 - Système et procédé pour système de cathéter avec noyau radioprotecteur - Google Patents

Système et procédé pour système de cathéter avec noyau radioprotecteur Download PDF

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Publication number
WO2024249649A1
WO2024249649A1 PCT/US2024/031698 US2024031698W WO2024249649A1 WO 2024249649 A1 WO2024249649 A1 WO 2024249649A1 US 2024031698 W US2024031698 W US 2024031698W WO 2024249649 A1 WO2024249649 A1 WO 2024249649A1
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WO
WIPO (PCT)
Prior art keywords
core
catheter system
sleeve
patient
catheter
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2024/031698
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English (en)
Inventor
Peter ORIO
Paul L. NGUYEN
Katelyn CROUSE
Todd TABER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Brigham and Womens Hospital Inc
Original Assignee
Brigham and Womens Hospital Inc
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.)
Filing date
Publication date
Application filed by Brigham and Womens Hospital Inc filed Critical Brigham and Womens Hospital Inc
Publication of WO2024249649A1 publication Critical patent/WO2024249649A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/18—Materials at least partially X-ray or laser opaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/02—Inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1078—Urinary tract
    • A61M2210/1085—Bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N2005/1092—Details
    • A61N2005/1094—Shielding, protecting against radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N2005/1092—Details
    • A61N2005/1096—Elements inserted into the radiation path placed on the patient, e.g. bags, bolus, compensators

Definitions

  • the present disclosure provides a catheter system for use with radiation therapy.
  • the catheter system can include a core that is formed from a radioprotective material.
  • the core may extend from a proximal end to a distal end along a longitudinal axis.
  • the catheter system further includes a sleeve formed from a biocompatible material that extends about the core along the longitudinal axis.
  • the sleeve may have an outer wall that is configured to extend through a biological lumen of a patient.
  • the sleeve and the core are configured to cooperate to reduce a radiation dose received by tissue or organs in the patient that are proximate to the catheter system.
  • the core may absorb or scatter radiation incident upon the radioprotective material, and the sleeve may absorb at least some of the radiation scattered by the core.
  • the present disclosure provides a catheter system for use with radiation therapy.
  • the catheter system can include a core formed from a radioprotective material that extends from a proximal end to a distal end along a longitudinal axis.
  • the core may be configured to absorb or scatter radiation incident upon the radioprotective material, reducing a radiation dose received by tissue or organs in the patient proximate to the catheter system.
  • the catheter system further includes a sleeve formed from biocompatible material. The sleeve may extend about the core along the longitudinal axis and have an outer wall. The catheter system may be configured to extend through a biological lumen of a patient.
  • the present disclosure provides a method of manufacturing a radioprotective catheter system. The method includes forming a core that extends from a proximal end to a distal end along a longitudinal axis.
  • the core may comprise a radioprotective material.
  • the method further includes forming a sleeve around the core along the longitudinal axis to form a closed lumen surrounding the core.
  • the sleeve may be formed from a biocompatible material.
  • the catheter system may be configured to extend through a biological lumen of a patient. DESCRIPTION OF THE DRAWINGS [0007]
  • FIG.1 is a plan view of a radioprotective catheter according to some aspects of the present disclosure.
  • FIG.2 is a cross-sectional view of an example radioprotective catheter according to some aspects of the present disclosure.
  • FIG.3 is another cross-sectional view of another example radioprotective catheter according to further aspects of the present disclosure.
  • FIG.4 is a plan view of another example catheter according to some aspects of the present disclosure.
  • FIG.5A is an example cross-sectional view of the catheter of FIG.4 according to some aspects of the present disclosure.
  • FIG.5B is an example cross-sectional view of the catheter of FIG.4 according to other aspects of the present disclosure.
  • FIG.5C illustrates an example cross-sectional view of the catheter of FIG.4according to further aspects of the present disclosure.
  • FIG.6 shows plan and detailed views of another example catheter according to some aspects of the present disclosure.
  • FIG.7 is an example model used to calculate dose reduction for a radioprotective catheter according to some aspects of the present disclosure.
  • FIG.8 is a graph of example radiation dose profiles for various core materials according to some aspects of the present disclosure.
  • DETAILED DESCRIPTION [0018]
  • the catheter may be placed inside a biological lumen during radiation therapy to act as a radioprotectant to reduce the radiation dose received by surrounding or non-targeted tissues.
  • the biological lumen may be a urethra, rectum, esophagus, or other structure and the radiation therapy may be targeting the prostate or other nearby organ.
  • the radioprotective catheter may protect proximate non-targeted structures, such as to protect rectal mucosa or vaginal mucosa, esophagus or nasopharynx, or other structures, depending upon the location of the target structure or anatomy.
  • the catheter may be formed using multiple materials and/or have multiple layers.
  • the catheter may include an outer lumen or sleeve and an inner core.
  • the inner core may be soft or flexible and capable of bending sufficiently to facilitate insertion into the biological lumen, such as urethra or other anatomical structure.
  • the core may be formed from or include a radio-opaque or radio-protective material.
  • the catheter may have an optional balloon port, balloon inflation lumen, and balloon that can inflate in the bladder of a patient or subject to help maintain the catheter in a desired position while in use.
  • FIGS.1 and 2 one example of a catheter system 100 is illustrated.
  • FIG. 1 shows a plan view of the catheter system 100.
  • the catheter system 100 includes a closed outer layer or external sleeve 102.
  • the sleeve 102 may be formed from a biocompatible material that can be inserted into a patient.
  • the catheter system 100 can have a distal end 106 that is configured to be inserted into a patient’s biological lumen, for example into a urethra, and a proximal end 104 designed to provide access to the catheter system 100 from the outside of the patient while the distal end 106 is inserted into the patient.
  • the catheter system 100 extends from the proximal end 104 to the distal end 106 along a longitudinal axis 108.
  • the catheter system 100 can have a length 109 sufficient to reach the target anatomy.
  • the length 109 may be designed to reach from the outside of the patient to the bladder of the patient.
  • FIG.2 shows a cross-sectional view of the catheter system 100 through a surface of the catheter system 100 that is perpendicular to the longitudinal axis 108.
  • the catheter system 100 may include the sleeve 102 that forms an outer wall 110 and an inner wall 112.
  • the outer wall 110 defines an outer circumference extending along a circumferential direction 114 defined by an angle ⁇ 116.
  • the catheter system 100 can have a core 118.
  • the core 118 may be formed of a flexible material that has radioprotective properties, which may be referred to as a “radioprotectant” because it absorbs, reflects, or otherwise controls the transmission of ionizing radiation through the core 118.
  • This radioprotective material can help to protect tissues or organs that are proximate to the catheter system 100 by reducing the radiation dose such tissues receive.
  • the core 118 provides a flexible, low half-value layer (HVL) to block transmission of radiation therethrough.
  • the HVL describes the thickness of material penetrated by 1 ⁇ 2 of the radiation as a function of the incident energy.
  • the core 118 may include lead, which is low in cost, highly accessible, and has a high rate of radiation attenuation.
  • Table I shows the HVL of lead compared to that of tissue and aluminum for three different energy levels.
  • Table I HVL values Material HVL at 30 keV HVL at 60 keV HVL at 120 keV Tissue 20.0 35.0 45.0 Aluminum 2.3 9.3 16.6 Lead 0.02 0.125 0.15
  • Radioprotective materials that may be incorporated into the core 118 can also be described based on linear attenuation coefficients according to: ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ (1)
  • intensity of the beam at distance x, and ⁇ ⁇ is the intensity of the beam at its origin.
  • the core 118 may additionally or alternatively include other radioprotective materials, such as tungsten, titanium, bismuth, gold, osmium, uranium, tantalum, impregnated polymer composite materials, or a combination thereof.
  • the core 118 may be constructed from a soft or flexible material, such as soft lead, or include quantities of a plurality of materials selected to allow for sufficient flexibility or bending to insert the catheter system 100 into the body of the patient, for example in the urethra.
  • the sleeve 102 can be used to protect the core 118 and/or protect the biological lumen of the patient from direct interaction with the core 118. In this way, the sleeve 102 can provide a barrier between the core 118 and the patient.
  • the core 118 may be co-extensive with or may only extend along a part or portion of the sleeve 102.
  • the sleeve 102 may fully surround the core 118, forming a closed lumen such that none of the core 118 is exposed to the patient or user.
  • the sleeve 102 can fully surround the core 118 in a circumferential direction transverse to the longitudinal axis 108.
  • the sleeve 102 may be constructed from biocompatible materials, such as silicone, latex rubber, polytetrafluoroethylene (e.g., Teflon®), or others, including Polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polymethylmethacrylate (PMMA).
  • PVC Polyvinylchloride
  • PE polyethylene
  • PP polypropylene
  • PMMA polymethylmethacrylate
  • the sleeve 102 and core 118 can be configured to cooperate to provide radiation dose reduction via the radioprotective properties of the core 118 while providing a barrier between the core and the patient via the biocompatible properties of the sleeve 102.
  • the sleeve 102 can be dimensioned and designed to create a space to absorb scattered radiation that is reflected off the radioprotective core 118.
  • the sleeve 102 may function to absorb radiation scatter that is reflected by the surface of the core 118. Thus, as will be described, a thickness of the sleeve 102 can be selected based on the tradeoff between patient comfort and the level of scatter protection.
  • the cross-sectional area of the sleeve 102 may be circular, nearly circular, elliptical, another geometric shape, or another abnormal shape.
  • the sleeve 102 can be characterized with a distance D s 120 that describes the length or distance across the cross-sectional area of the sleeve 102. For example, if the sleeve 102 is circular, Ds 120 may be the diameter of the sleeve 102 measured at the outer wall 110.
  • Ds 120 may also describe the average distance across the cross- sectional area of the sleeve 102.
  • D s 120 can describe the distance from a position on the outer wall 110 of the sleeve 102, through the center 111 of the cross-sectional area of the catheter system 100 to the periphery or outer wall 110 of the sleeve 102 as a function of the position around the circumferential direction 114, e.g., D s ( ⁇ ) for 0° ⁇ ⁇ ⁇ 360°.
  • the sleeve 102 may also be characterized by a thickness T s 122 that describes the distance between the outer wall 110 and the inner wall 112 of the sleeve 102.
  • Ts 122 may also be uniform about the core 118 or may vary and be described as a function of ⁇ (e.g., Ts( ⁇ ) for 0° ⁇ ⁇ ⁇ 360°.
  • the cross-sectional area of the core 118 may be circular, nearly circular, elliptical, another geometric shape, or another abnormal shape.
  • the core 118 can be characterized with a distance Dc 124 that describes the length or distance across the cross- sectional area of the core 118. For example, if the core 118 is circular, D c 124 may be the diameter of the core 118. D c 124 may also describe the average distance across the cross- sectional area of the core 118.
  • Dc 124 can describe the distance between a position on the periphery of the core 118, through the center 111 of the cross-sectional area of the catheter system 100 and to a position on the opposite periphery of the core 118 as a function of the position in the circumferential direction 114, e.g., Dc( ⁇ ) for 0° ⁇ ⁇ ⁇ 360°.
  • Dc 124 may be approximately equal to an inner distance across opposing sides of the inner wall 112 of the sleeve 102. Put another way, the periphery of the core 118 may abut the inner wall 112 of the sleeve 102.
  • these dimensions may vary to facilitate insertion and removal of the core 118 from the sleeve 102, if desired.
  • the dimensions of the catheter e.g., D c , D s , T s
  • the distance Dc 124 may be determined based on the tradeoff between patient comfort and radiation attenuation.
  • the distance D s 120 and thickness T s 122 may be determined based on the tradeoff between patient comfort and scatter absorption.
  • the maximum distance Ds of the sleeve may be set to the minimum inner diameter of the urethra.
  • the maximum D s 120 may also be determined based on patient tolerance or the ability to insert the catheter system 100.
  • D s 120 may be limited by the maximum value 12 mm, 10 mm, 8 mm, 6 mm, 4 mm, or other value selected based on patient considerations and radiation considerations.
  • the lower limit of Ds 120 may be set to achieve sufficient radiation scatter absorption based on the material of the core 118 and the sleeve 102.
  • the minimum Ds 120 may be set to 2 mm, 4 mm, 6 mm, 8 mm, 10 mm, and so forth.
  • the thickness Ts 122 may have a value within a range of 0.1 mm to 2 mm.
  • D c 124 may be limited by a maximum of 12 mm, 10 mm, 8 mm, 6 mm, or 4 mm, or the like and/or a minimum of 1 mm, 2 mm, 4 mm, 6 mm, 8 mm, 10 mm, or the like.
  • the core 118 may have the same or different shape as the sleeve 102.
  • the core 118 can be centered inside the sleeve 102 or may be offset.
  • a non-limiting example of another catheter system 300 is shown in FIG.3, in which T s is a value that is a function of the position around the circumference, ⁇ , e.g. Ts( ⁇ 1) 302 and Ts( ⁇ 2) 304.
  • the catheter system 300 may be deployed with the thicker region of the sleeve (e.g., T s ( ⁇ 1 ) 302) aligned with a radiation source 306 and the thinner region of the sleeve (e.g., T s ( ⁇ 2 ) 304) opposite of the radiation source, as shown in FIG.3.
  • the thickness of the sleeve 102 can be maximized or increased in the region of radiation scatter, while also maximizing the pathlength of the radiation beams through the core 118.
  • the shapes and distances (e.g., D c 124 and D s 120) of the cross-sectional areas of the core 118 and sleeve 102 may be constant across axis 108 for the whole length 109 of the catheter system. Alternatively, they may vary along the length of the catheter system.
  • the core 118, sleeve 102, or both may have increasing sizes (e.g., D c , D s , or both) along axis 108 in the distal direction. In this way, the catheter system 100, 300 can have increased radiation protection in or near the prostate, for example, with decreased catheter size farther away from the prostate to improve patient comfort.
  • the core 118 may be manufactured through extrusion in the preferred diameter or shape (e.g., Dc 124), cut to length, and machine finished. Alternatively, the core 118 may be cast into a specific shape to comply with anatomy and improve patient comfort.
  • the sleeve 102 may be formed by pouring the sleeve material in liquid form, such as liquid silicone, into a room temperature vulcanization (RTV) mold shaped to the desired thickness, shape, distance, length, and so forth.
  • RTV room temperature vulcanization
  • the sleeve 102 may be cast onto an existing core insert (over-molded), or the core insert may be assembled into the catheter system 100 after the silicone or other material is cured, depending on desired design geometry.
  • the catheter system 400 may further include a balloon port 402 that is located at or near the proximal end providing access to the balloon port 402 from outside of the patient.
  • the balloon port 402 can be in fluid communication with a balloon 404 that is located distally from the balloon port 402.
  • the balloon 404 may be located at the farthest distal end of the catheter system 400 or may be located near or proximate to the distal end of the catheter system 400.
  • the catheter system 400 extends along a longitudinal axis 406 from proximal end 408 to a distal end 410.
  • the distal location of the balloon 404 may be determined by the distance through the urethra to the bladder of a patient, for example.
  • the balloon may extend circumferentially about the sleeve of the catheter.
  • the balloon 404 may be configured to fit into the bladder of the patient in order to hold the catheter system 400 in place while in use.
  • the balloon 404 may be a foley catheter balloon.
  • FIGS. 5A, 5B, and 5C Non-limiting examples of a cross-section of catheter system 400 are shown in FIGS. 5A, 5B, and 5C.
  • the catheter system 400 may include a flexible radioprotective core 504 within a closed lumen sleeve 502.
  • the catheter system 400 may further include a balloon inflation lumen 506.
  • the balloon inflation lumen 506 may be located within the sleeve 502 but outside the core 504.
  • the balloon inflation lumen may be located directly outside of the core 504, as shown in FIG.5A.
  • the balloon inflation lumen 506 may include one or more channels embedded within the sleeve 502, such as those shown in FIG.5B.
  • the balloon inflation lumen 506 may also be formed as a channel sandwiched between two sleeve layers 502a, 502b such that the channel extends along the whole circumferential direction 508 of the catheter system 400, as shown in FIG.5C.
  • the balloon inflation lumen 506 may be formed in the sleeve 502.
  • the space or channels for the balloon inflation lumen 506 may be included into the sleeve mold. After curing the sleeve 502, it can be dipped into a balloon material, such as latex, to create a thin balloon layer that can be in fluid communication with the balloon inflation lumen 506 and the balloon port 402.
  • the catheter may be cast with a single main lumen open on both ends and a smaller lumen only open on one end.
  • the side of the catheter can be punched, exposing the smaller lumen. Then, a thin film can be cast on top of the punched hole, creating the balloon.
  • fluid such as saline solution
  • the balloon may be sized to facilitate 10 cc or another desirable measure of saline solution.
  • the radioprotective core can be formed from a single piece of continuous radioprotective material.
  • the radioprotective core can be formed from several pieces of radioprotective material.
  • FIG.6 illustrates another example catheter system 600, including a detailed view with the top layer removed to show a non-limiting example of the contents of the core.
  • the core 604 can be defined by the inner wall of the sleeve 602 or may be defined by a separate lumen that runs through the sleeve 602. [0040]
  • the core 604 contains several radioprotective pellets 610. These pellets 610 can be spherical, ellipsoidal, another geometric shape, or an abnormal 3-dimensional shape.
  • the pellets may be formed from a material that attenuates radiation, such as lead, tungsten, titanium, bismuth, gold, osmium, uranium, tantalum, impregnated polymer composite materials, or a combination thereof.
  • the pellets 610 may be formed from a soft, pliable material. In other configurations, the pellets 610 may be hard and unpliable. In this case, flexibility of the core 604 can be provided by the space between pellets 610, allowing each pellet 610 to move with respect to its neighboring pellets 610 when the catheter system 600 is inserted into the patient.
  • the core 604 is not required to be constructed from a flexible material, but the system still provides a flexible core that can increase patient comfort throughout catheter insertion, patient movement, and radiation therapy.
  • the fill density of the core 604 can be determined based on the tradeoff between the effectiveness of radiation attenuation and the catheter flexibility that provides patient comfort.
  • Various shaped and sized pellets 610 can be used to provide the desired flexibility.
  • the pellets 610 may include ellipsoids with the long axes aligned along the long axis 608 of the catheter. In this way, increased flexibility can be provided orthogonally to the axis 608 while flexibility is limited along the catheter’s longitudinal axis 608.
  • each pellet 610 can also be determined based on the tradeoff between core flexibility, radiation attenuation, and complexity of manufacturing or cost.
  • each dimension (e.g., D px , D py , D pz ) of each pellet may be significantly smaller than the width of the core (e.g., Dc).
  • the size of the pellets 610 may be limited by Dpx, Dpy, and Dpz less than Dc/4, Dc/10, Dc/50, Dc/100, and so forth. While illustrated in the context of catheter system 600, the described features of a pellet- filled core can be used with other catheter systems (e.g., 100, 300, 400) described herein.
  • FIG.7 provides an illustrative example that may be used to estimate the dose reduction achieved by a radioprotective catheter system (e.g., 100, 300, 400, 600).
  • the radioprotective core may have a circular cross-sectional area with radius rc and that the radiation beams have perpendicular incidence when they contact the core.
  • a dose reduction can be calculated for a given path length ( ⁇ ⁇ ) based on the definition of the mass attenuation coefficient: ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ 3 ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ [1000] ⁇ describes core ⁇ ⁇ describes the path length through the core at each position ⁇ along ⁇ ( ⁇ ⁇ ) and ⁇ ⁇ describes the intensity of the beam at a distance ⁇ ⁇ .
  • Equation (6) can be adjusted for other core shapes or incidence angles of radiation based on the geometry of the core and radiation path through the core. Assuming a circular cross-sectional area, Equation (6) can be substituted into Equation (5) to describe the radiation dose reduction at ⁇ ⁇ .
  • the percentage of reduction in the radiation dose at ⁇ ⁇ due to the attenuation properties of the core material with a mass attenuation coefficient of ⁇ / ⁇ can be described as: ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ (7) [0044] catheter cross-section.
  • the radiation reduction increases with increasing distance (e.g., D c ) of the core, or radius ( ⁇ ⁇ ⁇ for a circular core.
  • the core may be designed to balance patient comfort with radiation dose reduction.
  • the radiation intensity ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ is plotted for several core materials in FIG.8 assuming the model as described in FIG.7 with a core radius of ⁇ ⁇ ⁇ 3 mm.
  • the following densities and mass coefficients were used: Material Density ( ⁇ ) [g/cm 3 ] Mass coefficient ( ⁇ / ⁇ ) at 6 MeV [cm 2 /g] Lead 11.29 4.39 * 10 -2 Tungsten 19.3 4.21 * 10 -2 Bismuth 9.747 4.44 * 10 -2 Gold 19.3 4.36 * 10 -2 Osmium 22.5 4.24 * 10 -2 Uranium 18.95 4.58 * 10 -2 Tantalum 16.654 4.19 * 10 -2 [0046]
  • the radiation toxicity to surrounding tissue can be reduced by more than 20% at the center of the core, which may allow for an increase in radiation dose by 20%, improving the efficacy of radiation therapy while protecting the surrounding healthy tissue.

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Abstract

Selon certains aspects, la présente divulgation concerne un système de cathéter destiné à être utilisé avec une radiothérapie. Le cathéter peut comprendre un noyau qui est formé à partir d'un matériau radioprotecteur. Le noyau peut s'étendre d'une extrémité proximale à une extrémité distale le long d'un axe longitudinal. Le système de cathéter comprend en outre un manchon formé à partir d'un matériau biocompatible qui s'étend autour du noyau le long de l'axe longitudinal. Le manchon peut avoir une paroi externe qui est configurée pour s'étendre à travers une lumière biologique d'un patient. Le manchon et le noyau sont configurés pour coopérer pour réduire une dose de rayonnement reçue par un tissu ou des organes chez le patient qui sont à proximité du système de cathéter. Le noyau peut absorber ou diffuser un rayonnement incident sur le matériau radioprotecteur, et le manchon peut absorber au moins une partie du rayonnement diffusé par le noyau.
PCT/US2024/031698 2023-05-31 2024-05-30 Système et procédé pour système de cathéter avec noyau radioprotecteur Pending WO2024249649A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999040971A1 (fr) * 1998-02-17 1999-08-19 Advanced Cardiovascular Systems, Inc. Catheter d'application de rayonnement avec capacite d'irrigation de sang
US6338709B1 (en) * 1998-02-19 2002-01-15 Medtronic Percusurge, Inc. Intravascular radiation therapy device and method of use
US20060126789A1 (en) * 2004-12-10 2006-06-15 Carl Zeiss Stiftung Catheter with inflatable balloon assembly and optically activated x-ray source
US7744587B2 (en) * 2003-09-22 2010-06-29 Boston Scientific Scimed, Inc. Surface modified reinforcing member for medical device and method for making same
US8517906B2 (en) * 2002-11-06 2013-08-27 Hologic, Inc. Brachytherapy device
US20200139155A1 (en) * 2017-12-15 2020-05-07 Braxx Biotech Co., Ltd Catheter apparatus and brachytherapy system

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999040971A1 (fr) * 1998-02-17 1999-08-19 Advanced Cardiovascular Systems, Inc. Catheter d'application de rayonnement avec capacite d'irrigation de sang
US6338709B1 (en) * 1998-02-19 2002-01-15 Medtronic Percusurge, Inc. Intravascular radiation therapy device and method of use
US8517906B2 (en) * 2002-11-06 2013-08-27 Hologic, Inc. Brachytherapy device
US7744587B2 (en) * 2003-09-22 2010-06-29 Boston Scientific Scimed, Inc. Surface modified reinforcing member for medical device and method for making same
US20060126789A1 (en) * 2004-12-10 2006-06-15 Carl Zeiss Stiftung Catheter with inflatable balloon assembly and optically activated x-ray source
US20200139155A1 (en) * 2017-12-15 2020-05-07 Braxx Biotech Co., Ltd Catheter apparatus and brachytherapy system

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