Radiation protection shielding system and method for covering a patient - Patents.com

Abstract

A radiation protection shielding system is disclosed that includes at least one radiation protection drape sized to at least partially cover a patient from near an area where the patient will receive radiation down to the patient's feet. The radiation protection drape includes at least a first section and a second section. The first section is segmented from the second section from a first edge of the radiation protection drape to a second edge of the radiation protection drape.

Description

[Technical field]

[0001] FIELD OF THEINVENTION The present invention relates generally to the field of radiation protection devices for protection against ionizing radiation, particularly for use in medical interventions. More particularly, the present invention relates to a radiation protection shielding system comprising at least one radiation protection drape sized to at least partially cover a patient from near an area where the patient will receive radiation down to the patient's feet. The radiation protection drape may comprise at least a first section and a second section. The first section may be segmented from the second section from a first edge of the radiation protection drape towards a second edge of the radiation protection drape.

[0002] 2. Background of the Invention In radiologically guided interventional procedures using radiation systems, such as X-ray radiation systems, clinical staff, such as endovascular clinicians, are continuously exposed to ionizing radiation, most of which is scattered radiation from the patient and the operating table.

[0003] Clinical staff protect themselves from radiation in two main ways, referred to here as conventional systems: 1) radiation shielding devices (exemplified by protective shields attached to the roof or floor, radiation protection shields attached under the operating table) and 2) personal radiation shielding suits (such as lead or non-lead aprons, thyroid protection, and leaded glasses). An alternative radiation protection system could be a radiation protection patch attached to the patient to create areas of lower scattered radiation in the clinical environment. Another example is a system in which the surgeon wears a radiation protection suit attached to the floor or roof to maximize radiation protection without the need for the surgeon to carry the weight of a personal radiation shielding suit. Yet another example is to reduce radiation by a system of protective panels around the intervention area. However, no optimal radiation protection solution exists, such that conventional radiation protection systems as well as alternative radiation protection systems reveal deficiencies in protection for staff. Conventional radiation clothing systems typically only protect 75% of the staff's body, leaving the arms, legs, and head exposed to high doses of radiation. In examples having a system in which the surgeon wears a floor or roof mounted radiation protection suit (e.g. Zero-Gravity by TIDI Products, USA), the system allows only one person in the operating room to be protected, while other staff remain dependent on traditional radiation protection equipment.

[0004] The conventional protection system used today is accepted as standard and is mandatory in all interventional procedures with radiological guidance using radiation systems, such as endovascular procedures, to reduce radiation dose to clinical staff. All staff members have a dosimeter in their left breast pocket under their lead apron to monitor their personal radiation exposure. For example, in an endovascular operating room with a modern dose-optimized X-ray system equipped with a protection system as described above, the annual cumulative dose measured under the lead apron of catheterization laboratory staff is within 2-4% of the annual allowable dose of 20 mSv. Although occupational radiation dose limits are monitored and are rarely achieved, chronic exposure to low-dose radiation has been shown to have adverse biological effects that may become evident years later, such as cancer and cataracts. Furthermore, since the dose is measured on the torso under the radiation protection suit, the cumulative dose in the arms, legs, and head is not taken into account in the annual dose limit.

[0005] Personal lead or lead-free protective aprons weigh approximately 4-8 kg depending on size and level of protection. The weight of lead aprons places a significant burden on clinicians who must carry them when working in the operating room. Orthopedic injuries and disorders of the back, neck, shoulders, hips, and knees, as well as chronic fatigue, are commonplace for workers in interventional surgical environments as a result of carrying heavy personal lead protection.

[0006] Therefore, an effective radiation protection system that protects against radiation exposure to staff in radiologically guided interventional procedures and simultaneously reduces the risk of orthopedic injury and disorders among staff would be advantageous.

[0007] US Patent No. 4,670,658 discloses a multi-layer sheet with a central layer support matrix in which the radiopaque compound barium sulfate is distributed as a powder and supported by the matrix. The barium sulfate is present in an amount sufficient to block scattered radiation generated by medical radiological procedures. The multi-layer sheet is a single sheet that is disposable and designed with cost in mind. The proposed radiation protection material is barium sulfate, which is known as a cost-effective material, but at the same time has a relatively low protection performance for radiation shielding. Compatibility with the patient and the operating table is important to avoid radiation leakage and to adequately reduce radiation exposure to clinical staff, and although the proposed solution of US Patent No. 4,670,658 can reduce radiation exposure, there is an obvious risk that the inherent configuration of the solution may compromise the radiation barrier, since the barium sulfate powder makes the multi-layer sheet stiff and brittle.

[0008] Summary of the Invention Accordingly, embodiments of the present invention preferably seek to mitigate, alleviate or eliminate one or more deficiencies, shortcomings or problems in the art, as identified above, singly or in any combination, by providing an embodiment of a radiation protection system according to embodiments of the present invention.

[0009] According to a first aspect of the invention, a radiation protection shielding system includes at least one radiation protection drape sized to at least partially cover a patient from near an area where the patient will receive radiation down to the patient's feet. The radiation protection drape includes at least a first section and a second section. The first section may be segmented from the second section from a first edge of the radiation protection drape to a second edge of the radiation protection drape.

[0010] The first section may be partitioned from the second section from a first edge to a second edge of the radiation protective drape and is separable from the second section. Alternatively or additionally, the first section is partitioned from the second section from the first edge partially to the second edge. The first section may be partially separable from the second section.

[0011] The first section may have a level of radiation protection that varies across the first section.

[0012] The second section may comprise a first portion and a second portion. The first portion and the second portion may be separated along an edge of each of the first portion and the second portion. Further, each of the first portion and the second portion may comprise a fastener for temporarily securing the first portion to the second portion and unlocking the first portion from the second portion.

[0013] The radiation protection drape and / or radiation protection suit may comprise one or several radiation attenuating layers disposed between two protective layers of non-radiation attenuating material attached to each other at their periphery, thus isolating metal within the attenuating material from the exterior of the radiation protection drape and / or radiation protection suit.

[0014] The radiation protective drape may include at least one fenestration for the patient's thigh. The fenestration may be located along an edge of the first section and an edge of the second section along which the first and second sections are separated.

[0015] The second edge of the radiation protective drape may be located at the fenestration. The first section and the second section may be partitioned from the first edge to the second edge of the radiation protective drape.

[0016] The radiation protective drape may include a third section separate from the first section and the second section. The third section may be sized to partially cover the fenestrated area of ​​the radiation protective drape.

[0017] The radiation protection drape may include at least one fastening device located where the first section is separated from the second section. The fastening device may include, for example, hook and loop and / or a magnet.

[0018] The radiation protection drape may be sized to extend beyond the rim of the operating table when placed over a patient lying on the operating table. Further, the radiation protection drape may be sized to extend beyond the rim of the operating table at least partially toward the floor on at least one side of the operating table, most preferably at least 10 cm beyond the rim of the operating table. Thus, the radiation protection drape may cover the side of the patient when lying on the operating table.

[0019] The radiation protection shielding system may further comprise at least one floor or ceiling mounted radiation shielding screen positioned between clinical staff and the radiation receiving area in the upper body portion of the patient.

[0020] The radiation protective shielding system may further include at least one floor or table mounted radiation protective drape section configured to cover at least a portion of the area below the operating table, such as being sized to cover at least one long side and / or one foot end side of the operating table.

[0021] The radiation protective drape may have a radiation protection level corresponding to 0.25 to 1 mm lead equivalent, and most preferably 0.35 to 0.7 mm lead equivalent.

[0022] The radiation protection shielding system may comprise a radiation protection suit. The radiation protection suit may comprise at least one panel sized to extend over at least the front of the wearer's torso. The panel may have a radiation protection level of 0.05-0.35 mm lead equivalent. Thus, the radiation protection drape may have a higher radiation protection level than the panel of the radiation protection panel. Furthermore, if made of the same material, the panel of the radiation protection suit may be lighter per surface area than the radiation protection drape. Staff may be protected from all or substantially all of the radiation scatter from the patient by the radiation protection drape and from any residual radiation scatter by the radiation protection suit. Because there is less residual radiation scatter, the radiation protection suit may be lighter. Thus, embodiments of the present invention improve the working environment for staff in an operating room while simultaneously reducing the risk of work-related orthopedic injuries and disorders to the back, neck, shoulders, hips, and knees, as well as chronic fatigue as a result of carrying heavy personal lead protection. These benefits are provided while simultaneously improving radiation protection for staff.

[0023] Other embodiments of the invention include a radiation protective drape having slits and / or openings proximate to the patient's left and / or right radial regions. Such slits or openings allow the patient's arms to extend through the radiation barrier, thus providing easy access to the radial entry points with little additional radiation exposure to clinical staff.

[0024] In yet another embodiment of the invention, a radiation protective drape placed on the patient contains one attenuating compound and a radiation protective garment used by the clinician contains another attenuating compound.

[0025] The radiation protection drape placed on the patient may have an attenuating compound that includes primarily antimony. The radiation protection garment used by the clinician may include an attenuating compound that includes primarily bismuth and / or wolfram. The attenuating compounds in the radiation protection drape and garment may be different to provide more efficient protection. Each attenuating compound is selected to block specific wavelengths of radiation and may be arranged in this order to more efficiently reduce radiation. Thus, radiation protection per surface area is more efficient and the drapes and garments may be lighter with the benefits described herein.

[0026] In another embodiment of the invention, the radiation protection suit comprises one or several textile radiation protection panels integrated into a set of pants and shirt, thus constructing a surgical suit, such panels essentially covering the front and / or back of the wearer. The embodiments of the invention provide many benefits to the clinical staff and the patient. For example, the invention achieves enhanced protection for the clinical staff, including head, arm, and leg protection, without the need for heavy radiation protection suits. Any additional protective clothing, such as a lower protective suit to protect against residual or static scattered radiation, can reduce the level of protection and therefore be lighter. The removal of weight from the clinical staff would be beneficial in stamina and avoidance of work-related injuries and injuries, as discussed above. It also further improves the mobility and range of the operator and staff. The inherent weight of the patient drape is said to be calming and patient-friendly in the same function as having a weighted blanket. Furthermore, the benefits discussed above are available during emergency situations while the safety of the patient is not compromised due to inaccessibility to the patient's body parts. Further benefits and / or advantages of embodiments of the present invention are described in the detailed description of the invention.

[0027] It should be emphasized that the term "comprises / comprising" as used in this specification is to be interpreted as specifying the presence of stated features, integers, steps or components, but does not exclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

[0028] BRIEF DESCRIPTION OF THE DRAWINGS These and other aspects, features and advantages to which embodiments of the present invention are capable will become apparent and elucidated from the following description of embodiments of the invention, which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0029] [Figure 1a] FIG. 1 is a perspective view of an embodiment of the present invention. [Figure 1] FIG. 1 is a top view of an embodiment of the present invention in relation to a patient lying on a surgical table. [Diagram 2] FIG. 2 is a perspective view of a first section of a protective drape of an embodiment of the present invention relative to a surgical table. [Figure 3a] FIG. 2 is a perspective view of a second section of a protective drape according to an embodiment of the present invention in an unfolded position relative to a surgical table. [Figure 3b] FIG. 2 is a perspective view of a second section of a protective drape according to an embodiment of the present invention in a folded position relative to a surgical table. [Figure 4] FIG. 1 is a perspective view of an embodiment of the present invention in relation to a surgical table. [Diagram 5] 1 is a table with data from Example 1. [Figure 6] 1 is a table with data from Example 2. [Figure 7] 1 is a table with data from Example 3. [Figure 8] FIG. 11 is a top view of an embodiment of the invention described in relation to Example 4. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] Description of the embodiments Next, specific embodiments of the present invention will be described with reference to the accompanying drawings. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments described herein, but rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present invention.

[0031] The following description focuses on an embodiment of the invention applicable as a radiation protection system for medical procedures, where radiological guidance using a radiation system such as an X-ray radiation system continuously exposes intravascular staff to ionizing radiation, however, it will be appreciated that the invention is not limited to this application and may be applied to many other procedures, such as other areas where a radiation protection system may be used to protect staff from scattered radiation.

[0032] FIG. 1a shows an embodiment of a radiation protection shielding system 1 comprising at least one radiation protection drape 2 having at least one section. In some embodiments, the radiation protection shielding system also comprises a radiation protection suit 17 for staff in the operating room, as further disclosed below. In some embodiments, a radiation protection shielding system comprising a radiation shielding screen 14, shown in FIG. 1a, is also included in the radiation protection shielding system. An embodiment of the radiation protection shielding system may comprise a radiation protection drape 2 together with a radiation protection suit 17 and / or a radiation shielding screen 14. An embodiment may also comprise a radiation protection drape section 15, shown in FIG. 4, extending from the edge of the operating table towards the floor. A first operator 18 is shown standing on the long side of the operating table.

[0033] 1 illustrates an embodiment of a radiation protection shielding system 1 comprising at least one radiation protection drape 2. The radiation protection drape 2 comprises at least a first section 3 and a second section 4. The first section 3 may be segmented from the second section 4 from a first edge 5 of the radiation protection drape 2 towards a second edge 6 of the radiation protection drape. Thus, the radiation protection drape 2 may be fully or partially segmented, i.e., split or divided into multiple sections.

[0034] The radiation protection drape 2 may be sized to at least partially cover the patient from near the area where the patient receives radiation to the patient's feet. In some embodiments, the radiation protection drape 2 may be sized to cover the patient's feet. The radiation protection drape 2 may be sized to cover the patient from the torso, as shown in FIG. 1. The total length of the radiation protection drape 2 may be in the range of 60-150 cm, such as in the range of 80-110 cm. The total width of the radiation protection drape 2 may be in the range of 80-160 cm, such as in the range of 90-110 cm. The length of the first section 3 may be in the range of 20-130 cm, such as in the range of 30-60 cm. The total width of the first section 3 may be in the range of 80-160 cm, such as in the range of 90-110 cm. The length of the second section 4 may be in the range of 30-90 cm, such as in the range of 50-60 cm. The overall width of the second section 4 may be in the range of 90-180 cm, such as in the range of 100-130 cm. Thus, the radiation protective drape 2 may be sized to cover the front and sides of the patient when lying on the operating table.

[0035] In some embodiments, such as those shown in Figures 2 and 3a, the first section 3 is partitioned from the second section 4 from a first edge 5 to a second edge 6 of the radiation protective drape, such as from one long side of the drape to an opposite long side of the drape. Thus, the first section 3 may be partitioned from the second section 4 all the way from the first edge 5 to the second edge 6 of the radiation protective drape. Thus, the first section 3 may be separable from the second section 6. This improves the patient safety of the radiation protection system 1 by providing for rapid at least partial removal of the second section 4 from the patient, for example in an emergency situation.

[0036] In some embodiments, the first section 3 is partitioned from the second section 4 from the first edge 5 and partially to the second edge 6. Thus, the first section 3 may be only partially separated from the second section 4. Furthermore, the second section 4 may be folded along the separation for quick and easy access to the part of the patient covered by the second section 4. At the same time, the risk of the second section 4 dropping to the floor and becoming contaminated when folded to expose the patient is reduced. This also improves patient safety.

[0037] In some embodiments, the first section 3 has a level of radiation protection that varies across the first section. For example, a section closer to the torso has a higher level of radiation protection than a section towards the feet. In some embodiments, the higher level of radiation protection is in the range of 0.35-0.7 mm lead equivalent and the lower level of radiation protection is in the range of 0.25-0.5 mm lead equivalent. The level of radiation protection may vary in a stepped or continuous manner from a first end of the first section 3 to an opposing end of the first section 4.

[0038] In some embodiments, such as shown in Figures 3a-3b, the second section 4 may comprise a first portion 4a and a second portion 4b. The first portion 4a and the second portion 4b may be separated along the edges 7a, 7b of each of the first portion 4a and the second portion 4b. Thus, the first portion 4a and the second portion 4a may be separated from the unfolded position as shown in Figure 3a and placed in the folded position as shown in Figure 3b. Each or both of the first portion 4a and the second portion 4b may be foldable, such as to the side of the patient. Thus, quick and easy access to the area of ​​the patient covered by the second section 4 is facilitated to improve patient safety. As much of the patient as possible is covered by the radiation protection drape 2, minimizing radiation scatter, while also facilitating further access to the area where the patient receives radiation in the area covered by either of the portions. Thus, the second section 4 may be separated from the top end of the second section 4 towards the opposite bottom end of the second section 4.

[0039] In some embodiments, each of the first and second parts 4a, 4b may comprise at least one fastening device 8a, 8b, 8c for temporarily fastening and unlocking the first part 4a to and from the second part 4b. The fastening device 8a, 8b, 8c may comprise a hook and loop system or a magnet attached to each of the first and second parts 4a, 4b. Thus, accidental separation of the first and second parts 4a, 4b is provided. Thus, accidental exposure to radiation scatter is avoided.

[0040] The first and second portions 4a, 4b may be sized such that they overlap in the area where they are separated. The overlap may be in the range of 1-10 cm. Such overlap provides protection from scattered radiation in the separation between the first and second portions 4a, 4b.

[0041] In some embodiments, the first and second parts 4a, 4b of the second section 4 are partially permanently attached to the first section 3 at the lower ends of each of the first and second parts 4a, 4b. Again, this prevents accidental separation of the first and second parts 4a, 4b when in the folded position, as well as preventing either of the first and second parts 4a, 4b from falling and becoming contaminated during an interventional procedure.

[0042] In some embodiments, the closure indicator is located at the overlap between the first section 3 and the second section 4 and / or between the first portion 4a and the second portion 4b. The closure indicator is configured to detect whether the sections 3, 4 and / or portions 4a, 4b are fully closed. Such a detection system may be provided by an electrical system having conductors that create a closed circuit when the sections 3, 4 and / or portions 4a, 4b are fully closed. The electrical system may alternatively or additionally be wireless, such as a conductive system including a magnet as described herein. A closure indicator may also be provided on the table-mounted radiation protection drape section 15 (described below) that detects when the drape is fully attached to the operating table. The closure indicator for the table-mounted radiation protection drape section 15 may be provided separately from the closure indicators of any of the sections 3, 4 and / or portions 4a, 4b. Alternatively, a common closure indicator is provided on the table-mounted radiation protection drape section 15 and one or more of the sections 3, 4 and / or portions 4a, 4b. A closure indicator may be provided with any of the embodiments described herein to further enhance the safety of embodiments of the present invention, ensuring that atmospheric scatter does not penetrate the radiation barrier in sections of the radiation shielding protection system that are not completely closed.

[0043] In some embodiments, such as that shown in Fig. 3b, the first and second parts 4a, 4b of the second section 4 are permanently or temporarily connected with one or several straps 9a, 9b having a width smaller than the length of the first and second parts 4a, 4b. This prevents accidental separation of the first and second parts 4a, 4b when in the folded position, as well as from either the first or second part 4a, 4b falling off and becoming contaminated during an interventional procedure. This also contributes to the safety of the embodiments of the invention.

[0044] The radiation protection drape 2 may comprise at least one fenestration 10 for the thigh. The fenestration 10 may be located along the edge of the first section 3 and / or along the edge of the second section 4 along which the first section 3 and the second section 4 are divided. In the embodiment of Fig. 1, Fig. 3a and Fig. 4, the fenestration 10 is a cut-out section at the end of the second section 4 located towards the first section 3. This allows for easy adjustment of the size and position of the fenestration 10, thus obtaining optimal access to the entry point and minimizing the fenestration surface to reduce radiation leakage. In another embodiment, the fenestration 10 is a cut-out section at the end of the first section 3 located towards the second section 4. The cut-out section may have a square shape.

[0045] 4, the second edge 6a of the radiation protection drape 2 may be located at the fenestration 10. Thus, the first section 3 and the second section 4 may be partitioned from the first edge 5 to the second edge 6a of the radiation protection drape 2. Thus, a portion of the first section 3 may be permanently joined to a portion of the second section 4. Furthermore, a first portion of the fenestration 10 may be located at the first portion 4a and a second portion of the fenestration 10 may be located at the second portion 4b of the second section.

[0046] Either the first section 3 or the second section 4 may be placed under a sterile barrier. Thus, the radiation protection drape may be for multiple use. This achieves improved radiation protection of the radiation protection drape 2. Radiation protection drapes made for single use use less efficient radiation protection materials for cost reasons, while multiple use drapes can be made from more efficient radiation protection materials. However, over time, multiple use drapes are more cost-effective. Thus, embodiments of the present invention are cost-effective and at the same time provide improved safety.

[0047] As shown in FIG. 1, the radiation protection drape may comprise a third section 11 separated from the first and second sections. The third section 11 may be sized to partially cover the fenestration 10 of the radiation protection drape 2. The third section may have a length in the range of 20-60 cm and a width in the range of 40-80 cm. Thus, the fenestration 10 may be large enough to access both the left and right thighs of the patient. At the same time, either the left or right thigh of the patient may be covered by the third section 11. This reduces scattering from unprotected areas, improving safety and at the same time improving the flexibility of the radiation protection system 1.

[0048] In some embodiments, such as shown in FIG. 2 according to the second section 3, the radiation protection drape 2 may be sized to extend beyond the rim 12 of the operating table 13 when placed over a patient lying on the operating table 13. Furthermore, the radiation protection drape 2 may be sized to extend beyond the rim 12 of the operating table 13 and at least partially towards the floor on at least one side of the operating table 13. In some embodiments, the radiation protection drape 2 extends at least 10 cm beyond the rim of the operating table 13 when placed over the patient. Thus, the radiation protection drape can cover the side of the patient when lying on the operating table. This provides better protection from radiation scatter and improves safety.

[0049] As shown in Figures 1a and 1, the radiation protection shielding system 1 may further comprise at least one floor or ceiling mounted radiation shielding screen 14 positioned between clinical staff and radiation receiving areas in the upper body portion of the patient, thereby reducing radiation scatter from unprotected radiation areas of the patient, such as from the upper part of the patient's torso, towards staff.

[0050] 4, the radiation protection shielding system 1 may further include at least one floor or table mounted radiation protection drape section 15 configured to cover at least a portion of the area under the operating table 13. The floor or table mounted radiation protection drape section 15 may be sized to cover at least one long side and / or at least one foot end side of the operating table 13, as shown in FIG.

[0051] 2, a radiation protective drape, such as either the first section 3 or the second section 4, may include at least one recess 16 along an edge of the drape. The recess may be sized and positioned to prevent the drape 2 from covering any control panels of the medical equipment.

[0052] The radiation protection drape 2 and any section of the radiation protection system may have a radiation protection level corresponding to 0.1 to 1 mm lead equivalent, most preferably 0.35 to 0.7 mm lead equivalent.

[0053] As shown in FIG. 1a, the radiation protection shielding system may comprise a radiation protection suit 17. The radiation protection suit 17 may comprise at least one panel sized to extend over at least the front of the wearer's torso. The panel may have a radiation protection level of 0.05-0.35 mm lead equivalent. Thus, the radiation protection drape 2 may have a higher radiation protection level than the panels of the radiation protection suit 17. Furthermore, when made of the same material, the panels of the radiation protection suit 17 may be lighter per surface area than the radiation protection drape 2. The staff may be protected from all or substantially all of the radiation scatter from the patient by the radiation protection drape 2 and from any residual radiation scatter by the radiation protection suit 17. Because there is less residual radiation scatter, the radiation protection suit 17 may be lighter. The radiation protection suit 17 may be, for example, an apron with front protection and / or rear protection. Other embodiments of the garment include a shirt and pants set with front and / or rear protection. The radiation protection material in the radiation protection suit 17 may optionally comprise a fibrous radiation protection material including radiation protection filaments arranged as a woven fabric. Thus, embodiments of the present invention improve the working environment for staff in the operating room while simultaneously reducing the risk of work-related orthopedic injuries and disorders to the back, neck, shoulders, hips, and knees, as well as chronic fatigue as a result of carrying heavy personal lead protection. These benefits are provided while simultaneously improving radiation protection for staff.

[0054] The radiation protective drape 2 and / or radiation protective garment 17 of the embodiments of the present invention may be made of materials disclosed in WO2014163574 by the same applicant as the present invention, which is incorporated herein for all purposes in its entirety. For example, the radiation protective drape 2 and / or radiation protective garment 17 of the embodiments may comprise one or several layers of materials as disclosed in WO2014163574, such as to achieve the various radiation protections discussed above.

[0055] In Figures 5-7, data from three examples are shown. Examples 1 and 2 include data from an embodiment of the invention where a radiation protection drape was placed over the patient area on the operating table during measurements. Example 3 is comparative data from a study where no radiation protection was used placed over the patient area on the operating table to protect against radiation scatter. The letters A-H and numbers 1-10 in the tables of Figures 5-7 constitute positions in a matrix where A is located on the right anterior chest of the first operator and position H is located under the left arm of said operator. Position 1 is in the upper chest of the first operator and position 10 is in the knee area of ​​said operator. The units in the tables of Figures 5-7 are millisieverts (mSv) and are extrapolated to 250 procedures to represent the estimated annual dose to the first operator.

[0056] Example 1 The table in FIG. 5 contains data from Example 1. A radiation protection shielding system according to an embodiment of the invention was created by utilizing a radiation protection drape with 0.5 mm lead equivalent covering the patient from the chest down and covering the legs with fenestration in the thigh, a table-mounted lead shield (Rampart M1128) with 1.0 mm lead equivalent installed between the patient's head and the operator, and a table-mounted radiation protection curtain with 0.5 mm lead equivalent along the side of the operating table to protect against radiation entering under the table. The radiation protection drape overlapped with the radiation protection table curtain, thus avoiding static radiation from passing through the radiation protection barrier. Thirty-four interventions were performed in this study (coronary angiography, PCI, CTO-PCI, alcohol septal ablation, and aortic valve intervention). A radiation protection apron with 0.5 mm lead equivalent was fitted with 72 thermoluminescent dosimeters (DXT-RAD Ringlets TLD-100) and placed over the outer front of the apron on the torso up to the knee area of ​​the first operator. During each intervention data were registered and analyzed at the end of the study. The results were extrapolated to 250 procedures to represent the estimated annual dose for the first operator. The average individual dose equivalent extrapolated to the annual dose was measured outside the radiation protection apron of the first operator to be 0.3 mSv. The table in Figure 5 shows the doses measured at random positions on the abdomen of the first operator.

[0057] Example 2 The table in FIG. 6 contains data from Example 2. A radiation protection system according to an embodiment of the invention was created by utilizing a radiation protection drape with 0.5 mm lead equivalent covering the patient from the chest down and covering the legs with fenestration in the thigh, a roof-mounted lead screen (Mavig GmBH) with 0.5 mm lead equivalent placed between the patient's head and the operator, and a table-mounted radiation protection curtain with 0.5 mm lead equivalent along the side of the operating table to protect against radiation entering under the table. The radiation protection drape overlapped with the radiation protection table curtain, thus avoiding static radiation from passing through the radiation protection barrier. In this study, 38 interventions were performed (coronary angiography, PCI, CTO-PCI, and aortic valve intervention). The radiation protection apron with 0.5 mm lead equivalent was fitted with 72 thermoluminescent dosimeters (DXT-RAD Ringlets TLD-100) and placed over the apron's outer front on the torso up to the knee area of ​​the first operator. During each intervention data were registered and analyzed at the end of the study. The results were extrapolated to 250 procedures to represent the estimated annual dose for the first operator. The average individual dose equivalent, extrapolated to the annual dose, was measured to be 0.3 mSv outside the radiation protection apron for the first operator. The table in Figure 6 shows the doses measured at random positions on the abdomen of the first operator.

[0058] Example 3 The table in Figure 7 contains the data from Example 3. A conventional system without radiation protection above the patient was used, a roof-mounted lead screen with 0.5 mm lead equivalent (Mavig GmBH) was placed between the patient and staff using a lead radiation protection apron with 0.5 mm lead equivalent (Mavig GmBH). A table-mounted radiation protection curtain with 0.5 mm lead equivalent along the side of the operating table was used to protect against radiation entering under the table. In this study, 35 interventions were performed (coronary angiography, PCI, CTO-PCI, and aortic valve intervention). The radiation protection apron was fitted with 72 thermoluminescent dosimeters (DXT-RAD Ringlets TLD-100) and placed over the front of the apron on the torso up to the knee area of ​​the first operator. During each intervention, data were registered and analyzed at the end of the study. The results were extrapolated to 250 procedures to represent the estimated annual dose for the first operator. The average individual dose equivalent, extrapolated to an annual dose, was measured outside the radiation protection apron for the first operator to be 2.1 mSv. The table in Figure 7 shows the doses measured at random positions on the abdomen of the first operator.

[0059] Conclusions from Examples 1, 2, and 3 Using the embodiments of the present invention visualized by Examples 1 and 2, the first operator's exposure is reduced by a factor of 7 based on average values ​​compared to the conventional radiation protection device displayed in Example 3. For individual locations on the first operator's body, such as the lower body (positions 5-9) and the first operator's left chest side (positions C-D), the reduction may be greater.

[0060] The lead equivalence described herein may be measured according to standard IEC 61331-1:2014.

[0061] Example 4 Measurements of radiation exposure indicate the benefit of radiation protection for medical personnel using embodiments of the present invention. The data presented in Table 1 below was collected from a cardiology intervention within the specialty of Percutaneous Coronary Intervention (PCI). The dosimeter is placed on the first operator positioned next to the operating table towards the patient's leg in the area around the radial position. In Figure 8, the position of the first operator relative to the operating table is indicated with FO1.

[0062] The X-ray equipment used during the measurements was a Philips Multi Diagnost Eleva FD (Koninklijke Philips Electronics NV). The operating table was at a 0 degree angle and the X-ray tube position under the table was used at the usual rotation angle for cardiovascular interventions. The tube voltage was approximately 90 kV. In all measurements, a RaySafes (Unfors RaySafe AB, Billdal, Sweden) i3 real-time dosimeter system was used to indicate the amount of scattered radiation exposed to the first operator. The dosimeters were placed in four different dosimeter positions, all of which were outside the radiation protection apron on the abdomen of the first operator. In Table 1, the four different dosimeter positions (DPs) of the first operator are indicated as DP1, DP2, DP3, and DP4. DP1 was placed on the right side of the chest, DP2 on the left side of the chest, DP3 on the left side of the buttocks, and PD4 in the middle of the abdomen. A ceiling-mounted lead screen 114 manufactured by Mavig (Mavig Stahlgruberring 5, Munich, Germany) of 0.5 mm lead equivalent was used during the intervention. A radiation protection drape section 115 formed a table skirt on the side of the operating table from the patient's feet to shoulder height. The table skirt was manufactured by Kenex (Kenex, Greenway, Harlow Business park, Harlow, England) of 0.5 mm lead equivalent and was placed on the side of the operating table with the table skirt extension hinged from the operating table (partially shown in Figure 8).

[0063] 8 shows a radiation protection shielding system according to an embodiment of the invention described above that was used during the measurements of Example 4. The radiation protection shielding system included a radiation protection drape sized to partially cover the patient from near the area where the patient would receive radiation to the patient's feet. The feet were covered by the radiation protection drape. The radiation protection drape included at least a first section and a second section. The first section was segmented from the second section from a first edge of the radiation protection drape toward a second edge of the radiation protection drape.

[0064] The first section was partitioned from the second section from a first edge to a second edge of the radiation protective drape and was separable from the second section, however, this is not required in all embodiments of the present invention.

[0065] The first section was partitioned from the second section from the first edge partially to the second edge, and the first section was partially separable from the second section, although this is not required in all embodiments of the invention.

[0066] The first section had varying levels of radiation protection across the first section, however, this is not necessary in all embodiments of the present invention.

[0067] The second section comprises a first portion and a second portion separated along an edge of each of the first portion and the second portion and provided with fasteners to temporarily secure the first portion to the second portion and unlock the first portion from the second portion, although this is not required in all embodiments of the invention.

[0068] The radiation protection drape was provided with one fenestration for the patient's thigh, the fenestration being located along the divider between the first and second sections, however, this is not necessary in all embodiments of the invention.

[0069] The second edge was located at the fenestration and the first section and second section were partitioned from the first edge to the second edge, however, this is not required in all embodiments of the invention.

[0070] The radiation protective drape included a third section separate from the first and second sections and sized to partially cover the fenestrated area of ​​the radiation protective drape, however, this is not necessary in all embodiments of the present invention.

[0071] The radiation protection shielding system may include a fastening device in the form of a magnet located at a location where the first portion is separated from the second portion, however, this is not required in all embodiments of the invention.

[0072] The radiation protection drape was sized such that when placed over the patient lying on the operating table, it would extend approximately 10 cm beyond the rim of the operating table on the long side facing the first operator, toward the floor on the side of the table, and beyond the rim of the operating table to cover the side of the patient when lying on the table, however, this is not necessary in all embodiments of the invention.

[0073] A ceiling-mounted radiation shielding screen 114 was placed between the clinical staff and the radiation-receiving area of ​​the patient's upper body, however, this is not required in all embodiments of the invention.

[0074] The radiation protection shielding system included a radiation protection drape section attached to the table and configured to cover at least a portion of the area under the table.

[0075] In combination with the radiation protection drape, an apron-like radiation protection suit was used by the first operator, however, this is not necessary in all embodiments of the present invention.

[0076] On the patient, a radiation protection drape having a first section 103 and a second section 104, with a lead equivalent of 0.5 mm, was fitted as shown in FIG. 8. The second section 104 formed a chest blanket and was placed on the patient's lower abdomen. The second section 104 comprised woven radiation protection material Texray AB (Texray AB, Stena Center, Goteborg, Sweden) from the applicant of the present invention, further described in European Patent Specification No. 2981975 (Radiation Protective Material), which is incorporated herein for all purposes. The woven radiation protection material of the second section 104 included a lead equivalent of 0.50 mm. Two layers of woven radiation protection material, each with a lead equivalent of 0.25 mm, were placed on top of each other to increase the protection level to about a lead equivalent of 0.50 mm, forming the second section 104. In the embodiment of Example 4, the second section was sectioned along its center to form a first portion 104a and a second portion 104b, as described above with respect to the various embodiments. The first portion 104a and the second portion 104b overlapped and were interconnected by a magnet. This helped to hold the first portion 104a and the second portion 104b tightly together, as also displayed in Figures 3 and 4, and also allowed easy access to the patient in case of emergency treatment. The first section 103 was placed on the patient from the thighs onwards, forming a foot blanket covering the lower part of the patient's body, including the feet. The first section 103 was provided with the same woven fabric radiation protection material as the second section 104. The top 20 cm (towards the thighs) of the first section 104 was provided with a double layer of woven fabric radiation protection material, each layer with a lead equivalent of 0.25 mm. The lower portion (towards the foot) of the first section 103 comprised one layer of woven radiation protection material having a lead equivalent of 0.25 mm. A third section 111 of the radiation protection system formed a patch was used to cover the thigh fenestration 110 (placed to the side of the operating table in FIG. 8 for illustrative purposes). The third section 111 had limited effect on reducing radiation, but was used in this example to mitigate any risk of scattered radiation emanating from the thigh.The third section 111 was provided with the same woven radiation protection material as the second section 104. Two layers of 0.25 mm lead equivalent each were used in the third section 111. During the intervention, the third section 111 was placed over the fenestration (Z4).

[0077] In Table 1, the radiation exposure to the dosimeter placed on the first operator in the intervention area during the embodiment of the invention described in Example 4 is presented. The values ​​in Table 1 are in microsieverts and the average exposure is the average recorded exposure to the first operator. The average reduction efficacy indicates the quotient between the average exposure to the first operator and the radiation dose, represented by the dosimeter placed under the patient's head. This value may vary depending on the type of intervention and the time of image guidance required during the intervention. As can be seen in Table 1, the radiation exposure registered under the patient's head was highest in the case of patient 4, which is an indication that more radiation image guidance was used than in the cases of patients 1 to 3. In the case of patient 2, the radiation exposure was the lowest.

[0078] It can be concluded that the embodiment of Example 4 effectively reduces radiation exposure to the first operator, reducing radiation by 99% to 100%. By emitting a registered level of radiation to the first operator, the need for wearable radiation protection is reduced, allowing a radiation protection suit with a lower level of protection to be carried, or no wearable radiation protection suit is required. Thus, the embodiment of the invention shown in Example 4 provides many benefits to clinical staff and patients, as discussed above in the "Summary of the Invention" and "Description of the Embodiments" sections.

[0079] [Table 1]

[0080] As will be apparent, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form further embodiments, all of which fall within the scope of the present disclosure.

[0081] In particular, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, unless otherwise stated or understood otherwise within the context in which it is used, is intended to generally convey that certain embodiments include certain features, elements, and / or conditions, while other embodiments do not. Thus, such conditional language does not generally imply that the features, elements, and / or conditions are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic for determining whether or not those features, elements, and / or conditions should be included in or implemented in any particular embodiment, with or without authorial input or prompting.

[0082] Any process descriptions, elements, or blocks in the flow diagrams described herein and / or depicted in the accompanying figures should be understood as potentially representing modules or segments. As will be appreciated by those skilled in the art, alternative implementations in which elements or functions may be omitted, performed in a different order than that shown or described, including substantially simultaneously or in reverse order, depending on the functionality involved, are included within the scope of the embodiments described herein.

[0083] It should be emphasized that many variations and modifications may be made to the above-described embodiments, and that these elements are to be understood as being among the other acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims.

[0084] The present invention has been described above with reference to specific embodiments. However, other embodiments than those described above are equally possible within the scope of the present invention. Method steps other than those described above may be provided within the scope of the present invention. Different features and steps of the invention may be combined in other combinations than those described. The scope of the present invention is limited only by the appended claims.

Claims

1. at least one radiation protection drape sized to at least partially cover the patient from near the area where the patient will receive radiation down to the patient's feet; A radiation protection shielding system comprising: the radiation protection drape comprises at least a first section and a second section, the first section being partitioned from the second section from a first edge of the radiation protection drape toward a second edge of the radiation protection drape; Radiation protection shielding system.

2. 2. The radiation protection shielding system of claim 1, wherein the first section is partitioned from the second section from the first edge to the second edge of the radiation protection drape and is separable from the second section.

3. 2. The radiation protection shielding system of claim 1, wherein the first section is partitioned from the second section from the first edge partially to the second edge, and the first section is partially separated from the second section.

4. 10. A radiation protection shielding system according to any preceding claim, wherein the first section has a level of radiation protection that varies across the first section.

5. 10. The radiation protection shielding system of any preceding claim, wherein the second section comprises a first portion and a second portion, the first portion and the second portion being separated along an edge of each of the first portion and the second portion, and optionally comprising fasteners for temporarily securing the first portion to the second portion and unlocking the first portion from the second portion.

6. 10. The radiation protection shielding system of any preceding claim, wherein the radiation protection drape comprises at least one fenestration for the patient's thigh, the fenestration being disposed along a divider of the first section and the second section.

7. The radiation protection shielding system of claim 6 , wherein the second edge is located at the fenestration, and the first section and the second section are partitioned from the first edge to the second edge.

8. 10. The radiation protection shielding system of any preceding claim, wherein the radiation protection drape comprises a third section separate from the first section and the second section and sized to partially cover a fenestrated area of ​​the radiation protection drape.

9. 10. The radiation protection shielding system of any preceding claim, comprising at least one fastening device, such as Velcro or a magnet, disposed at a location where the first section is separated from the second section.

10. 10. A radiation protection shielding system as described in any preceding claim, wherein the radiation protection drape is sized such that, when placed over a patient lying on a surgical table, it extends beyond the rim of the surgical table and toward the floor on at least one side of the surgical table, most preferably about 10 cm beyond the rim of the surgical table to cover said side of the patient when lying on the surgical table.

11. 13. The radiation protection shielding system of any preceding claim, further comprising at least one floor or ceiling mounted radiation shielding screen positioned between clinical staff and a radiation receiving area in the upper body portion of the patient.

12. 10. The radiation protection shielding system of any preceding claim, further comprising at least one floor or table mounted radiation protection drape section configured to cover at least a portion of an area below the operating table, such as being sized to cover at least one long side and / or one foot end side of the operating table.

13. 10. A radiation protection shielding system according to any preceding claim, wherein the radiation protection drape has a radiation protection level corresponding to 0.1 to 1 mm lead equivalent, most preferably 0.35 to 0.7 mm lead equivalent.

14. 10. A radiation protection shielding system according to any preceding claim, comprising a radiation protective suit.

15. 15. The radiation protection shielding system of claim 14, wherein the radiation protective garment comprises at least one panel sized to extend over at least the front of a wearer's torso, the panel having a radiation protection level of 0.05 to 0.35 mm lead equivalent.

16. 16. The radiation protection shielding system of claim 14 or 15, wherein the radiation protection drape and the radiation protection garment each comprise different radiation protection elements, preferably the radiation protection drape consisting primarily of antimony as an attenuating component and the radiation protection garment consisting primarily of bismuth and / or wolfram as an attenuating component.

17. 10. The radiation protection shielding system of any preceding claim, comprising a closure indicator disposed at an overlap between at least the first section and the second section.

18. 1. A method for covering a patient with a radiation protection shielding system during a medical intervention involving radiation with ionizing radiation, comprising: at least partially covering the patient with at least one radiation protective drape from adjacent an area where the patient will receive radiation down to the patient's feet; Including, the covering includes covering a first portion of the patient with at least a first section of the radiation protection drape and covering a second portion of the patient with a second section of the radiation protection drape, the first section being segmented from the second section from a first edge of the radiation protection drape toward a second edge of the radiation protection drape. method.

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