NEEDLE MAGNETIZER
Patent Information
- Authority / Receiving Office
- MX · MX
- Patent Type
- Patents
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2019-10-03
- Publication Date
- 2026-06-12
Smart Images
Figure MX435107B0
Abstract
Description
NEEDLE MAGNETIZER TECHNICAL FIELD The aspects of this description refer to a device capable of housing and magnetizing tissue-penetrating medical devices, e.g., needles, of various lengths with and without a sheath covering part or all of the tissue-penetrating medical device. BACKGROUND Traditionally, medical professionals have not been able to visually observe the penetration of an invasive medical device, such as a needle or catheter tube, through the epithelial tissue to reach the vein during needle or catheter insertion. For this reason, clinicians must rely on their firsthand experience with needle insertion combined with their sense of touch to accurately identify the vein's location. This can be challenging when accessing a small vein deep beneath the skin, increasing the risk of excessive pain and / or injury to the patient. Similar challenges exist when inserting other invasive medical devices, such as probes, catheters, introducer needles, stylets, scalpels, and probes, regarding the inability to accurately visualize the device's location. Procedure guidance systems utilize a combination of ultrasound and magnetic technologies to provide visualization of subdermal anatomy and device positioning in both in-plane and out-of-plane orientations. Magnetized needles have been used to guide the insertion of needles and catheters in conjunction with ultrasound. This combination of ultrasound and magnetic methods also allows for projecting or anticipating the position of the insertion device relative to the patient's anatomy, thereby improving the likelihood of successfully reaching the vessels and completing the invasive procedure. The technology available today requires the clinician to manually magnetize the needle in a disposable magnetizer after removing it from a needle sheath just before use. Using the needle sheath while magnetizing the needle helps eliminate accidental damage to the needle tip while maintaining device sterility. However, the presence of the needle sheath presents a dilemma because, in most cases, clinicians cannot see the needle tip or the length of the needle to be magnetized. This strategy can lead to needle tip damage, microbial contamination, and / or a lack of consistency in the length of the magnetized section of the needle. Needle damage may occur that is not apparent to the user, which can negatively impact the insertion process.Similarly, user-generated magnetization of a metallic cannula also has some inherent limitations and risks, as this strategy does not guarantee consistent magnetization. Variability in clinical procedures, such as insertion depth, speed of the process, and needle centering in the magnetizer, will result in varying degrees of magnetization. The section of the needle near the distal end that needs to be magnetized is the same regardless of the actual needle length. However, with a needle sheath on the metallic cannula, it is difficult for a practitioner to determine the needle insertion depth, as a single standard sheath is currently used to cover needles of various lengths. Therefore, visual confirmation of the needle insertion depth is necessary when the sheath is placed in a magnetizer. Given the significant risk of needle tip damage, the increased possibility of contamination, and the lack of consistent magnetization, a system that systematically magnetizes the needle without introducing the aforementioned additional risks would be advantageous. Furthermore, disposing of the magnetizer after each needle or catheter insertion is costly. Therefore, there is a need for a device that ensures consistent magnetization along the length of the magnetized section of a needle or catheter, with or without a sheath covering part or all of the tissue-penetrating medical device. COMPENDIUM A first aspect of the description relates to a sheath for magnetizing a tissue-penetrating medical device comprising a sleeve member having an open proximal end, a distal end, an inner surface, an outer surface, and a hollow body extending between the proximal and distal ends. The sleeve member forms a protective closure over a shaft of a tissue-penetrating medical device having a longitudinal axis. The open proximal end of the sleeve member provides a receiving space to accommodate at least the shaft of the tissue-penetrating medical device. The outer surface of the sleeve member has a graduated injection depth gauge to indicate the needle penetration depth when the sheath is placed in a magnetizer. The graduated injection depth gauge may be printed, engraved, inscribed, stamped, or etched onto an external surface of the sleeve member. In one or more of these forms, the graduated injection depth gauge is scaled for correlation with needle length. In one or more of the configurations, the cover is sterile. In one or more of the configurations, the cover is disposable. nza / nn / eznz / E / YiAi In one or more versions, the case can be made of plastic. A second aspect of the description refers to a sheath for magnetizing a tissue-penetrating medical device comprising an open proximal end, a distal end, and a cavity defining a device reception space. The cavity has an open proximal end and a distal tip for surrounding a tissue-penetrating device. The sheath has a first length L1 between the open proximal end and the distal tip of the cavity. The sheath has a second length L2 between the distal tip of the cavity and the distal end. The sheath has a third length L3 between the open proximal end and the distal end. In one or more modalities, the first length L1 is less than the third length L3. In one or more modalities, the second length L2 is less than the third length L3. In one or more modalities, the third length L3 is equal to the sum of the first L1 and the second length L2. In one or more modalities, the first length L1 is equal to the third length L3. A third aspect of the description refers to a sheath for magnetizing a tissue-penetrating medical device comprising a base segment having one or more magnets and a first central cavity; one or more movable segments having one or more magnets stacked in a vertical configuration on top of the base segment, where the segment(s) have a second central cavity; and a hinge having a vertical axis not in contact with the first and second cavities, where the hinge connects the movable segment(s) and the base segment. The movable segments may be rotatable, sliding, or stackable. In one or more modalities, the first central cavity and the second central cavity allow the movement of a tissue-penetrating medical device into the first central cavity and the second central cavity in a direction parallel to a longitudinal axis of the tissue-penetrating medical device. In one or more modalities, the first central cavity and the second central cavity allow movement of the axis of the tissue-penetrating medical device into and out of the receiving space. In one or more configurations, there are two or more magnets arranged in the base segment. In one or more configurations, there are two or more magnets arranged in each of the movable segment(s). In one or more configurations, the magnet(s) are fixed permanent magnets. A fourth aspect of the description refers to a magnetizer for magnetizing a tissue-penetrating medical device comprising an open proximal end, a distal end, a first side wall, a first sliding element having one or more first magnets slidably connected to the first side wall, a second side wall, a second sliding element having one or more second magnets slidably coupled to the second side wall, and a cavity formed between the first side wall, the second side wall and the distal end. In one or more configurations, the first man(s) are mounted on the first sliding element. In one or more configurations, the second man(s) are mounted on the second sliding element. In one or more modes, the first sliding element and / or the second sliding element can move in a direction parallel to an axis of the cavity. In one or more modalities, the first sliding element and / or the second sliding element include a contact surface that has a profile to receive the finger of a professional. In one or more modalities, the cavity is configured to accommodate a tissue-penetrating medical device. In one or more forms, the tissue penetrating medical device is a needle assembly, stylet, catheter, introducer needle, scalpel, or probe. In one or more modalities, the tissue penetrating medical device includes a needle assembly comprising a needle and shaft, and when the shaft is magnetized, the tissue penetrating medical device is configured for use in a procedure guidance system to locate and project a shaft position during an invasive medical procedure. In one or more configurations, the cavity is configured to accommodate a needle sheath. In one or more forms, the magnet(s) comprise a fixed permanent magnet. In one or more modes, the first sliding element can move along the first side wall. In one or more modes, the second sliding element can move along the second side wall. Another aspect of the present description relates to a sheath for magnetizing a tissue-penetrating medical device comprising a sleeve member having an open proximal end, a distal end, an inner surface, an outer surface, one or more physical stop elements disposed on the outer surface; and a hollow body extending between the proximal and distal ends to form a protective closure over a shaft of a tissue-penetrating medical device. In one or more embodiments, the physical stop(s) correspond to different needle lengths to indicate the needle penetration depth when the sheath is placed in a magnetizer. In one or more modalities, the physical stop(s) correspond to different needle gauges to indicate the depth of needle penetration when the sheath is placed in a magnetizer. nzQ / nn / Qznz / e / viAi BRIEF DESCRIPTION OF THE FIGURES Figure 1 shows a perspective view of one modality of a needle magnetizer of the present description; Figure 2A shows a perspective view of an alternative embodiment of a needle magnetizer of the present description; Figure 2B shows a perspective view of an alternative modality of a needle magnetizer shown in Figure 2A of the present description; Figure 2C shows a perspective view of an alternative embodiment of a needle magnetizer of the present description; Figure 2D shows a perspective view of an alternative modality of a needle magnetizer shown in Figure 2C of the present description; Figure 3A shows a perspective view of yet another alternative embodiment of a needle magnetizer of the present description; Figure 3B illustrates a cross-sectional view of the needle magnetizer shown in Figure 3A of the present description; and Figure 4 illustrates a cross-sectional view of yet another alternative embodiment of a needle magnetizer of the present description. DETAILED DESCRIPTION Before describing several exemplary modalities, it should be understood that the description provided is not limited to the construction details or process steps outlined below. The devices and methods described herein are capable of other modalities and can be implemented or carried out in various ways. In this description, a convention is followed where the distal end of the device is the end closest to the patient, and the proximal end is the end farthest from the patient and closest to the practitioner. The aspects described herein refer to an improved system that addresses the challenges of existing technology and systems for magnetizing a needle, such as a needle used with a peripheral intravenous (IV) catheter. These aspects also refer to an improved device and system that helps maintain the sterility of the tissue penetrator and prevents damage to the distal tip of the tissue penetrator during magnetization. Therefore, in one or more embodiments of this description, a tissue penetrator is magnetized with the sheath described herein placed on the tissue penetrator. The section of the tissue penetrator, for example, a needle, near the distal end to be magnetized is the same regardless of the actual length of the needle. One or more embodiments of this description relate to a needle magnetizer capable of accommodating needles of various lengths with a sheath of this description placed on the tissue penetrator. In an alternative embodiment, a needle magnetizer is capable of accommodating needles of various lengths without a sheath being placed on the tissue penetrator. According to one or more embodiments, the device and system of this description systematically magnetize needles of various lengths with a sheath of this description placed on the tissue penetrator. In one or more embodiments, a tissue penetrator is magnetized without a sheath placed on the tissue penetrator.In one or more of the modalities described herein, the devices and systems provide more precise control of the magnet's position relative to the device to be magnetized, resulting in a more consistent and predictable magnetic field applied to the invasive medical device. In one or more of the modalities, the devices and methods described herein do not create any additional risk of needle damage compared to existing magnetizing devices, nor do they create any additional risk of contamination compared to existing magnetizing devices. On the contrary, the devices, system, and methods described herein reduce the risk of needle damage and contamination compared to existing magnetizing devices. With regard to Figure 1, one aspect of the description refers to a sheath 10 for a tissue-penetrating medical device 80, wherein the sheath has a sleeve member 14 having a hollow body 20 having a distal end 21, an open proximal end 22, an inner surface 23, and an outer surface 24 to form a protective closure over a shaft of a tissue-penetrating medical device. In one or more embodiments, the hollow body 20 may be tubular or of any other suitable shape. In one or more modalities, the distal end 21 may be open. In one or more modalities, the distal end 21 may be closed. The sleeve 10 can be used with tissue-penetrating medical devices, e.g., needles, of various lengths. As shown in Figure 1, in one or more modalities, the outer surface 24 of the sleeve member 14 includes a graduated injection depth gauge 25 having one or more lines (26, 27, 28, 29) to indicate how far to insert the sleeve 10 into a magnetizer (not shown) for various desired needle magnetization lengths. In one or more nzQ / nn / cznz / e / YiAi modalities, multiple marks, e.g., lines (26, 27, 28, 29), can be placed on the sleeve 10, where each mark corresponds to a different needle length for use with the sleeve 10.For example, in one or more embodiments, as shown in Figure 1, if the sheath 10 were intended to cover tissue penetrating devices having four (4) different lengths, there would be four (4) lines (26, 27, 28, 29) on the outer surface 24 of the sleeve member 14 of the sheath 10. The distance from the distal end of the tissue penetrating devices, e.g., a needle, to the mark for the specified needle length is the same for all needle lengths with their corresponding marks, e.g., lines (26, 27, 28, 29). Thus, the length of the magnetized needle tip section will be the same if the mark on the needle sheath for the specified needle length is aligned with an element in a magnetizer. A tissue penetrating device is inserted into the sheath 10 through the opening 30 of the open proximal end 22.The sleeve 10 is then inserted into a magnetizer (not shown), and the user aligns the lines (26, 27, 28, 29) of the graduated injection depth gauge 25 with the desired needle magnetization length. In one or more modes, the lines (26, 27, 28, 29) of the graduated injection depth gauge 25 provide visual confirmation to the user by indicating the needle penetration depth when the sleeve is placed in a magnetizer. In one or more embodiments, the graduated injection depth gauge 25 may be printed on an external surface 24 of the sleeve member 14. In another embodiment, the graduated injection depth gauge may be printed, engraved, inscribed, stamped, or molded or formed onto an external surface 24 of the sleeve member 14 to assist the user in measuring the needle penetration depth. In one or more embodiments, the graduated injection depth gauge is scaled for correlation with the length of a needle. Typically, manufacturers use the same needle sheath for devices with different needle lengths and gauges. Therefore, the distances between the needle sheath tips and the needle vary depending on the needle length and the sheath design. However, manufacturers are aware of these distances, which are fixed for a specific needle length and sheath design. Therefore, a graduated or marked injection depth gauge on the needle sheath indicating the needle tip position or the desired length of the magnetized needle section would allow clinicians to insert the correct needle length into the magnetizer, thus overcoming the limitations of existing technology. Similarly, a needle sheath design with the same distance between the needle tip and the sheath tip would achieve the same result. A tissue penetrating medical device 80 may include a needle assembly comprising a needle housing 81 and a needle shaft 82 having a pointed distal tip 84. In one or more embodiments, the sleeve member 14 may be transparent to allow the shaft and cannula of the needle of a tissue penetrating medical device to be visible. The sleeve member 14 has a length L that covers the shaft of the tissue penetrating medical device, including the pointed distal tip, to prevent accidental needle punctures. The arrows shown in Figure 1 with respect to length "L" also show the longitudinal axis of a needle shaft. The open end 22 of the hollow body 20 provides a device receiving space 40 to receive at least the shaft 82 of the tissue penetrating medical device 80. The receiving space of device 40 is sized and shaped to allow movement of the tissue-penetrating medical device shaft into and out of the receiving space of device 40. In one embodiment, the receiving space of device 40 allows movement of the tissue-penetrating medical device shaft within the receiving space of device 40 in a motion parallel to the longitudinal axis of the tissue-penetrating medical device shaft. The needle cannula is magnetized when the needle cannula, with the sheath 10, is inserted into a separate magnetizer (not shown). In an alternative embodiment, the needle cannula is magnetized when the needle cannula, without the sheath 10, is inserted into a separate magnetizer (not shown).In one or more embodiments, a magnetizer consists of a cavity with at least one opening through which the needle can be inserted. The cavity and opening are large enough to accommodate the tissue penetrator medical device with its sheath, thereby ensuring the sterility and integrity of the tissue penetrator medical device. The magnetizer cavity may have openings at both ends to allow the tissue penetrator medical device, with its sheath, of varying lengths and widths, to be inserted into the magnetizer to a desired depth for magnetization. In an alternative embodiment, the magnetizer cavity may have openings at both ends to allow the tissue penetrator medical device, without its sheath, of varying lengths and widths, to be inserted into the magnetizer to a desired depth for magnetization. A magnetizer further consists of magnetizing means around the cavity, such as permanent magnets or electromagnets, or other magnetizing means. A section of the tissue penetrator medical device that is exposed to the magnetizing means is magnetized as the tissue penetrator medical device is inserted into and withdrawn from the magnetizer. In use, the user would insert the tissue penetrator medical device with sleeve 10 into the magnetizer until the graduated injection depth gauge 25 on the outer surface 24 of the sleeve member 14 is aligned with the top of the magnetizer. When the tissue penetrator medical device is withdrawn from the magnetizer, the desired section of the tissue penetrator medical device, e.g., the needle, would be magnetized.The graduated injection depth gauge 25 on the outer surface 24 of the sleeve member 14 can be located at different positions along the outer surface 24 depending on the length and / or gauge of the tissue-penetrating medical device, e.g., the needle. In one or more embodiments, the sleeve 10 is sterile. In one or more embodiments, the sleeve 10 is disposable. In one or more embodiments, the sleeve 10 is made of plastic. A second aspect of this description relates to one or more sheaths for tissue-penetrating medical devices, such that the sheath can be used for tissue-penetrating medical devices, e.g., needles, of different lengths. In one or more embodiments, each sheath 110 or 120 has a uniform length and is used with a tissue-penetrating device of varying lengths. One or more physical stopping elements 150 are arranged on the outer surface of the sheath 110 or 120. In one or more embodiments, one or more physical stopping elements 150 are molded onto the outer surface of the sheath 110 or 120. In one or more embodiments, the position of the physical stopping elements 150 arranged on the outer surface of the sheath 110 or 120 corresponds to different gauges or sizes of various tissue-penetrating medical devices to be used with the sheath 110 or 120.Therefore, the length or portion of the tissue penetrator device is magnetized when a user inserts the sheath 110 or 120 into a magnetizer until the physical stopping elements 150 arranged on the outer surface of the sheath 110 or 120, corresponding to the desired gauge or size of the tissue penetrator device, reach the top of the magnetizer. Thus, the magnetized length or portion of the tissue penetrator device depends on the length of the tissue penetrator device within the sheath 110 or 120. In one or more embodiments, one or more physical stopping elements are arranged on the inner surface of a magnetizer. In one or more embodiments, the position of the physical stopping elements 150 arranged on the inner surface of a magnetizer corresponds to different gauges or sizes of various tissue penetrator medical devices to be used with the sheath 110 or 120.Therefore, the length or part of the tissue penetrator device is magnetized when a user inserts the sheath 110 or 120 into a magnetizer until the physical stopping elements 150 arranged on the outer surface of the sheath 110 or 120 that correspond to the desired gauge or size of the tissue penetrator device reach the corresponding physical stop on the inner surface of a magnetizer. As shown in Figure 2A and Figure 2B, a second aspect of the present description refers to the sleeve 110 and sleeve 120 which are designed to have a uniform fixed length between the open proximal end (122,132) and the distal end (121,131) of the sleeve (110, n7Q / nn / Q7n7 / B / viAi 120) to surround a tissue penetrating medical device (160, 170). Therefore, the sheath 110 or 120 has a uniform length, which can accommodate a tissue penetrating device of varying lengths, e.g., L1 as shown in Figures 2A and 2B. A tissue penetrating medical device may include a needle assembly comprising a needle housing and a needle shaft having a pointed distal tip. The open proximal end 122 of the cavity 161 provides a device receiving space to receive at least the shaft of the tissue penetrating medical device (160, 170). With respect to Figures 2A and 2B, the length Li refers to the length between the open proximal end (122, 132) of the sheath (110, 120) and the distal tip (162, 172) of a tissue penetrating medical device (160,170). The length Li represents the length required to cover the shaft of a tissue-penetrating medical device, including the distal pointed tip, to prevent accidental needlestick injuries. With reference to Figures 2A and 2B, the length L2 refers to the length between the distal tip (162, 172) of a tissue-penetrating medical device (160, 170) and the distal end (121, 131) of the sheath (110, 120). In one or more embodiments, the sheath (110, 120) may be tubular or of any other suitable shape. With reference to Figures 2A and 2B, the length L3 refers to the length between the open proximal end (122, 132) of the sheath (110, 120) and the distal end (121, 131) of the sheath (110, 120). In one or more modalities, the distal end (121, 131) may be open. In one or more modalities, the distal end (121, 131) may be closed.When a sheath (110, 120) surrounds a tissue penetrating medical device (160, 170) and both are inserted into a magnetizer such that the distal end (121, 131) of the sheath (110, 120) comes into contact with the bottom of a cavity of a magnetizer or physical stopping elements 150 arranged on the outer surface of the sheath 110 or 120 that corresponds to the desired gauge or size of the tissue penetrating device reaching the corresponding physical stop on the inner surface of a magnetizer, a desired section of the tissue penetrating medical device (160, 170) of length L1 will be exposed to the magnetic field to be magnetized. The sheath (110, 120) is sized and shaped to allow movement of the axis of the tissue penetrating medical device (160, 170) into and out of the device's receiving space. In one embodiment, the sheath (110, 120) allows movement of the axis of the tissue penetrating medical device (160, 170) within the sheath (110, 120) in a motion parallel to the longitudinal axis of the tissue penetrating medical device. A metallic portion of the tissue penetrating medical device (160, 170) is magnetized when the sheath (110, 120) is inserted into a separate magnetizer. In an alternative embodiment, the metallic part of the tissue penetrator device is magnetized when the tissue penetrator device, without sheath (110, 120), is inserted into a separate magnetizer.The magnetizer consists of a cavity with at least one opening through which the sheath (110, 120) can be inserted. The cavity and opening of the magnetizer are large enough to accommodate the tissue penetrator medical device (160, 170) with the sheath (110, 120) to ensure the sterility and integrity of the tissue penetrator medical device (160, 170) and its distal tip (162, 172). The magnetizer may have openings at both ends to allow tissue penetrators of various lengths and sheaths 110 of various lengths (L3) to be inserted to the desired depth. In one or more configurations, the distal end (121, 131) is open. In one or more configurations, the distal end (121, 131) is closed. The magnetizer further comprises magnetizing means around the cavity, such as permanent magnets or electromagnets, or other magnetizing means. A section of the tissue penetrating medical device (160, 170) exposed to the magnetizing means is magnetized as the tissue penetrating medical device (160, 170) is inserted into and withdrawn from the magnetizer. The magnetizer may have openings at both ends to allow tissue penetrating medical devices (160, 170) of various lengths L1 and sheath 110 or sheath 120 of various lengths L3 to be inserted to the desired depth. In one or more embodiments, as shown in Figure 2A, length Li is less than length L3. In one or more embodiments, as shown in Figure 2A, length L2 is less than length L3. In one or more embodiments, as shown in Figure 2A, length L3 is approximately the sum of Li and length L2. In one or more embodiments, as shown in Figure 2B, length Li is approximately equal to length L3. In one or more embodiments, each of the physical stopping elements 150 arranged on the outer surface of the sheath 110 or 120 corresponding to the corresponding Li, L2, or L3 of a desired caliber or size of the tissue penetrator device. As shown in Figure 2C, in conjunction with Figure 2D, an alternative embodiment refers to sheath 110 and sheath 120, which are designed to have different fixed lengths between the distal tip 162 of a cavity 161 for surrounding a tissue penetrating medical device and the distal end 121 of sheath 110 or the distal tip 131 of sheath 120. Therefore, sheath 110 or 120 is used depending on the length of the tissue penetrating device. Thus, if the insertion depth of the sheathed tissue penetrating medical device in a magnetizer is the same, the resulting length of the magnetized section of the tissue penetrating medical device will also be the same for tissue penetrating medical devices, e.g., needles, of different lengths. With respect to Figure 2C, the length Li refers to the length between the open proximal end 122 of the sheath 110 and the distal end 262 of a cavity 260 for surrounding a tissue-penetrating medical device. In one or more embodiments, the distal end 121 of the sheath 110 may be open. In one or more embodiments, the distal end 121 of the sheath 110 may be closed. A tissue-penetrating medical device may include a needle assembly comprising a needle housing and a needle shaft having a pointed distal tip. The open proximal end 122 of cavity 161 provides a device receiving space to receive at least the shaft of the tissue-penetrating medical device. The length Li represents the length required to cover the shaft of a tissue-penetrating medical device, including the distal pointed tip, to prevent accidental needlestick injuries. With reference to Figure 2C, the length L2 refers to the length between the distal end 262 of a cavity 161 for surrounding a tissue-penetrating medical device and the distal end 121 of the sheath 110. In one or more embodiments, the cavity 260 may be tubular or of any other suitable shape. With reference to Figure 2C, the length L3 refers to the length between the open proximal end 122 of the sheath 110 and the distal end 121 of the sheath 110.When a sheath 110 surrounds a tissue penetrating medical device and both are inserted into a magnetizer such that the distal end 121 of the sheath 110 comes into contact with the bottom of a cavity of a magnetizer, a desired section of the tissue penetrating medical device of length Li will be exposed to the magnetic field to be magnetized. The cavity 260 is sized and shaped to allow movement of the tissue penetrator shaft into and out of the device's receiving space. In one embodiment, the cavity 260 allows movement of the tissue penetrator shaft within the cavity 260 in a motion parallel to the longitudinal axis of the tissue penetrator shaft. A metallic portion of the tissue penetrator is magnetized when the tissue penetrator, with the sheath 110, is inserted into a separate magnetizer. In an alternative embodiment, the metallic portion of the tissue penetrator is magnetized when the tissue penetrator, without the sheath 110, is inserted into a separate magnetizer. The magnetizer consists of a cavity with at least one opening through which the needle can be inserted.The magnetizer cavity and opening are large enough to accommodate the tissue penetrator device with its sheath, thus ensuring sterility and needle integrity. The magnetizer may have openings at both ends to allow tissue penetrators of various lengths and sheaths of various lengths to be inserted to the desired depth. The magnetizer also consists of magnetizing means around the cavity, such as permanent magnets or electromagnets, or other magnetizing means. A section of the needle nzo / nn / rznz / E / YiAi that is exposed to the magnetizing means is magnetized as the needle is withdrawn from the magnetizer. With respect to Figure 2D, the length Li refers to the length between the open proximal end 132 of the sheath 120 and the distal tip 172 of a cavity 270 for surrounding a tissue penetrating medical device. A tissue penetrating medical device (not shown) may include a needle assembly comprising a needle housing and a needle shaft having a pointed distal tip. The open proximal end 132 of the cavity 270 provides a device receiving space to accommodate at least the shaft of the tissue penetrating medical device. The length Li represents the length required to cover the shaft of a tissue-penetrating medical device, including the distal pointed tip, to prevent accidental needlestick injuries. With reference to Figure 2D, the length L2 refers to the length between the distal tip 272 of a cavity 270 for surrounding a tissue-penetrating medical device and the distal tip 131 of the sheath 120. In one or more embodiments, the cavity 270 may be tubular or of any other suitable shape. With reference to Figure 2D, the length L3 refers to the length between the open proximal end 132 of the sheath 120 and the distal tip 131 of the sheath 120.When a sheath 120 surrounds a tissue penetrating medical device and both are inserted into a magnetizer such that the distal tip 131 of the sheath 120 comes into contact with the bottom of a cavity of a magnetizer, a desired section of the tissue penetrating medical device of length Li will be exposed to the magnetic field to be magnetized. The cavity 270 is sized and shaped to allow movement of the tissue penetrator shaft into and out of the device's receiving space. In one embodiment, the cavity 270 allows movement of the tissue penetrator shaft within the cavity 270 in a motion parallel to the longitudinal axis of the tissue penetrator shaft. A metallic portion of the tissue penetrator is magnetized when the tissue penetrator, with the sheath 120, is inserted into a separate magnetizer. In an alternative embodiment, a metallic portion of the tissue penetrator is magnetized when the tissue penetrator, without the sheath 120, is inserted into a separate magnetizer. The magnetizer consists of a cavity with at least one opening through which the needle can be inserted.The magnetizer cavity and opening are large enough to accommodate the tissue penetrator device with its sheath, thus ensuring sterility and needle integrity. The magnetizer may have openings at both ends to allow tissue penetrators of various lengths and either the L3 sheath (110) or the L3 sheath (120) with various lengths to be inserted to the desired depth. In one or more modes, as shown in Figure 2C, the length Li is less than the length L3. In one or more modes, as shown in Figure 2C, the length L2 is less than the length L3. In one or more modes, as shown in Figure 20, the length L3 is approximately the sum of Li and the length L2. In one or more modes, as shown in Figure 2D, the length Li is approximately equal to the length L3. The magnetizer also consists of magnetizing means around the cavity, such as permanent magnets or electromagnets, or other magnetizing means. A section of the needle that is exposed to the magnetizing means is magnetized as the needle is withdrawn from the magnetizer. In one or more configurations, the 110 and 120 sheaths may be transparent to allow the shaft and cannula of a tissue-penetrating medical device needle to be visible. In alternative configurations, the 110 and 120 sheaths may be opaque. It is envisaged that, in one or more embodiments, an external surface of the 110 or 120 sleeve may have a graduated injection depth gauge or a mark to indicate the desired section of the needle to be magnetized when the needle and needle sleeve are inserted into a magnetizer. In one or more embodiments, the graduated injection depth gauge may be printed on an external surface of the 10 sleeve. In another embodiment, the graduated injection depth gauge may be printed, engraved, inscribed, stamped, or molded or formed onto an external surface of the 110 or 120 sleeve to assist the practitioner in measuring the needle penetration depth. In one or more embodiments, the graduated injection depth gauge is scaled for correlation with the length of a needle. In use, the user inserts the tissue penetrator medical device with either the 110 or 120 sheath into a magnetizer to magnetize a desired portion of the device. In one or more modalities, the lengths L1, L2, and / or L3 may vary depending on the length and / or gauge of the desired tissue penetrator medical device. The 110 or 120 sheath may have lines indicating the insertion depth for each needle length. The needle is inserted into a magnetizer with the sheath in place, making contact with the bottom of the magnetizer to achieve the desired magnetization length without any further action by the user. In one or more versions, the cover is sterile. In one or more versions, the cover is disposable. In one or more versions, the cover is made of plastic. A third aspect of the present description, as shown in Figure 3A and Figure 3B, refers to a magnetizer 300 having a base segment 310 having one or more magnets 320, and one or more movable segments (330, 340) stacked in a vertical configuration on top of the base segment 310. In one or more embodiments, the movable segments (330, 340) may be ring-shaped. ηζο / ηη / Γζηζ / Ε / γίΛΐ The base segment 310 and the movable segments (330, 340) have a central cavity 360. The movable segment(s) (330, 340) rotate or move about a hinge 370 having a vertical axis 380 that is not in contact with the cavity 360. In one or more embodiments, the movable segment(s) (330, 340) have one or more magnets 320. In one or more embodiments, the magnetizer 300 as shown in Figure 3A and Figure 3B can accommodate a needle sleeve of a uniform fixed length that can be used for needles of different lengths. Therefore, the insertion depth of the sleeve with respect to the bottom of the cavity 360 of the magnetizer 300 will remain the same for needles of various different lengths. The number of movable segments (330, 340) on the base segment 310 can be adjusted by moving the movable segments (330, 340) to correspond to the desired needle length surrounded by the sheath.In one or more modes, when magnetizing a needle of the shortest length, all movable segments (330, 340) are used on the base segment 310 to form the magnetization cavity 360. When magnetizing a needle of the longest length, only the base segment 310 is used to magnetize the needle, while the other movable segments (330, 340) are removed from their position. Therefore, the movement of the movable segments adjusts the distance between the bottom of the magnetization cavity 360 and the top of the magnetizer 300. To adjust the length of the magnetizer to fit a tissue penetrator device or sheath of various lengths, one or more of the movable segments (330, 340) can be moved or rotated about axis 380 so that the movable segment(s) (330, 340) are out of the way when tissue penetrator devices, e.g., needles, of different lengths are inserted into cavity 360 of the magnetizer 300 for magnetization. With respect to Figure 3A, the magnetizer 300, according to one embodiment of the present description, has a cavity 360 formed between multiples of two or more movable segments (330, 340) and the base segment 310, which are stacked and centered around a vertical axis 380. Each movable segment (330, 340) and base segment 310 has a central cavity 360 of sufficient size to receive a tissue-penetrating medical device, e.g., needles, of various lengths with a sheath covering part or all of the tissue-penetrating medical device. The cavity 360 of each movable segment (330, 340) and the base segment 310 can be arranged and aligned in a circular array concentric with the axis 380 such that a tissue-penetrating device can be inserted into the cavity 360. The cavity 360 is of sufficient size to receive a tissue-penetrating medical device, e.g.The device comprises needles of various lengths with a sheath covering part or all of the tissue-penetrating medical device. In one or more embodiments, the base segment 310 may have an open proximal end and an open distal end. In one or more embodiments, the base segment 310 may have an open proximal end and a closed distal end. In one or more embodiments, the base segment 310 may have a closed proximal end and an open distal end. In one or more embodiments, the movable segments (330, 340) may rotate about axis 380 and may move or rotate in opposite directions or in the same direction. Each movable segment (330, 340) may be integrated with one or more magnets 320. In one or more embodiments, the magnet 320 is a permanent magnet. Some of the features described above in this embodiment of the invention are for illustrative purposes and may vary in other embodiments of the invention.In one or more configurations, the number of segments, and their respective cavities, will depend on the dimensions, including size, shape, height, length, etc., of the desired tissue penetrator sheath or device to be magnetized by the magnetizer. Each of the movable segment(s) (330, 340) and the base segment 310 can be of different sizes, shapes, lengths, heights, diameters, radii, etc., depending on the desired tissue penetrator and / or the sheath to be inserted into the magnetizer, which is composed of one or more movable segments (330, 340) and the base segment 310. As shown in Figure 3A, the movable segments (330, 340) are supported on a base segment 310, which may be in the form of an upwardly extending vertical cylinder. Each movable segment (330, 340) has a centrally extending cylindrical cavity to accommodate a tissue-penetrating medical device, e.g., a needle, of various lengths with a sheath covering part or all of the tissue-penetrating medical device. Each segment may be coaxial with the base segment 310. A hinge 370 is attached to each movable segment (330, 340) to support the base segment 310 while simultaneously allowing movement or rotation of each movable segment (330, 340). In one or more configurations, each segment can be integrated with one or more magnets 320. In one or more configurations, the magnet 320 can be a permanent magnet. In one or more configurations, one or more segments can be moved or rotated around the vertical axis to vary the length of the cavity in which the tissue penetrator device is placed. Therefore, by moving one or more segments around the vertical axis, the length of the cavity can be adjusted to a desired length. Thus, the user can control the portion or length of the tissue penetrator device to be magnetized. For example, as shown in Figure 3B, the base segment 310 has a length L1, segment 330 has a length L2, and segment 340 has a length L3.Depending on the length of the sheath or tissue penetrator to be magnetized, one or more segments can be moved around the vertical axis to vary the length of the cavity in which the tissue penetrator is placed. In one or more configurations, the movement can be rotational or translational. For example, if the desired length of the sheath or tissue penetrator to be magnetized is Li, both segment 330 and segment 340 can be moved or rotated around the vertical axis to adjust the length of the cavity in which the tissue penetrator is placed to Li. For example, if the desired length of the sheath or tissue penetrator to be magnetized is U, segment 340 can be moved or rotated around the vertical axis to adjust the length of the cavity in which the tissue penetrator is placed to L1 (the sum of Li and L2).For example, if the desired length of the sheath or tissue penetrator to be magnetized is Ls, neither of the segments (340, 350) moves or rotates around the vertical axis; instead, segment 340 and segment 350 align with the base segment 310 to adjust the length of the cavity in which the tissue penetrator is placed to L5 (the sum of L1, L2, and L3). Therefore, the user can control the portion or length of the tissue penetrator to be magnetized. In one or more embodiments, the magnetizer 300 can be used with any sheath 110 or 120 described herein. In one or more embodiments, the sheath 110 or 120 may be of uniform length, have one or more physical stopping elements 150 arranged on its outer surface, and be used with a tissue penetrator of varying lengths. In one or more embodiments, one or more physical stopping elements 150 are molded onto the outer surface of the sheath 110 or 120. In one or more embodiments, the position of the physical stopping elements 150 arranged on the outer surface of the sheath 110 or 120 corresponds to different gauges or sizes of various tissue penetrator medical devices to be used with the sheath 110 or 120.Therefore, the length or portion of the tissue penetrator device that becomes magnetized when a user inserts the sheath 110 or 120 into a magnetizer 300 until the physical stopping elements 150 arranged on the outer surface of the sheath 110 or 120, corresponding to the desired gauge or size of the tissue penetrator device, reach the top of the magnetizer 300. Therefore, the length or portion of the tissue penetrator device that is magnetized depends on the length of the tissue penetrator device inside the sheath 110 or 120. The magnetizer 300 can be used as a single-use, disposable item, or it can be reused since the needle sheath remains in place during the magnetization stage. In other embodiments, the length Li of the base segment 310, L2 and L3 of the respective segments (330, 340), and the length L4 and Ls of the magnetizer 300 can be configured so that all or the desired portion of a shaft of the tissue-penetrating medical device can be magnetized. In other embodiments, the lengths Li, L2, L3, L4, and L5 can represent 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or any intermediate percentage of the length of the sheath or tissue-penetrating device to be magnetized. Figure 3B shows a cross-sectional view of a magnetizer 300 having one or more magnets 320 integrated into the side wall of the base segment and respective segments (330, 340) of the magnetizer 300. The magnet(s) 320 may be integrated into a slot. The magnet(s) 320 may be sized to slide into a slot or be held in place by a friction fit, or the magnet(s) 320 may be joined with an adhesive or other suitable means. Alternatively, one or more magnets 320 may be molded integrally into the side wall of the base segment 310 and the respective segments (330, 340) of the magnetizer 300. In one or more embodiments, the magnet may be a permanent magnet, electromagnets, or other magnetizing means. In one or more configurations, the 300 magnetizer allows you to change the position of the magnetic pole tip relative to the magnetizer cavity, particularly useful when the cavity contains only one opening. The top of the magnetizing medium can be moved closer to the bottom of the cavity when magnetizing a longer needle. A fourth aspect of the present description, as shown in Figure 4, refers to a magnetizer 400, having an open proximal end 402, a distal end 404, a first side wall 406, a first sliding element 410 having one or more first magnets 412 slidably connected to the first side wall 406, a second side wall 414, a second sliding element 418 having one or more second magnets 420 slidably coupled to the second side wall 414, and a cavity 422 formed between the first side wall 406, the second side wall 414, and the distal end 404. The first magnet(s) are mounted on the first sliding element 410. The second magnet(s) 420 are mounted on the second sliding element 418.The first sliding element 410 and the second sliding element 418 can be moved parallel to the axis of the cavity 422 to adjust the length of the magnetizer to magnetize a tissue penetrator device 500 or a sleeve 600 of various lengths that are inserted into the cavity 422 of the magnetizer 400, thus allowing adjustment of the distance between the bottom of the magnetizing cavity 422 and the top of the magnet (412 / 420).In one or more embodiments, the first side wall 406 may have a first slot 408, a first sliding element 410 having one or more first magnets 412, wherein the first sliding element 410 is slidably connected to the first slot 408, a second side wall 414 having a second slot 416, a second sliding element 418 having one or more second magnets 420, wherein the second sliding element 418 is slidably coupled to the second slot 416, and a cavity 422 formed between the first side wall 406, the second side wall 414, and the distal end 404. One or more of the modalities of the present description refer to a needle magnetizer capable of accommodating the tissue penetrator device 500 or the sheath 600 of various lengths. The cavity 422 is sized and shaped to allow movement of the tissue penetrator device 500 or sheath 600 in and out of the cavity 422. In one embodiment, the cavity 422 allows movement of the tissue penetrator device 500 or sheath 600 within the cavity 422 in a motion parallel to the longitudinal axis of the tissue penetrator medical device. The needle cannula is magnetized when the tissue penetrator device 500 or sheath 600 is placed in the cavity 422, and subsequently the first sliding element 410 and / or the second sliding element 418 are moved parallel to the axis of the cavity 422 to adjust the length of the magnetizer to magnetize a desired portion of the tissue penetrator device 500 or sheath 600 of various lengths that are inserted into the cavity 422 of the magnetizer 400.The magnetizer consists of a cavity with at least one open proximal end 402 through which the tissue penetrator device 500 or sheath 600 can be inserted. The cavity 422 and the open proximal end 402 are large enough to accommodate the tissue penetrator device 500 or sheath 600 of various dimensions and lengths, which are inserted into the cavity 422 of the magnetizer 400, thus ensuring the sterility and integrity of the tissue penetrator device. It is envisaged that, in one or more embodiments, the cavity 422 may have openings at both ends to allow needles and needle sheaths of various lengths to be inserted to the desired depth. The first sliding element 410 and / or the second sliding element 418 can be variably positioned along the length L of the sleeve 600 relative to the axis of the tissue penetrator 500 to allow the user to control the portion or length of the tissue penetrator 500 to be magnetized. The magnetizer 400 can be used as a single-use, disposable element, or it can be reused since the sleeve 600 remains in place during the magnetization stage. Therefore, the user can control the portion or length of the tissue penetrator 500 to be magnetized. The slider can be slidably moved along the length of the sleeve 600 through the first slot 408 and the second slot 416.In other embodiments, the length of the first slot 408 and the second slot 416 may be equal to the length L of the sheath 600 or of the tissue penetrator device 500 in such a way that the entire shaft of the tissue penetrator medical device 500 can be magnetized. In other embodiments, any desired part (e.g., 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or any intermediate value) of the length L of the penetrator medical device 500 can be magnetized. The magnet (412, 420) can be attached to the sliding elements (410, 418) with an adhesive or other suitable means. Alternatively, the magnets (412, 420) could be molded integrally into a sliding element (410, 418). The magnet (412, 420) may be sized to be slidably mounted within the first side wall (406) and / or the second side wall (414). In one or more embodiments, the magnet (412, 420) may be sized to be slidably mounted within the slot (408, nzQ / nn / cznz / e / YiAi) 416). In one or more forms, the magnet (412, 420) may be a permanent magnet, electromagnets, or other means of magnetization. It is envisaged that the first side wall 406 and / or the second side wall 414 may have a graduated injection depth gauge or a mark 430 to indicate the desired length or section of the needle to be magnetized when the needle and needle sheath are inserted into a magnetizer. In one or more embodiments, the graduated injection depth gauge may be printed on an external surface of the first side wall 406 and / or the second side wall 414. In another embodiment, the graduated injection depth gauge may be printed, engraved, inscribed, stamped, or molded or formed onto an external surface of the first side wall 406 and / or the second side wall 414 to assist the practitioner in measuring the needle penetration depth. In one or more embodiments, the graduated injection depth gauge is scaled for correlation with needle length. In one or more modalities, the first sliding element 410 and / or the second sliding element 418 include a contact surface that has a profile to accommodate a professional's finger. The first sliding element 410 and / or the second sliding element 418 can be configured to alternate in a direction parallel or perpendicular to the tissue penetrator device 500 or the sheath 600. The movement of the first sliding element 410 and / or the second sliding element 418 from a front end of the first side wall 406 to the rear end of the second side wall 414 can be achieved by applying pressure to the contact surface with the fingers 440 of the first sliding element 410 and / or the second sliding element 418. Figure 4 shows a tissue penetrating medical device 500, a sleeve 600 for magnetizing the shaft 134 of the tissue penetrating medical device 130. The sleeve 600 includes a sleeve member 602 having a hollow tubular body 604 with a distal end 606 and a proximal end (not shown) to form a protective closure over the shaft 608 of the tissue penetrating medical device 500. The sleeve member 602 has a length L to cover the shaft 608 of the tissue penetrating medical device 500. The shaft 608 has a length L2 and a distal tip 610. An open end (not shown) of the hollow tubular body 604 provides a receiving space to receive at least the shaft 608 of the tissue penetrating medical device 500. In one or more modalities, a single magnet can be used to magnetize the shaft 608, or more than two magnets can be used. In configurations using two magnets, the orientation of the magnetic fields of the two magnets can vary. One magnet may have its north and south poles aligned with the axis of the tissue penetrator device, while the second magnet may have its north and south poles off-axis or perpendicular to the axis of the tissue penetrator device. Alternatively, both magnets may have their north and south poles off-axis with the axis of the tissue penetrator device, or both magnets may have their north and south poles aligned with the axis of the tissue penetrator device. By removing the magnetizer 400, the tissue penetrator 500 medical device can now be used with a procedure guidance system that uses magnetic sensors as a means of measuring and predicting the location of the needle tip with respect to the target anatomy. In one or more configurations, the 400 magnetizer allows the position of the magnetic pole tip to be changed relative to the magnetizer cavity, particularly useful when the cavity contains only one opening. The top of the magnetizing medium can be repositioned closer to the bottom of the cavity when magnetizing a longer needle. In alternative embodiments, a needle sheath is provided with geometric dimensions that allow it to be placed inside existing needle magnetizing devices while covering the needle shaft. The distal end of the needle sheath can be used to limit the insertion depth by providing a stop that makes contact with the bottom of the needle magnetizing device. Alternatively, an element near the proximal portion of the needle sheath can be provided to limit the insertion depth by means of a stop at the proximal opening of the needle magnetizer. The sheaths described herein may have a variety of properties. In one or more embodiments, the sheaths are made of plastic. In one or more embodiments, the sheaths are sterile. In one or more embodiments, the sheaths are disposable. In other embodiments, the sheaths may be both sterile and disposable. A tissue-penetrating medical device can be a needle, catheter, introducer needle, stylet, dissertation device, or probe. In one modality, the tissue-penetrating medical device is a needle, which, when magnetized, can be used with a procedural guidance system to determine and project the needle's position during an invasive medical procedure. The tissue-penetrating medical device, according to one or more modalities, includes a magnetizable metallic material. In one specific modality, the magnetizable metallic material is stainless steel. The sheaths described herein may also be incorporated into a vascular access device comprising a catheter, a catheter adapter subassembly, and a needle subassembly including an introducer needle, a needle connector connected to the proximal end n7Q / nn / Q7n7 / e / viAi of the introducer needle, and a needle sheath according to any of the modalities described herein. The magnetizer described herein may also be used in conjunction with a vascular access device comprising a catheter, a catheter adapter subassembly, and a needle subassembly including an introducer needle. Another aspect of the description relates to a method for magnetizing a tissue-penetrating medical device. The modalities of the method include placing a shaft of a tissue-penetrating medical device in a sheath of the present description that includes a device receiving space, placing the sheath containing the tissue-penetrating medical device in a magnetizer, and removing the sheath with the tissue-penetrating medical device from the magnetizer to magnetize a desired portion of the tissue-penetrating medical device.Another embodiment of the method described herein includes placing a shaft of a tissue penetrating medical device in an available sheath having a device receiving space, positioning the sheath with the tissue penetrating medical device in a magnetizer described herein, and removing the sheath with the tissue penetrating medical device from the magnetizer described herein to magnetize a desired portion of the tissue penetrating medical device. References in this descriptive report to "a modality," "certain modalities," or "one or more modalities" mean that a particular element, structure, material, or characteristic described in relation to a modality is included in at least one modality of the description. Therefore, the appearance of expressions such as "in one or more modalities," "in certain modalities," or "in a modality" in various parts of this descriptive report does not necessarily refer to the same modality of the description. Furthermore, the particular elements, structures, materials, or characteristics may be combined in any appropriate manner within one or more modalities. Although the description provided herein is given with reference to particular embodiments, it is understood that these embodiments are merely illustrative of the principles and applications of this description. It will be evident to those skilled in the art that various modifications and variations of the method and apparatus described herein may be made without departing from the scope and spirit of the description. Therefore, this description is intended to include modifications and variations that fall within the scope of the appended claims and their equivalents.
Claims
1. A sleeve for magnetizing a tissue-penetrating medical device comprising: a sleeve member having an open proximal end, a distal end, an inner surface, an outer surface, and a hollow body extending between the proximal end and the distal end to form a protective closure over a shaft of a tissue-penetrating medical device having a longitudinal axis; an open end of the sleeve member providing a receiving space to receive at least the shaft of the tissue-penetrating medical device; the outer surface of the sleeve member having a graduated injection depth gauge to indicate the depth of needle penetration when the sleeve is placed in a magnetizer.
2. The sleeve of claim 1, wherein the graduated injection depth gauge is printed, engraved, inscribed, stamped or carved on an external surface of the sleeve member.
3. The sheath of claim 1, wherein the graduated injection depth gauge is scaled for correlation with the length of a needle.
4. The sheath of claim 1, wherein the sheath is sterile.
5. The cover of claim 1, wherein the cover is disposable.
6. The cover of claim 1, wherein the cover comprises plastic.
7. A sleeve for magnetizing a tissue-penetrating medical device comprising: a sleeve member having an open proximal end, a distal end, an inner surface, an outer surface, one or more physical stopping elements disposed on the outer surface; and a hollow body extending between the proximal end and the distal end to form a protective closure over a shaft of a tissue-penetrating medical device.
8. The sheath of claim 7, wherein the one or more physical stopping elements correspond to different needle lengths to indicate the needle penetration depth when the sheath is placed in a magnetizer.
9. The sheath of claim 7, wherein the one or more physical stopping elements correspond to different needle gauges to indicate the depth of needle penetration when the sheath is placed in a magnetizer.