Medical device support device
The support device with a base and adjustable holding members addresses the issue of instrument instability, providing secure and efficient positioning of guidewires and catheters during minimally invasive procedures.
Patent Information
- Application Number
- JP2022528255
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-11-20
- Filing Date
- 2020-11-02
- Publication Date
- 2025-07-10
- Estimated Expiration
- 2040-11-02
AI Technical Summary
Existing methods for holding medical instruments like guidewires and catheters in place during minimally invasive procedures are unreliable, leading to potential movement and prolonged procedures, increasing patient and specialist risks.
A support device with a base, gripping system, and multiple holding members with slits of varying shapes and sizes to securely hold medical instruments, allowing for precise positioning and easy adjustment.
The device ensures stable placement of medical instruments, reducing procedural time and risk by preventing unwanted movement, enhancing the safety and efficiency of interventions.
Smart Images

Figure 0007705662000001 
Figure 0007705662000002 
Figure 0007705662000003
Abstract
Description
Technical Field
[0001] Cross - reference to Related Applications This application claims the benefit of European Patent Application No. 19 383 022.1, filed on November 20, 2019.
[0002] The present disclosure generally relates to devices for supporting medical instruments, and more particularly, to support devices for supporting long medical instruments such as guidewires and catheters.
Background Art
[0003] Today, the trend in the medical field is focused on the introduction of new technologies for better healthcare delivery to patients. Open surgery is not used as frequently, and minimally invasive procedures are currently supported by patients and physicians. Minimally invasive procedures offer potential advantages such as a lower risk of infection, shorter recovery times, less scarring, and less patient pain.
[0004] Minimally invasive procedures such as endovascular repair and angioplasty may involve various different instruments such as guidewires, catheters, balloons, and stents. Such procedures may use known techniques (Seldinger technique) to access veins or organs. In this technique, a needle is used to make a small puncture in the skin to access an artery, and a guidewire passes through the incision to reach any part of the human anatomical structure that requires examination or treatment (angioplasty, recanalization, stent implantation, etc.). The guidewire may first reach the treatment site. Thereafter, a treatment catheter, balloon catheter, or stent can be delivered to the treatment site by passing the guidewire through. The specialist uses imaging such as ultrasound or fluoroscopy (X-ray video) to guide the medical instrument to the treatment site. To enable the catheter to be inserted and reach the treatment site, a dilator or introducer can be used to make the skin incision large enough. It is also known to use a guiding catheter to guide further instruments.
[0005] Thus, the guidewire provides a passage to the treatment site of the hollow organ that the specialist uses to introduce other medical instruments. When the guidewire and / or other medical instruments are placed in position, they generally need to remain in position. Otherwise, the surgery may not be properly performed.
[0006] Holding the guidewire and / or other instruments in the desired position at the treatment site, or holding the guidewire in the desired position, is an important issue during such an intervention. However, there is always a risk of inadvertently moving the catheter or guidewire. If the correct position of the medical instrument is lost, the specialist must reposition the guidewire and / or other medical instruments in the surgical field (treatment site) to continue the surgical procedure. This can prolong the procedure and increase the risks for the patient and the specialist, such as the risk of higher exposure to X-rays due to prolonged use of anesthetic or especially fluoroscopy.
[0007] Currently, when performing an intervention, a specialist typically implements a method of using a layer of moist sterilized towels to fix a medical device in a predetermined position. The bulky layer of towels is difficult to control, thus making the device prone to movement and therefore resulting in an unreliable method.
[0008] In the prior art, devices for holding a guide wire, catheter, etc. in a predetermined position during an intervention have been proposed. In particular, Patent Document 1 refers to devices, systems, and methods for catheter and guide wire management in a surgical setting. Such devices include a holding member housing and a holding member mounted within the housing, and such a holding member can hold one or more guide wires, catheters, etc. These devices are quite complex and can be considered for intravascular procedures that require a number of medical devices.
[0009] Patent Document 2 refers to a device for loading a guide wire into a tubular device such as a catheter.
[0010] Therefore, there is still a need for a device that can hold a medical device and solve at least some of the aforementioned problems.
Prior Art Documents
Patent Documents
[0011]
Patent Document 1
Patent Document 2
Summary of the Invention
[0012] In a first aspect, there is provided an apparatus configured to support a long medical instrument. The apparatus comprises a base, a gripping system for fixing the base to a surgical towel, and at least two holding members disposed on the base and extending upwardly from the base. The holding members have slits configured to hold the long medical instrument, whereby the long medical instrument extends through the slits of the holding members and extends substantially along a first direction. A first holding member of the at least two holding members is disposed substantially behind the second holding member along the first direction.
[0013] The support device may be fixed in place by gripping a surgical towel. Preferably, the long medical instrument is fixed in place in the direction of the long instrument with the holding members providing holding support at two positions, before and after the long instrument. Alternatively, one of the holding members is used to hold one instrument, such as a catheter, and the other is used for another long medical instrument, such as a guide wire, with the catheter disposed around the guide wire. The two holding members allow one medical instrument to be moved or removed while leaving the other medical instrument firmly in place.
[0014] The surgical towel used herein may be understood to comprise any type of cloth or fabric, such as cotton, used in surgery, for example, to demarcate a treatment area. The surgical towel may be absorbent or impermeable and may be disposable or reusable.
[0015] In one example, the holding member of the device may comprise slits of different shapes. The slits of the holding member may comprise a first segment, a second segment, and a third segment, and the first segment may have a constant width. The width of the first segment may depend on the diameter range of the elongate medical instrument. The second segment may have a substantially V-shaped cross-section. The second segment may be formed from two surfaces that form an angle that may depend on the diameter range of the elongate medical instrument. Also, the third segment may have a circular or oval cross-section, and the dimensions of the cross-section may depend on the diameter of the medical instrument to be used. The different shapes of the slits can enhance versatility and enable the device to be used in many different types of interventions by holding elongate medical instruments of different dimensions.
[0016] The support device may comprise at least two holding members having slits with the same shape. On the other hand, in other examples, the device may comprise holding members in which at least one of the at least two holding members has a different shape and / or dimension than the other to receive different elongate medical instruments within each slit. In a further example, the support device may comprise a holding member with two or more slits for supporting two or more elongate instruments. Such a support device having holding members with different shapes and sizes of slits comprises a device used to fix a plurality of elongate medical instruments of different diameters in place. The different shapes of the slits result in a general-purpose medical instrument support device for supporting elongate medical instruments and thus enhance its usefulness.
[0017] In some examples, the holding member may be removably fixed to the base of the support device. Such a support device allows for the replacement of the holding member and facilitates the fixing of several different instruments (instruments of different types, shapes or sizes) that may be required during a surgical intervention. Maintaining the base that holds the surgical towel and changing only the holding member of the device facilitates the surgical intervention and contributes to a desirable shortening of the surgical time.
[0018] In other examples, at least two holding members may be single-use (i.e., disposable) to facilitate a quick intervention, and thus it is easier for the operator to remove the already used holding member and attach a new sterilized holding member without sterilizing the already used holding member.
[0019] In a further example, a support device is provided, in which case the gripping system for fixing it in place may be formed by an incision made on the base such that at least one channel is formed on the base substantially along a first axis, and this channel may have a sinusoidal shape to fix the device to the fabric. The channel may have an opening, in which case this opening may be located on the side of the device perpendicular to the first axis, and the channel may be formed alongside the holding member. The shape of such a channel enables the device to be fixed to a surgical towel or any other piece of fabric in an efficient manner and allows the operator to move the device along the towel as may be required to maintain the position of a long medical instrument within the surgical field. Thereby, a device with improved handling is provided, enabling the operator to perform a more accurate and efficient intervention.
[0020] In other examples, a support device is provided, in which case the gripping system may comprise two channels, which may optionally extend substantially along a first axis such that the holding member is positioned between the channels, and the orientation of these two channels may be arranged oppositely such that the openings of the two channels are located on different sides of the base, and the sides extend substantially perpendicular to the first axis. This provides a support device with an improved ergonomic form, thus enhancing its function and increasing its usefulness.
[0021] In some other examples, the base adjacent to the opening of the channel may comprise at least one portion with an increased roughness. The shape and surface texture of such a portion can improve the operation of the device by the operator, especially when such a device is wet during the intervention.
[0022] In some examples, the elongate medical device may be a guide wire and / or a catheter.
[0023] These and other features and advantages of the present disclosure will become apparent from the following description of specific examples when viewed in conjunction with the accompanying drawings and the appended claims.
Brief Description of the Drawings
[0024]
Figure 1a
Figure 1b
Figure 2a
Figure 2b
Figure 3a
Figure 3b
Figure 3c
Figure 4a
Figure 4b
Figure ac
Figure 4d
Figure 5
Figure 6
Figure 7
Figure 8
Figure 9a
Figure 9b
Figure 9c
Figure 10a
Figure 10b
Figure 11a
Figure 11b
Figure 12a
Figure 12b
Figure 12c
Figure 12d
Mode for Carrying Out the Invention
[0025] Figures 1a and 1b schematically show an isometric view and a top view of an example of a support device 100 for supporting a long medical instrument. The support device 100 includes a base 200, a gripping system 300, and two holding members 400. The base 200 in this example includes a flat portion 210 and a raised portion 220 located at the center of the flat portion 210.
[0026] In this particular example, the holding member 400 may be integrally formed with the base 200. As will be described in more detail below, the holding member serves to hold medical instruments such as, for example, guide wires or catheters. The support device may be fixed at a predetermined position on the operating table. The grasping system 300 may be used for that purpose as will be described similarly below. When the device is fixed to the operating table, the medical instruments held by the device (e.g., guide wires, catheters) can also be fixed at a predetermined position. Unwanted and unplanned movement of the medical instruments can be avoided.
[0027] The flat portion 210 of the base, particularly the base 200, as shown in FIG. 1a, may comprise one or more opening grooves 230 for inserting a guide wire and the grasping system 300. The groove 230 for inserting the guide wire is configured to receive medical instruments such as, for example, a guide wire 500 and a catheter 600 so as to facilitate the end of the guide wire passing through the open end of the catheter, that is, the groove 230 may be dimensioned and formed such that a medical professional can pass the guide wire through the open end of the catheter. The groove 230 may be integrally formed with the base 200 of the device 100. In this example, the groove 230 is shown to be formed between the grasping system and the holding member, near the central raised portion 220 of the base 200, particularly at the inflection point of the transition of the base from the flat portion to the raised portion. Accordingly, the side walls of the central raised portion may be used as a support in the guide wire insertion procedure.
[0028] The groove 230 may have a generally semi-circular cross-section with different radii and depths depending on the dimensions of the medical instrument. The radius of the groove 230 may substantially match the outer diameter of the medical instrument (catheter) having the maximum radius received by the groove, and the depth of the groove may be greater than the outer diameter of the catheter.
[0029] The gripping system 300 may be integrally formed with the base 200 of the device. In some examples, an opening 330 is provided at the edge of the base 200, and the opening extends inward into the base. Thus, a channel 320 can be formed that extends substantially along the length of the device. FIG. 1b shows a device in which the base 200 comprises two channels 320a, 320b of sinusoidal shape, each channel starting from opposite edges and extending in opposite directions. The sinusoidal shape facilitates the gripping of the surgical towel, which can be inserted through the edge opening and pushed into the channel so as to firmly penetrate into the channel. Thus, the support device can be fixed to the surgical towel that is wrapped around and / or adjacent to the patient. Thus, the position of the support device can be fixed. Therefore, the medical instrument fixed to the holding member is also fixed in a predetermined position. Further, if the operator of the device wants to change its position, such a sinusoidal shape allows for a relatively smooth slide of the device 100 relative to the surgical towel 700.
[0030] The gripping system in this example includes two channels that allow for the insertion of the surgical towel from both directions. Also, the gripping system may comprise portions 310a, 310b having surfaces with increased roughness to facilitate gripping by a user, such as a nurse or a doctor.
[0031] In one example, the support device may be configured to be reused. After the intervention, the device can be sterilized and prepared for the next intervention. In other examples, the device is single-use and is configured to be used only once.
[0032] The support device may be formed from one or more thermoplastic materials. Suitable thermoplastic materials include acrylic, ABS, nylon, PLA, polybenzimidazole, polycarbonate, polyethersulfone, polyoxymethylene, polyetheretherketone, polyetherimide, polyethylene, polyphenylene oxide, polyphenylene sulfide, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene fluoride, Teflon (registered trademark), any of their derivatives, and combinations thereof. Also, the support device may be formed from a thermosetting polymer. Suitable thermosetting polymers include polyester, polyurethane, polyurethane, vulcanized rubber, bakelite, duroplast, urea-formaldehyde, melamine, diallyl phthalate, epoxy resin, epoxy novolac resin, benzoxazine, polyimide, bismaleimide, cyanate ester, polycyanurate, furan resin, silicone resin, thiolite, vinyl, their derivatives, and combinations. Further, the support device may be formed from metals commonly used in the manufacture of medical devices. Suitable metals include stainless steel and titanium.
[0033] Fingers 340a, 340b may each include portions 310a, 310b having a higher roughness than the remainder of the base 200. This provides a support device 100 that can be easily gripped by an operator and further held and manipulated more accurately, especially when portions 310a, 310b are wet or accompanied by saline or body fluid during an intervention. The rough portions 310a, 310b may each be part of fingers 340a, 340b and are located near the openings 330a, 330b of the channels. The shape and surface texture of the above portions may be formed so that the device is easily held by the operator, thereby resulting in more efficient operation of the device.
[0034] As shown in FIGS. 3a and 3c, the support device 100 includes at least two holding members 410, 420. In particular, FIG. 3a shows an example in which the holding members are removably fixed to the base 200. The removable holding members 410, 420 may be placed by the user into the couplings 221, 222, in which case the couplings may be part of the raised portion 220 of the base 200. The holding members include corresponding connecting portions 417, 427 that connect the holding members 410, 420 to the base 200 by fixing the holding members 410, 420 to the couplings. In this particular example, the coupling between the holding members 410, 420 and the couplings 417, 427 is a male-female coupling. In this particular case, the holding members 410, 420 have male coupling portions and the base includes female coupling portions for receiving the holding members. Of course, other couplings, coupling portions, and connectors are also conceivable.
[0035] FIG. 3b shows the holding member 410 in more detail. The holding member 410 of this example includes surfaces 412, 413 that form an opening, a slit 411. The slit 411 is formed at the upper end of the holding member 410 for receiving medical instruments such as catheters, guide wires, etc. In this example, the slit 411 is shown as including three different segments 414, 415, 416, each segment having a different shape and size.
[0036] The slit 411 is shown as being composed of a first segment 414 having a small opening with a constant width. In particular, the surfaces 412, 413 of the slit 411 are formed parallel to each other along the first segment 414, thus forming an opening with a constant-width cross-section suitable for holding medical instruments that can be used during the intervention. Such a segment 414 may be closer to the connection point 417, i.e., at the bottom or lower segment of the slit 411. The first segment of the slit can be used in particular for holding long instruments having a minimum cross-section.
[0037] Above the first segment, a second segment 415 of the slit 411 is shown, where the surfaces 412, 413 form a generally V-shaped cross-section. The surfaces may form an angle suitable for receiving medical instruments of different diameters. Thus, a suitable angle may be selected according to the type of instrument to be held. By pushing the instrument downward into the slit, the medical instrument can be held. The appropriate angle may be 2° to 20°, specifically 3° to 15°. The V-shaped cross-section with a varying width of the cross-section enables the holding of elongated medical instruments of different cross-sections. When the medical instrument is relatively small, the medical instrument is not held along the second segment 415, but rather in the thinnest segment 414.
[0038] In this example, a third segment 416, which is another segment, is formed above the other two segments 415, 414. The third segment has a circular, elliptical, or somewhat CD-shaped cross-section formed by various curvatures that may be provided by the surfaces 412, 413. The circular or elliptical cross-section may be configured to hold the standard end of a catheter. The various different shapes within one slit 411 as shown in this example provide an apparatus with different holding effects on medical instruments and enable a plurality of different medical instruments of different sizes to fit into the slit of the holding member.
[0039] The slit may be configured to support medical devices such as guide wires, catheters, etc. Each medical device has different dimensions according to the intended use, for example, the type of intervention, and thus, by having different segments within the slit with different cross-sections, it becomes possible to hold the medical device required for any type of intervention. For example, commonly used guide wires may have different diameters, such as 0.038 inches, 0.035 inches, 0.018 inches, 0.014 inches. The guide wire may have a diameter in the range of 0.254 mm (0.010 inches) to 0.965 mm (0.038 inches), while the catheter may have a diameter in the range of, for example, 3 French gauge (1 mm) to 34 French gauge (11.33 mm) depending on the intended use. Other shapes and dimensions of the slit will be shown later.
[0040] The dimensions (thickness and / or angle and / or diameter) of the slit may be selected in relation to the medical device to be held. Also, other aspects may contribute to the holding efficiency of such a device. The holding member may be formed from a material that also contributes to the efficiency of the device, such as the use of a flexible rubber-like material, so as to hold the medical device without the need to exactly conform to the diameter of such an instrument.
[0041] In any of the embodiments disclosed herein, the slit or a part of the slit may be subjected to a specific treatment to increase roughness. For example, a local chemical etching treatment can be performed on the injection mold to locally provide a texture on the mold.
[0042] In any of the embodiments disclosed herein, one or more small grooves may be provided in the mold used for injection near the bottom of the slit. Such small grooves may result in small notches on the side walls of the slit of the support device. These notches can help hold the smallest guide wires. The grooves in the mold may be manufactured using EDM (electrical discharge machining).
[0043] A support device 100 comprising two removably fixed retaining members 410, 420 is shown in FIGS. 3a and 3c. As described above, the retaining members 410, 420 are mounted on the base 200 by fixing the connecting parts or connectors 417, 427 within the couplings or within the coupling recesses 221, 222, and the slits 411, 421 of the retaining members are configured to support a medical instrument. As shown in FIG. 3c, a medical instrument, such as a guide wire 500, is fixed within the slits of the retaining members 410, 420 at two points along its length and extends substantially along a first axis through the slits 411, 421, where in this case the retaining members are arranged substantially behind one another along such a first axis. In this example, it is clear that the first axis extends along the longitudinal length of the base. The form of the support device 100 comprising at least two retaining members that hold the medical instrument (in this case the guide wire 500) at two points provides a more robust holding of the medical instrument. The robust support of the medical instrument enables the operator to perform other tasks safely and effectively without the movement of the medical instrument. Thus, the support device 100 provides a safe and effective method for performing surgical interventions with medical instruments that enjoy the benefits of fixation in the surgical field.
[0044] The flexibility of the retaining member, in combination with different cross-sections of segments of the slit, enables the medical instrument support device to engage with elongate medical instruments of different dimensions. In this aspect, the retaining member may comprise a slit having one, two or three segments, where each segment may have a different shaped cross-section. FIGS. 4a-4d show retaining members having slits of different shapes.
[0045] Figure 4a shows a holding member 430 having a slit 431 with a constant cross-section. The slit 431 is formed by two surfaces 432, 433 parallel to each other, thereby forming a cross-section with a constant width. The width of such a slit may be selected in relation to the different diameters of medical instruments used during the intervention. For example, the material of the holding member, such as an elastic, resilient, or flexible rubber-like material, can contribute to the support of medical instruments of different diameters and can provide a holding member that can be implemented for instruments of a wide range of diameters. Similar materials can be used for the holding members shown in Figures 4b to 4d.
[0046] A holding member 440 with a slit 441 is shown in Figure 4b. In this example, the slit comprises two segments 444, 445 having two different cross-sectional shapes. The first segment 444 has a small cross-section with a constant width as shown in Figure 4a. Above the first segment, the second segment 445 is formed by two surfaces 442, 443 that form an angle suitable for receiving medical instruments of different diameters, as also described in Figure 3b.
[0047] Figure 4c shows another example of a holding member 450, in which case the slit 451 of such a holding member also comprises two segments. The first segment 454 has a small cross-section with a constant width as shown in Figure 4a, but above the first segment, another segment 456 is formed. Such a segment comprises a substantially O-shaped cross-section formed by surfaces 452, 453, as also described in Figure 3b. The O-shaped segment may have a diameter selected based on the diameter of the medical instrument. Other aspects (materials, sizes, dimensions) of such slits can be the same as the various examples described above.
[0048] Yet another example of the retaining member 460 is given in FIG. 4d. The retaining member 460 of this example has two slits 461a, 461b arranged adjacent to each other. In this case, the two slits together comprise three different segments as shown in FIG. 3b, but with different configurations. That is, slit 461a comprises segments 464, 465 with the configuration shown in FIG. 4b, and slit 461b comprises an O-shaped segment 466. The retaining member 460 has larger dimensions than the other retaining members described above. This configuration allows two or more elongate instruments to be engaged with the device simultaneously.
[0049] The foregoing figures show retaining members with various slits having segments with different cross-sectional shapes and thus provide a device that can be implemented with a plurality of medical instruments of different diameters. The foregoing device comprises at least two retaining members having slits with the same shape, although other alternative devices are conceivable.
[0050] FIG. 5 shows a support device 100 with a base 200 and a gripping system 300 integrally formed with the base 200. The device 100 also comprises two removably fixed retaining members 410, 460, where in this case the retaining member 410 comprises a slit 411 different from the slits 461a, 460b of the retaining member 461. In particular, the retaining member 410 has a slit 411 as described in FIG. 3b, while the slits 461a, 460b of the retaining member 461 are formed like the retaining member shown in FIG. 4d. The use of such retaining members makes the device 100 a versatile device for supporting elongate medical instruments of different dimensions and thus enhances the usefulness of the device 100. In this example, the retaining members 410, 460, particularly the retaining member 460, can support a plurality of elongate medical instruments due to the plurality of positions available for receiving such instruments. Another combination of different slits on the retaining members can also be used for the device 100. Such retaining members may be formed from one or more materials that contribute to the efficiency of the device as described above.
[0051] FIG. 6 shows the Seldinger technique for accessing an organ or vein. Another technique is known, and the Seldinger technique is merely shown as an example of a way in which a medical professional can gain access to an organ such as a vein. A medical professional performs a puncture using a needle 20 to access, for example, a vein 21 (or other hollow organ) (step A), and a guide wire 22 passes through the hollow needle and the skin puncture (step B). Next, the needle is withdrawn with the guide wire 22 remaining inside the vein or hollow organ (step C). A surgical blade may be used to enlarge the skin incision so that a catheter can also reach the vein (step D). The use of introducer catheters and dilators is known. The guide wire may be steered through the patient's vasculature to reach the treatment site. A catheter (balloon catheter, stent, treatment catheter, or others) can be delivered to the treatment site by passing over the guide wire to enable investigation or treatment at the selected site. Thereafter, the guide wire can be withdrawn (step E). In other interventions, the guide wire can remain in place. Depending on the intervention, multiple catheters can be used, these catheters can be withdrawn, and then subsequent catheters can be introduced and guided again by the guide wire.
[0052] For various interventions, as already discussed, it may be important to maintain the positions of the guide wire and various catheters in place.
[0053] FIGS. 7-9 show different implementations of an apparatus 100 for holding at least a long medical instrument, such as a catheter 600 and / or a guide wire 500, when different long medical instruments can be used during an intervention. Only some implementations will be described, but other implementations are also possible. The apparatus 100 includes a base 200, a gripping system 300 for fixing the apparatus to a cloth, such as a surgical towel, and at least two holding members 410, 420 disposed on the base 200 and extending upward from the base. In FIG. 7, the guide wire is held by two holding members arranged front and back.
[0054] As shown in FIG. 8, in other interventions or at different instants of the same intervention, a catheter 600 disposed around the guide wire 500 may be supported by the device 100. The catheter 600 includes a proximal body 610 and an insertion tube 620 configured to reach a site in the patient's body that needs to be inserted and treated. The body 610 of the catheter includes a hub 611, the hub 611 further includes a neck 612, and the neck 612 has a standardized diameter. Catheters used in daily practice for intervention procedures have necks 612 with the same diameter. Thus, the device 100 having the holding members 410, 420 may be suitable for holding such catheters. In this example, in order to hold the neck 612 of the catheter 600 in the device 100, holding members 410, 420 with slits 411, 421 comprising at least third generally circular or generally O-shaped segments 416, 426 (such as those shown in FIG. 3b) are implemented. In this example, the catheter 600 is gripped at two points along its length such that the neck 612 of the catheter is fixed within the slit 411 of the holding member 410 and the tip of the insertion tube 620 is fixed within the slit 421 of the holding member 420.
[0055] Most catheters used in interventions have insertion tubes whose diameters are in the range of, for example, 3 to 34 French gauge depending on their intended use.
[0056] Further, as shown in FIG. 9a, the support device 100 may be used to hold the guide wire 500 and the catheter 600. In this example, the guide wire 500 and the catheter 600 are held by the device 100 by fixing the guide wire 500 to the slit 411 of the holding member 410 and by fixing the catheter 600 to the slit 421 of the holding member 420. The catheter is fixed within the slit 421 by fixing the neck 612 of the catheter 600 as described in FIG. 8, and the guide wire is fixed within the slit 411 of the holding member 410 of the device 100 as described in FIG. 7. The operator can place the guide wire 500 and the catheter 600 in the slits and then push such instruments down into the slits to fix them. This implementation 100 provides an efficient way of holding a pair of elongate medical instruments, where one instrument is inserted through the other, and as a result, rather than holding the medical instruments in place, it makes it easier for the operator to perform other aspects of the intervention, thereby making an important contribution of such a device to the overall intervention process.
[0057] In another method, the guide wire 500 and the catheter 600 are held on the device 100 by placing the guide wire 500 in the slit 411 and by fixing the catheter 600 to the slit 421 of the holding member 420. The catheter is fixed within the slit 421 by fixing the neck 612 of the catheter 600 as described in FIG. 8. However, in this example, the guide wire 500 is not fixed to the first segment 414 of the slit 411 and passes through the third O-shaped segment 416 of the slit 411 without being strongly fastened. Such an assembly facilitates the replacement of the guide wire from the catheter 600 according to the intervention procedure, with the catheter fixed in the slit 421 (FIG. 9c). Once such replacement of the guide wire is complete, the operator 1200 can re-fix the guide wire to the slit 411, particularly to the segment 414 of the slit, as shown in FIG. 9a.
[0058] Figures 10a and 10b show a further example of the support device 100. In this example, one of the holding members is different from the holding members shown previously for the other support devices 100. The holding member of this example may be removably fixed to the base 200. The removable holding member 470 may be placed by the user within the coupling 222, which may be part of the raised portion 220 of the base 200. The holding member 470 comprises a corresponding connector 472 that mates with the coupling 222. In this particular example, the attachment between the holding member 470 and the coupling 222 is a male-female coupling. In any of the illustrated examples, the holding member 470 may be snap-fitted to the coupling 220.
[0059] The holding member 470 further has a base, on which a plurality of pins 476 are provided. A thin and long medical device can be held between the pins 476. One or more rows of pins 476 may be provided to form a plurality of adjacent holding members. In this particular example, the holding member has a brush-like or comb-like appearance with multiple rows of pins arranged in front and back.
[0060] Figure 10b schematically shows how the guide wire 500 can be held between the pins 476. The guide wire 500 may be used in an intervention to guide a catheter 600. In the other holding member 410, the neck 612 at the proximal end of the catheter 600 is held in the situation of Figure 10b.
[0061] Figures 11a and 11b show yet another example of the support device 100 with another gripping system 300. In the illustrated example, the surgical towel 700 may be gripped and fixed between the wing 360 and the base 200. The wing 360 can rotate relative to the base 200, specifically relative to the central portion. The wing may have elasticity and / or may be spring-loaded. In the illustrated example, two wings 360 are provided on a single support device 100. In the initial set position, the wing may press against the base 200, but the user can open the wing to sandwich the surgical towel between the base 200 and the wing 360. In the illustrated example, the device includes one wing on each side of the holding member. In another example, a single wing 360 may be used, or multiple smaller wings may be used on one or both sides of the holding member.
[0062] In still other non-illustrated examples, a gripping system may be provided in which the finger 340 (such as in FIG. 2) may have a flat inner surface that can abut against the side surface of the base 200. Such a finger may have a certain degree of flexibility or may include a spring for contacting the finger with the base. The user can open the finger and introduce a part of the surgical towel between the finger and the base. Then, the finger can clamp the surgical towel.
[0063] In any of the examples disclosed herein, the base of the support device may be substantially rectangular. The length of the support device in the example may be 5 to 20 cm. Specifically, the support device may have a length of 7 to 15 cm. More specifically, the support device may have a length of 8 to 12 cm. The width of the support device in the example may be 5 to 15 cm. Specifically, the support device may have a width of 7 to 12 cm. More specifically, the support device may have a width of 6 to 9 cm. The height of the support device may be 1 to 10 cm. Specifically, the height of the support device may be 3 to 7 cm. In one particular example, the support device has a length of 8 to 12 cm, a width of 6 to 9 cm, and a height of 3 to 7 cm.
[0064] Figures 12a to 12d schematically show yet another example of a support device. The support device 1000 shown in FIG. 12 includes a plurality of sets 400A, 400B, 400C, 400D of holding members. Each set of the holding members 400A to 400D in this example includes a first holding member that is disposed substantially behind a second holding member along a first direction. In this particular example, the support device 1000 includes four sets of holding members.
[0065] In intravascular procedures performed using a guide and a catheter, increasingly complex procedures have been developed that simultaneously use two or more guides through a vascular access. Vascular access is the entry point for a guide, catheter, or other form of a specific medical device that is introduced into the body via a system called an introducer or sheath, and the system enables these devices to be held in a stable manner within a blood vessel (artery or vein).
[0066] Procedures for implanting fenestrated endoproteases require continuous catheterization of multiple blood vessels, for example at least three to four blood vessels, for their implantation and require stabilization for a certain period, for example 30 minutes or more. The actual time depends on the rate of catheterization and the implantation of the branches.
[0067] Specifically, the endoprotease system can treat and / or access the aorta, the superior mesenteric artery, the two renal arteries (left and right), and the celiac trunk. These guides are usually introduced from the same port or access site or introducer (at the femoral or axillary level) where great care must be maintained as the manipulation must be very precise and sudden movements that cause loss of position must be avoided.
[0068] In order to prevent the correct position of the guide from being lost when the guide is inserted into the catheter, it is important that each of the guide and / or the catheter can be stabilized and maintained in its position. With the support device 1000, accurate fixation of four guides or guide / catheter combinations simultaneously can be ensured. In the illustrated example, the base 200 includes identification marks or letters for each guide to facilitate control of the exact position of each guide.
[0069] In this example, CT indicates the celiac trunk, SM indicates the superior mesenteric artery, RR indicates the right kidney, and LR indicates the left kidney. It is obvious that these letters and displays can be changed for different applications. In another example, for instance, two or three guides or guide / catheter combinations can be used, and the support device 1000 can be adapted to specific requirements or interventions.
[0070] Referring to FIG. 12a, the support device 1000 includes four sets of holding members. Each of the sets 400A to 400D includes first and second holding members arranged front and back so that a long medical device can be clamped or otherwise fixed in a predetermined position along two different parts of the same medical device.
[0071] The set 400A in this example is intended to fix a long medical device accessing the celiac trunk in a fixed position. The guide wire 500 is fixed to both holding members arranged front and back. The guide wire 510 is fixed to two different parts of the guide wire by the set 400B of holding members. The guide wire 510 in this example can be used to access and / or treat the superior mesenteric artery. Similarly, the guide wires 520, 530 used to treat and / or access the right renal artery and the left renal artery respectively are fixed in a fixed position by the sets 400C, 400D of holding members.
[0072] Similar to the previous example, the support device 100 can include a gripping system 300 for fixing the base 200 to a surgical towel.
[0073] As shown in FIG. 12b, the support device 1000 may include one or more grooves 230 configured for inserting a guide wire. The tube of the catheter 600 may be disposed within the groove 230, and the guide wire 500 may also be disposed within the groove 230. Using the groove 230, the guide wire 500 can be pushed towards the catheter 600 and introduced into the catheter. Only one groove 230 for inserting a guide wire is shown on the side of the support device 100 between the holding member 400D and the gripping system 300. Similar grooves may be incorporated on the opposite side of the support device 100, i.e., between the holding member 400A and the gripping system 300.
[0074] FIGS. 12c and 12d schematically show a method by which a catheter can be fixed to a first set of the set of holding members 400A, and a guide wire 500 can be fixed to a second set of the same set of holding members 400A. The catheter 600 includes a proximal body 610 and an insertion tube 620 configured to reach a site that needs to be inserted into a patient's body for treatment. The body 610 of the catheter includes a hub 611, the hub 611 further includes a neck 612, and the neck 612 has a standardized diameter. The neck 612 may be fixed to the holding member 400A.
[0075] As shown in FIG. 12c, during the intervention, the catheter may remain fixed in position by the clamping force of the first holding member 400A. At the same time, the guide wire can be repositioned and moved relative to the catheter. A medical professional can remove the guide wire from the support device and reposition and fix the guide wire 500 to a second set of the set of holding members 400A (as shown in FIG. 12d).
[0076] To complete, some aspects of the present disclosure are set forth in the following numbered paragraphs. Paragraph 1. In a support device for supporting a long medical instrument, a base, a gripping system for fixing the base to a surgical towel, At least two holding members disposed on a base and extending upward from the base, the holding members having slits configured to support a long medical instrument, whereby the long medical instrument passes through the slits of the holding members and extends substantially along a first direction, and a first holding member among the at least two holding members is disposed substantially behind a second holding member among the holding members along the first direction, the at least two holding members; A support device comprising the same. Item 2. The support device according to Item 1, wherein the holding member is integrally formed with the base. Item 3. The support device according to Item 1, wherein the holding member or a part of the holding member is detachably fixed to the base. Item 4. The support device according to Item 3, wherein the holding member is configured to be single-use. Item 5. The support device according to Item 3 or 4, wherein the holding member is formed of a first material, the base is formed of a second material, and the first material is different from the second material. Item 6. The support device according to any one of Items 1 to 5, comprising two or more sets of holding members, each set of holding members comprising a first holding member disposed substantially behind a second holding member along a first direction. Item 7. The support device according to Item 6, comprising four sets of holding members. Item 8. The support device according to Item 6 or 7, wherein the base comprises one or more identification marks for indicating that the long medical instrument is in a position within one or more sets of holding members. Item 9. The slits of one or more holding members comprise a first segment and a second segment, The first segment is located below the second segment, The first segment is narrower than the second segment, The support device according to any one of Items 1 to 8. Item 10. The support device according to Item 9, wherein the first segment has a substantially constant width. Item 10. The support device according to Item 9, wherein the second segment has a substantially V-shaped cross section. Item 11. The support device according to Item 10, wherein the angle between a first surface and a second surface forming the second segment is 2° to 20°. Item 12. The support device according to any one of Items 8 to 10, wherein the slit includes a third segment, and the second segment is positioned below the third segment. Item 13. The support device according to Item 11, wherein the third segment has a circular or substantially elliptical cross-section. Item 14. The support device according to Item 9, wherein the second segment has a circular or substantially elliptical cross-section. Item 15. The support device according to any one of Items 1 to 14, wherein the first holding member has a shape and / or dimensions different from those of the second holding member. Item 16. The support device according to any one of Items 1 to 15, wherein the gripping system is formed by a first opening in the base that extends substantially along a first direction from a first edge of the base. Item 17. The support device according to Item 16, wherein the opening is substantially sinusoidal. Item 18. The support device according to Item 16 or 17, further comprising a second opening that extends from a second edge of the base opposite the first edge and extends along the first direction. Item 19. The support device according to any one of Items 1 to 18, wherein the base has a portion with increased roughness for gripping, and optionally, the portion with increased roughness. Item 20. The support device according to any one of Items 1 to 19, wherein the base includes one or more grooves configured for inserting a guide wire. Item 21. The support device according to Item 20, wherein one or more grooves for inserting a guide wire are formed between the gripping system and the holding member and extend substantially along the first direction. Item 22. The support device according to any one of Items 1 to 21, wherein the elongated medical instrument is a guide wire and / or a catheter. Item 23. The support device according to any one of Items 1 to 22, wherein the support device is configured to be sterilized by multiple uses. Item 24. The support device according to Item 23, wherein the support device is formed from stainless steel. Item 25. The support device according to any one of Items 1 to 24, wherein the device is configured to be single-use. Item 26. The support device according to Item 25, wherein the device is formed from a polymer. The apparatus according to any one of items 1 to 26, wherein the holding member is configured to receive a long medical instrument having a diameter in the range of 0.254 mm to 11.3 mm.
[0077] Although only some examples have been disclosed in this specification, other alternatives, modifications, uses, and / or their equivalents may be contemplated. Therefore, the scope of the present disclosure should not be limited by specific examples, but should be determined only by reading the following claims fairly.
Claims
1. In a support device for supporting a long medical instrument, a base, a gripping system for fixing the base to a surgical towel, at least two holding members disposed on the base and extending upward from the base, the holding members having slits configured to support the long medical instrument, whereby the long medical instrument extends through the slits of the holding members and extends substantially along a first direction, a first holding member among the at least two holding members being disposed substantially behind a second holding member among the holding members along the first direction, the slits of the holding members comprising a first segment having a substantially constant width, a second segment having a substantially V-shaped cross section, and a third segment having a substantially circular or elliptical cross section, the first segment being located below the second segment, the first segment being narrower than the second segment, and the second segment being located below the third segment, at least two holding members; A support device comprising the same.
2. The support device according to claim 1, wherein the holding member is integrally formed with the base.
3. The support device according to claim 1, wherein the holding member or a part of the holding member is detachably fixed to the base.
4. The support device according to claim 3, wherein the holding member is formed of a first material, the base is formed of a second material, and the first material is different from the second material.
5. The support device according to any one of claims 1 to 4, wherein the first holding member has a different shape and / or different dimensions from the second holding member.
6. The support device according to any one of claims 1 to 5, wherein the gripping system is formed by a first opening of the base extending substantially along the first direction from a first edge of the base.
7. The support device according to claim 6, wherein the opening is substantially sinusoidal.
8. The support device according to claim 6 or 7, further comprising a second opening extending from a second edge of the base opposite the first edge and extending along the first direction.
9. The support device according to any one of claims 1 to 8, comprising two or more sets of holding members, each set of holding members comprising a first holding member disposed substantially behind the second holding member along said first direction.
10. The support device according to any one of claims 1 to 9, wherein the elongate medical instrument is a guide wire and / or a catheter.
11. The device according to any one of claims 1 to 10, wherein the holding member is configured to receive the elongate medical instrument having a diameter in the range of 0.254 mm to 11.3 mm.
Citation Information
Patent Citations
Guidewire / Catheter Management Device
JP2011527609A
Retaining member
JP3188566U
Catheter accessory devices and methods of use
US20020177869A1
Patient medical tubing anchor and method
US20050182368A1
Medical tubing holder
US4606735A