MEDICAL INSTRUMENT SUPPORT DEVICE
20220273914 · 2022-09-01
Inventors
Cpc classification
A61M2025/09125
HUMAN NECESSITIES
International classification
Abstract
A device for supporting an elongated medical instrument that includes a base, a gripping system for securing the base to a surgical towel, and at least two retaining members disposed on the base and extending upwardly from the base. Each of the retaining members has a slit configured to support the medical instrument, such that the medical instrument extends through the slit of the retaining members substantially along a first direction, and wherein a first of the at least two retaining members is disposed behind a second of the retaining members substantially along the first direction.
Claims
1. A support device for supporting an elongated medical instrument comprising: a base; a gripping system for securing the base to a surgical towel; and first and second retaining members disposed spaced-apart from one another on the base and extending upwardly from the base, the first retaining member having a first slit configured to receive a first part of the elongated medical instrument so that the first part is supported by the first retaining member, the second retaining member having a second slit configured to receive a second part of the elongated medical instrument so that the second part is supported by the second retaining member, the first and second slits being aligned with one another along a first direction such that when the elongated medical instrument extends through the first and second slits a portion of the elongated medical instrument located between the first and second slits extends substantially along the first direction, each of the first and second slits including a first segment and a second segment, the first segment being located below the second segment and the first segment being narrower than the second segment.
2. The support device of claim 1, wherein the first and second retaining members are formed integrally with the base.
3. The support device of claim 1, wherein the first and second retaining members or a part of each of the first and second retaining members are detachably fixed to the base.
4. The support device of claim 3, wherein each of the first and second retaining members is made from a first material, and the base is made from a second material, the first material being different from the second material.
5. The support device of claim 1, wherein the first segment has a substantially constant width.
6. The support device of claim 5, wherein the second segment has a substantially V-shaped cross-section.
7. The support device of claim 6, wherein at least one of the first and second slits comprises a third segment and wherein the second segment is located below the third segment.
8. The support device of claim 7, wherein the third segment has a rounded or a substantially ovaloid cross section.
9. The support device of claim 1, wherein the first retaining member has a different shape and/or different dimensions than the second retaining member.
10. The support device of claim 1, wherein the gripping system is formed by a first opening in the base extending substantially along the first direction from a first edge of the base.
11. The support device of claim 10, wherein at least a portion of the opening has a sinusoidal shape.
12. The support device of claim 10, further comprising a second opening extending from a second edge of the base, the second edge being opposite to the first edge and extending along the first direction.
13. The support device of claim 1, further comprising third and fourth retaining members that are disposed spaced-apart from one another on the base and extend upwardly from the base, the third and fourth retaining members disposed aligned with one another substantially along the first direction.
14. The support device of claim 1, wherein the elongated medical instruments are selected from the group consisting of guidewires and catheters.
15. The device of claim 1, wherein each of the first and second retaining members is configured to receive the elongated medical instrument with a diameter ranging from 0.254 mm to 11.3 mm.
16. A support device for supporting an elongated medical instrument comprising: a base; a gripping system for securing the base to a surgical towel; and first and second retaining members disposed spaced-apart from one another on the base and extending upwardly from the base, the first retaining member having a first slit configured to receive a first part of the elongated medical instrument so that the first part is supported by the first retaining member, the second retaining member having a second slit configured to receive a second part of the elongated medical instrument so that the second part is supported by the second retaining member, the first and second slits being aligned with one another along a first direction such that when the elongated medical instrument extends through the first and second slits a portion of the elongated medical instrument located between the first and second slits extends substantially along the first direction, the first retaining member being disposed behind the second retaining member substantially along the first direction, and one or both of the first and second slits including a first segment and a second segment, the first segment being located below the second segment, and the first segment having a substantially constant width and the second segment having a substantially V-shaped cross-section.
17. The support device of claim 16, wherein an angle between a first surface and a second surface forming the second segment is between 2° and 20°.
18. The support device of claim 16, wherein at least one of the first and second slits comprises a third segment having a rounded or substantially ovaloid cross section.
19. A support device for supporting a guidewire and a catheter comprising: a base; a gripping system for securing the base to a surgical towel; and first and second retaining members disposed spaced-apart on the base and extending upwardly from the base, the first retaining member having a first slit configured to receive a part of the guidewire so that the part of the guidewire is supported by the first retaining member, the second retaining member having a second slit configured to receive a part of the catheter so that the part of the catheter is supported by the second retaining member, the first and second slits being aligned with one another along a first direction such that when the guidewire or catheter extends through the first and second slits a portion of the guidewire or catheter located between the first and second slits extends substantially along the first direction, the second slit including a first segment, a second segment, and a third segment, the first segment being located below the second segment, and the second segment being located below the third segment, the first segment being narrower than the second segment, and the third segment having a rounded or substantially ovaloid cross section configured to retain a neck of a hub of the catheter.
20. The support device of claim 19, wherein the first segment and/or the second segment is configured to retain the guidewire.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0039]
[0040] In this particular example, retaining members 400 may be integrally formed with base 200. As will be explained in more detail hereinafter, the retaining members serve to retain a medical instrument, such as e.g. a guidewire or catheter. The support device may be fixed in place on an operating table. The gripping system 300 may be used for that purpose as will be explained hereinafter as well. If the device is fixed on an operating table, the medical instrument retained in it (e.g. guidewire, catheter) may also be fixed in place. Unplanned and undesired movements of the medical instruments may be avoided.
[0041] The base, and in particular the flat portion 210 of the base 200, as shown in
[0042] The groove 230 may have a substantially semi-circular cross-section with different radii and depths depending on the dimensions of the medical instruments. The radius of the groove 230 may substantially match the exterior radius of the medical instrument with the greatest radius (catheter), which is received by the groove, and the depth of the groove may be greater than the exterior diameter of the catheter.
[0043] The gripping system 300 may be formed integrally with the base 200 of the device. In some examples, an opening 330 is provided on an edge of the base 200 that extends inwards into the base. A channel 320 may thus be formed extending substantially along a length of the device.
[0044] The gripping system in this example includes two channels which allow insertion of a surgical towel from opposite directions. The gripping system may also comprise portions 310a, 310b that may have a surface with increased roughness to facilitate gripping by a user, e.g. a nurse or doctor.
[0045] In one example, the support device may be configured to be re-used. After an intervention, the device may be sterilized and prepared for a next intervention. In other examples, device is disposable and configured for single use only.
[0046] Support devices may be made from one or more thermoplastic materials. Suitable thermoplastic materials include Acrylic, ABS, Nylon, PLA, Polybenzimidazole, Polycarbonate, Polyether sulfone, Polyoxymethylene, Polyetherether ketone, Polyetherimide, Polyethylene, Polyphenylene oxide, Polyphenylene sulfide, Polypropylene, Polystyrene, Polyvinyl chloride, Polyvinylidene fluoride, Teflon, any of their derivatives and combinations thereof. Support devices may also be made of thermosetting polymers. Suitable thermosetting polymers include Polyester, Polyurethanes, Polyureaings, Vulcanized rubber, Bakelite, Duroplast, Urea-formaldehyde, Melamine, Diallyl-phthalate, Epoxy resin, Epoxy novolac resins, Benzoxazines, Polyimides, Bismaleimides, Cyanate esters, polycyanurates, Furan resins, Silicone resins, Thiolyte, Vinyl, derivatives and combinations thereof. The support devices may also be made from metals commonly used in the manufacture of medical devices. Suitable metals include stainless steel, and titanium.
[0047] Both fingers 340a and 340b may comprise portions 310a and 310b with higher roughness than the rest of the base 200. This provides a support device 100 that can be gripped easily by an operator, and, moreover, can be held and manipulated with greater accuracy, especially if the portions 310a, 310b are wet during an intervention, or have saline or body fluids on them. Said rough portions 310a and 310b may be part of the fingers 340a and 340b, respectively, and are located near the openings 330a and 330b of the channels. The shape and the surface texture of said portion may be formed such that the device to be held easily by an operator, thus, providing a more efficient manipulating of the device.
[0048] Support device 100 comprises at least two retaining members 410, 420, as shown in
[0049]
[0050] Slit 411 is depicted to be made up of a first segment 414, which has a small opening with a constant width. Particularly, surfaces 412, 413 of slit 411 are formed parallel to each other along the first segment 414, thus, forming an opening with a cross-section of a constant width, suitable for holding medical instruments that may be used during an intervention. Such a segment 414 may be closer to the connection point 417, i.e. at a bottom or lower segment of slit 411. The first segment of the slit may particularly be used for retaining elongated instruments with the smallest cross-section.
[0051] Above the first segment, a second segment 415 of the slit 411 is shown, wherein the surfaces 412, 413 form a substantially V-shaped cross section. The surfaces may form an angle α appropriate for receiving medical instruments of different diameters. Thus, a suitable angle may be selected depending on the types of instruments to be retained. By pushing instruments downwards into the slit, the medical instruments may become retained. A suitable angle may be between 2° and 20°, and specifically between 3° and 15°. The V-shape with varying width of the cross-section enables elongated medical instruments of different cross-sections to be retained. If a medical instrument is relatively small, it will not become retained along the second segment 415 but rather at the thinnest segment 414.
[0052] In this example, another segment, a third segment 416, is formed above the other two segments 415 and 414. The third segment comprises a rounded, ovalloid or somewhat O-shaped cross section formed by a variety of curvatures that can be provided by the surfaces 412, 413. The rounded or ovaloid cross-section may be configured to retain a standard end of a catheter. A variety of different shapes in one slit 411 such as shown in this example provides a device with different retaining effects to the medical instruments, and, makes it possible for a plurality of different medical instruments of different sizes to fit into the slits of the retaining members.
[0053] Slits may be configured to support medical instruments, such as guidewires, catheters, etc. Each medical instrument has different dimensions depending on the expected uses, e.g., type of intervention, therefore, having different segments within the slits with different cross-sections permit for the retention of medical instruments necessary in any type of intervention. For example, the guidewires that are typically used may have different diameters, e.g. 0.038″, 0.035″, 0.018″, 0.014″. The guidewires may have a diameter in the range from 0.254 mm (0.010″) to 0.965 mm (0.038″), while the catheters may have diameters ranging from e.g. 3 French gauge (1 mm) to 34 French gauge (11.33 mm) depending on the expected uses. Alternative shapes and dimensions of the slits will be shown later.
[0054] The dimensions of the slits (thickness and/or angle and/or diameter) may be chosen in relation with the medical instruments to be retained. Other aspects may also contribute to the retaining efficiency of such device. The retaining members may be made of materials that also contribute to the efficiency of the device, as for example, the use of flexible rubber-like materials so as to retain the medical instruments without a need to adapt precisely to the diameters of such instruments.
[0055] In any of the embodiments disclosed herein, slits or portions of the slits may receive a specific treatment to increase roughness. For example, the mold for injection may undergo a local chemical etching treatment to provide the mold with texture locally.
[0056] In any of the embodiments disclosed herein, near a bottom of the slit, one or more small grooves may be provided in the mold used for injection. Such small grooves may result in small notches in the sidewalls of the slit of the support device. These notches can help retain the smallest guidewires. The grooves in the molds may be manufactured using EDM (electrical discharge machining).
[0057] A support device 100, comprising two detachably fixed retaining members 410, 420, is illustrated in
[0058] The flexibility of the retaining members in combination with the different cross-sections of the segments of the slits permits a medical instrument support device to engage elongated medical instruments of different dimensions. In this aspect, the retaining members may comprise slits with one, two or three segments, wherein each segment may have a cross-section of a different shape.
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[0060] Retaining member 440 with slit 441 illustrated in
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[0062] Yet another example of a retaining member 460 is presented in
[0063] The before mentioned figures depict retaining members comprising a variety of slits comprising different segments with cross-sections of different shapes, thus, providing a device that can be implemented with a plurality of medical instruments of different diameters. Although the devices described hereinbefore comprise at least two retaining members having slits with the same shapes, other alternative devices are possible.
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[0066] For different interventions, it may be important to maintain the position of the guidewire(s) and various catheters in place as has already been discussed.
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[0068] As illustrated in
[0069] The catheters used in most interventions have insertion tubes that their diameters ranging from e.g. 3 to 34 French gauge depending on the intended use.
[0070] A support device 100 may also be used to retain a guidewire 500 and a catheter 600, as illustrated in
[0071] In an alternative way, the guidewire 500 and the catheter 600 are retained on device 100, by placing the guidewire 500 in the slit 411 and by fixing the catheter 600 on the slit 421 of the retaining member 420. The catheter is fixed in the slit 421 by fixing the neck 612 of catheter 600 as described in
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[0073] Retaining member 470 further has a base on which a plurality of pins 476 is provided. A thin elongated medical device may be retained in between pins 476. One or more rows of pins 476 may be provided to create a plurality of retaining members next to each other. In this particular example, the retaining member has a brush-like or comb-like appearance with a plurality of rows of pins behind each other.
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[0076] In yet a further non-illustrated example, a gripping may system may be provided in which fingers 340 (as in e.g.
[0077] In any of the examples disclosed herein, the base of the support devices may be substantially rectangular. The length of the support devices in the examples may be between 5 and 20 cm. Specifically, the support device may have a length between 7 and 15 cm. More specifically, the support device may have a length between 8 and 12 cm. The width of the support devices in the examples may be between 5 and 15 cm. Specifically, the support device may have a width between 7 and 12 cm. More specifically, the support device may have a width between 6 and 9 cm. The height of the support devices may be between 1 and 10 cm. Specifically, the height of the support device may be between 3 and 7 cm. In one specific example, the support device has a length between 8 and 12 cm, a width between 6 and 9 cm and a heath between 3 and 7 cm.
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[0079] Within the endovascular procedures that are performed using guides and catheters, increasingly complex procedures have been developed that use more than one guide simultaneously through a vascular access. A vascular access is the entry point of certain medical devices in the form of guides, catheters or others that are introduced into the body through a system named introducer or sheath, which allows to keep these devices in a stable way inside the vessels (arteries or veins).
[0080] There are procedures for the implantation of fenestrated endoprostheses that require the catheterization of a plurality of vessels, e.g. at least three to four vessels in sequence for their implantation but that require stabilization for a period of time, e.g. 30 minutes or more. The actual time will depend on the speed of catheterization and the implantation of the branches.
[0081] Specifically, endoprosthesis systems may treat and/or access the aorta, the superior mesenteric artery, the two renal arteries (right and left) and the celiac trunk. These guides are usually introduced from the same port or access or introducer (at the femoral or axillary level) for which the manipulation must be very precise and great caution must be maintained to avoid sudden movements that cause loss of location.
[0082] To ensure that once they have been catheterized, the correct position of the guides is not lost, it is important that each of the guides and/or catheters can be stabilized and maintained in their position. With the support device 1000, one can ensure the correct fixation of 4 guides or guide/catheter combinations simultaneously. In the illustrated example, the base 200 includes identifying marks or letters of each of the guides to facilitate control over the exact position of each guide.
[0083] In this examples CT indicates celiac trunk, SM indicates superior mesenteric, RR indicates right renal and LR indicates left renal. It will be clear that these letters and indications may be varied for different applications. In alternative examples, e.g. two or three guides or guide/catheter combinations may be used, and the support device 1000 may be adapted for a specific need or intervention.
[0084] With reference to
[0085] Set 400A in this example is intended to fix in place an elongated medical device that accesses the celiac trunk. Guidewire 500 is fixed in both retaining members arranged one behind the other. Guidewire 510 is fixed at two different portions of the guidewire by the set 400B of retaining members. Guidewire 510 in this example may be used to access and/or treat the superior mesenteric artery. Similarly guidewires 520 and 530 used for treating and/or accessing the right renal and left renal artery respectively are fixed in position by sets 400C and 400D of retaining members.
[0086] Similarly as in hereinbefore described examples, the support device 100 may include a gripping system 300 for securing the base 200 to a surgical towel.
[0087] As shown in
[0088]
[0089] As illustrated in
[0090] For reasons of completeness, several aspects of the present disclosure are set out in the following numbered clauses:
[0091] Clause 1. A support device for supporting an elongated medical instrument comprising:
[0092] a base;
[0093] a gripping system for securing the base to a surgical towel; and
[0094] at least two retaining members disposed on the base and extending upwardly from the base, the retaining members having a slit configured to support the elongated medical instrument, such that the elongated medical instrument extends through the slit of the retaining members substantially along a first direction, and wherein
[0095] a first of the at least two retaining members is disposed behind a second of the retaining members substantially along the first direction.
[0096] Clause 2. The support device of clause 1, wherein the retaining members are formed integrally with the base.
[0097] Clause 3. The support device of clause 1, wherein the retaining members or part of the retaining members are detachably fixed to the base.
[0098] Clause 4. The support device of clause 3, wherein the retaining members are configured for a single use.
[0099] Clause 5. The support device of clause 3 or 4, wherein the retaining members are made from a first material, and the base is made from a second material, the first material being different from the second.
[0100] Clause 6. The support device of any of clauses 1-5, comprising two or more sets of retaining members, each set of retaining members comprising a first retaining member disposed behind a second retaining member substantially along the first direction.
[0101] Clause 7. The support device of clause 6, comprising four sets of retaining members.
[0102] Clause 8. The support device of clause 6 or 7, wherein the base comprises one or more identification marks for indicating an elongated medical instrument to be position in one or more set of retaining members.
[0103] Clause 9. The support device of any of clauses 1-8, wherein the slits of one or more of the retaining members comprise a first segment, and a second segment, wherein the first segment is located below the second segment, and wherein the first segment is narrower than the second segment.
[0104] Clause 10. The support device of clause 9, wherein the first segment has a substantially constant width.
[0105] Clause 10. The support device of clause 9, wherein the second segment has a substantially V-shaped cross-section.
[0106] Clause 11. The support device of clause 10, wherein an angle between a first surface and a second surface forming the second segment is between 2° and 20°.
[0107] Clause 12. The support device of any of clauses 8-10, wherein the slit comprises a third segment and wherein the second segment is located below the third segment.
[0108] Clause 13. The support device of clause 11, wherein the third segment has a rounded or substantially ovaloid cross section.
[0109] Clause 14. The support device of clause 9, wherein the second segment has a rounded or substantially ovaloid cross-section.
[0110] Clause 15. The support device of any of clauses 1-14, wherein the first retaining member has a different shape and/or different dimensions than the second retaining member.
[0111] Clause 16. The support device of any of clauses 1-15, wherein the gripping system is formed by a first opening in the base extending substantially along the first direction from a first edge of the base.
[0112] Clause 17. The support device of clause 16, wherein the opening is substantially sinusoidal.
[0113] Clause 18. The support device of clause 16 or 17, further comprising a second opening extending from a second edge of the base, opposite to the first edge and extending along the first direction.
[0114] Clause 19. The support device of any of clauses 1-18, wherein the base has a portion with increased roughness for gripping, and optionally wherein the portion with increased roughness.
[0115] Clause 20. The support device of any of clauses 1-19, wherein the base comprises one or more grooves configured for guidewire threading.
[0116] Clause 21. The support device of clause 20, wherein the one or more grooves for guidewire threading are formed between the gripping system and the retaining members and extend substantially along the first direction.
[0117] Clause 22. The support device of any of clauses 1-21, wherein the elongated medical instruments are guidewires and/or catheters.
[0118] Clause 23. The support device of any of clauses 1-22, wherein the support device is configured to be used and sterilized more than once.
[0119] Clause 24. The support device of clause 23, wherein the support device is made of stainless steel.
[0120] Clause 25. The support device of any of clauses 1-24, wherein the device is configured for a single-use.
[0121] Clause 26. The support device of clause 25, wherein the device is made of a polymer.
[0122] Clause 27. The device of any of clauses 1-26, wherein the retaining members are configured to receive the elongated medical instruments with a diameter ranging from 0,254 mm to 11.3 mm.
[0123] Although only a number of examples have been disclosed herein, other alternatives, modifications, uses and/or equivalents thereof are possible. Thus, the scope of the present disclosure should not be limited by particular examples, but should be determined only by a fair reading of the claims that follow.