Devices for medical guidewire position fixation

Abstract

A device (430,530,630,730,930) for holding a position of a guidewire (405,505,905) on a proximal side of the of a guide catheter (400,500) comprises: an adapter (432,532,632,732,932) comprising a body (438,538,638,738.938), a proximal connector (434,534,634,734) configured to connect to a hemostatic valve (420,520), and a distal connector (436,536,636,736) configured to connect to a hub (406,506) at a proximal end of a guide catheter; an elongated member (440,540,640,740,840,940) extending from the body of the adapter, the elongated member having a fixed end (442,542,642,742,942) in contact with the body and free end (444, 544,644,744,844,944); and means (445,545,845,945) for holding a guidewire at or near a free end of the elongated member.

Description

DEVICES FOR MEDICAL GUIDEWIRE POSITION FIXATIONRELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 581,545, filed on September 8, 2023. The entire teachings of the above application are incorporated herein by reference.BACKGROUND

[0002] In coronary endovascular procedures, coronary vessel access typically involves the use of a guide catheter and a guide wire. In use, the guide catheter is introduced over the guide wire through a skin entrance and into a peripheral vessel. The guide catheter typically extends from the skin entrance all the way to the coronary vessel ostium.SUMMARY

[0003] A device for holding a position of a guidewire on a proximal side of a guide catheter includes an adapter, an elongated member, and means for holding a guidewire. The adapter includes a body, a proximal connector configured to connect to a hemostatic valve, and a distal connector configured to connect to a hub at a proximal end of a guide catheter. The elongated member extends from the body of the adapter and has a fixed end in contact with the body and a free end. The means for holding the guidewire hold the guidewire at or near the free end of the elongated member.

[0004] The elongated member can include various useful and / or advantageous features. For example, the elongated member can include a hinge between the fixed end and the free end such that an orientation of a portion of the elongated member relative to the body of the adapter is adjustable. The elongated member can include an attachment / detachment mechanism between the fixed end and the free end such that a portion of the elongated member is attachable / detachable. The elongated member can include length graduation markings. The elongated member can include a groove for holding the position of the guidewire.

[0005] The elongated member can include a curved portion contiguous with two substantially straight portions, the curved portion being positioned between the two substantially straight portions.

[0006] The means for holding the guidewire can include various useful and / or advantageous features. For example, the means for holding the guidewire can include a magnetic clamp. For example, the magnetic clamp can include at least one ferromagnetic strip, which can be aligned with and / or adjacent a groove for holding the guidewire. The means for holding the guidewire can include a mechanical clamp. The mechanical clamp can include a screw mechanism. The means for holding the guidewire can include adhesive tape.

[0007] The means for holding the guidewire can include a proximal holding mechanism and a distal holding mechanism, the proximal holding mechanism positioned at or near the free end (e.g., proximal end) of the elongated member, the distal holding mechanism positioned between the fixed end (e.g., distal end) of the elongated member and the proximal holding mechanism.

[0008] The proximal connector of the adapter can be a female Luer connector, and the distal connector of the adapter can be a male Luer connector.

[0009] The body of the adapter can define a lumen extending between the proximal and distal connectors for passage of the guidewire.

[0010] A method for holding a position of a guidewire on a proximal side of a guide catheter includes connecting a distal connector of an adapter to a hub at a proximal end of a guide catheter; connecting a proximal connector of the adapter to a hemostatic valve; and holding a guidewire at or near a free end of an elongated member extending from the adapter.

[0011] Holding the guidewire can include using a magnetic clamp. For example, the magnetic clamp can include at least one ferromagnetic strip. Holding the guidewire can include using a mechanical clamp. For example, the mechanical clamp comprises a screw mechanism. Holding the guidewire can include using adhesive tape.

[0012] Holding the guidewire can include holding the guidewire with a proximal holding mechanism and a distal holding mechanism, the proximal holding mechanism positioned at or near the free end of the elongated member, the distal holding mechanism positioned between the fixed end of the elongated member and the proximal holding mechanism. A guidewire held at two locations (e.g. at proximal and distal locations via proximal and distal holding mechanism, respectively) can enable exchange of mono-rail devices while maintaining the wire position.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The foregoing will be apparent from the following more particular description of example embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments.

[0014] FIG. 1 illustrates an example guide catheter for use in endovascular procedures.

[0015] FIG. 2 illustrates positioning of a guide catheter in an aorta and extending a distal end of the guide catheter to a coronary artery ostium.

[0016] FIG. 3 illustrates an example guide catheter coupled to a hemostasis valve and a guidewire extending through the guide catheter.

[0017] FIG. 4 illustrates a guidewire fixation device according to an example embodiment.

[0018] FIG. 5 illustrates another guidewire fixation device according to an example embodiment.

[0019] FIG. 6 illustrates a guide wire fixation device including a mechanism for attaching and detaching a fixation extension according to an example embodiment.

[0020] FIG. 7 illustrates a guidewire fixation device including a hinge according to an example embodiment.

[0021] FIG. 8 illustrates a guidewire fixation extension of a guidewire fixation device according to an example embodiment.

[0022] FIG. 9 illustrates a guidewire fixation device including proximal and distal holding mechanisms according to an example embodiment.

[0023] FIG. 10 illustrates a guidewire holding mechanism for a guidewire fixation device according to an example embodiment.

[0024] FIG. 11 illustrates another guidewire holding mechanism for a guidewire fixation device according to an example embodiment.DETAILED DESCRIPTION

[0025] A description of example embodiments follows.

[0026] In coronary endovascular procedures, coronary vessel access typically involves the use of a guide catheter and a guide wire. FIG. 1 illustrates an example guide catheter 100 for use in a coronary endovascular procedure. The guide catheter 100 includes an elongated shaft 102 that extends between a distal tip 104 and a proximal hub 106 of the guide catheter.The proximal hub 106 can include a connector, e.g., a Luer connector. As illustrated in FIG. 1, the example guide catheter 100 includes a strain relief 108, at or near the proximal end of the shaft 102, and a radiopaque marker 114, at or near the distal tip 104. As further illustrated, the shaft 102 includes or defines a primary curve 110, at or near the distal tip 104, and secondary curve 112, proximal to the primary curve 110. In use, the guide catheter typically extends from a skin entrance all the way to the coronary vessel ostium.

[0027] As illustrated in FIG. 2, a guide catheter 200 is positioned in an aorta 201 with a distal end 204 of a shaft 202 of the guide catheter extended to a coronary artery 203, specifically an ostium of the coronary artery 203. The guide catheter 200 is typically positioned using a guide wire (not shown in FIG. 2 but see FIG. 3).

[0028] FIG. 3 illustrates an example guide catheter 300 that includes a shaft 302 and a distal end 304 and whose proximal end 306 (e.g., hub) is coupled to a hemostasis valve 320. A guidewire 305 extends through the hemostasis valve 320 and the guide catheter 300. The hemostasis valve 320 includes a valve body 322, a distal connector 324, to couple to the hub 306 of the guide catheter 300, and a proximal seal 326, to seal around the guidewire 305 and other devices that are extended through the hemostasis valve 320. In the example illustrated in FIG. 3, the valve 320 is in the shape of a Y-connector, which includes a main passage for receiving the guidewire and / or a catheter, and a branch passage that includes an additional access port 328.

[0029] A hemostasis valve (also referred to as hemostatic valve) is intended to maintain hemostasis during diagnostic / interventional procedures. A conventional hemostasis valve has a rotating seal at one end, which is turned open or closed each time a wire (e.g., guidewire) or microcatheter is introduced or extracted. An example hemostatic valve that includes a push mechanism to seal is described in an article by Namba et al. (Namba K, Song JK, Niimi Y, Heran NS, Berenstein A. A new hemostasis valve for neuroendovascular procedures. Interv Neuroradiol. 2007 Mar;13(l):51-3. doi: 10.1177 / 159101990701300106. Epub 2007 Jun 27. PMID: 20566129; PMCID: PMC3329166). Another example hemostasis valve is the WATCHDOG hemostasis valve manufactured by Boston Scientific. According to the manufacturer, the WATCHDOG hemostasis valve is indicated for maintaining a seal around diagnostic / interventional devices with combined outer diameters of up to 8F (2.67 mm) during diagnostic / interventional procedures.

[0030] Once inserted into body, a guide catheter typically is taped to the skin at the skin entrance. A user may also tape the guidewire to the skin, so as not to ‘lose’ the guidewireduring the endovascular procedure. Fixing the guidewire to the skin using adhesive tape can be problematic, because of the presence of blood and other fluids near the skin entrance, which can interfere with the adhesive properties of the tape. Furthermore, skin is compliant and fixing both the guide catheter and the guidewire to the skin does not prevent relative movement between the guide catheter and the guidewire. Such relative movement, however, is undesirable when the guide wire is used a ‘ruler’ to detect positioning of the guide catheter or other devices during endovascular procedures, such as in recent approaches described by the applicant.

[0031] Examples of systems, devices, and methods providing for position detection of endoluminal instruments are described in International Application No.PCT / US2021 / 072780, titled “Methods and Systems for Body Lumen Medical Device Location,” published as International Publication No. WO 2022 / 126101 A2, the entire teachings of which are incorporated herein by reference.

[0032] FIGs. 4-11 illustrate and the following paragraphs further describe improvements to the systems, devices, and methods provided in Inti. Pub. No. WO 2022 / 126101 A2.

[0033] FIG. 4 illustrates a guidewire fixation device 430 according to an example embodiment. The fixation device 430 enables fixing a position of a guidewire 405 relative to a guide catheter 400 by anchoring the guidewire to the guide catheter outside the lumen of the guide catheter and proximally to a proximal end (e.g., hub) of the guide catheter 400.

[0034] As illustrated, the device 430 is configured for holding the position of a guidewire 405 on the proximal side of a shaft 402 of the guide catheter 400. The device 430 includes an adapter 432 including a body 438, a proximal connector 434 configured to connect to a hemostatic valve 420, and a distal connector 436 configured to connect to a hub 406 of the guide catheter 400. The device 430 further includes an elongated member 440 extending from the body 438 of the adapter 432. The elongated member 440 has a fixed end 442 in contact with the adapter body 438 and a free end 444. The device includes means 445 of holding a guidewire 405 at or near the free end 444 of the elongated member 440.

[0035] The means 445 for holding the guidewire can include one or more of mechanical, magnetic, or adhesive means to hold, e.g., fix, secure, arrest, the guidewire in place. Suitable means for holding the guidewire can include a magnetic clamp, a mechanical clamp, or combinations thereof, as further described herein. The magnetic clamp, for example, can include at least one ferromagnetic strip. The mechanical clamp, for example, can include a screw mechanism. The adhesive means for holding the guidewire, for example, can includeadhesive tape. Alternatively, or in addition, a surface of the elongated member can include or be coated with adhesive material.

[0036] As illustrated in FIG. 4, and similarly illustrated in FIGs. 7 and 9, the elongated member 440 (e.g., the guidewire fixation extension) can include a hinge 446 between the fixed end 442 and the free end 444, such that an orientation of a portion of the elongated member 440 relative to the body 438 of the adapter 432 is adjustable. Here, the elongated member 440 is in an L shaped configuration comprising a longer, straight portion connected via the hinge 446 to a shorter, straight portion. The ability to adjust the orientation of a portion of the elongated member 440 via the hinge can facilitate placement of the guidewire 405 or other devices during the medical procedure. Alternatively, or in addition, the elongated member can include an attachment / detachment mechanism between the fixed end and the free end such that a portion of the elongated member is attachable / detachable, as illustrated in FIG. 6. A main advantage of the hinge design of FIG. 4, and similarly the detachable design of FIG. 6, is that the clinician can move the elongated member 440 out of the way when not in use and bring it back when needed.

[0037] FIG. 5 illustrates a guidewire fixation device 530 according to an example embodiment. The fixation device 530 enables holding, e.g., fixing, a position of a guidewire 505 relative to a guide catheter 500 by anchoring the guidewire to the guide catheter outside the lumen of the guide catheter and proximally to the proximal end (e.g., hub 506) of the guide catheter 500. The device 530 includes an adapter 532 including a body 538, a proximal connector 534, and a distal connector 536. The proximal connector 534 (e.g., a female Luer connector) is configured to connect to a connector 524 (e.g. a male Luer connector) of a hemostatic valve 520. The distal connector 536 (e.g., a male Luer connector) is configured to connect to a connector (e.g., a female Luer connector) of the hub 506 of the guide catheter 500.

[0038] The device 530 includes an elongated member 540 extending from the body 538 of the adapter 532. A fixed end 542 of the elongated member 540 is in contact with the adapter body 538; the other end 544 (e.g., free end) is not in contact with the adapter body. The elongated member 540 can be generally L shaped and include two or more relatively straight portions coupled by one or more curved portions. The elongated member 540 is adapted to contact a guidewire 505 to enable holding the guidewire in place. The device 530 includes a guidewire holding mechanism 545 (e.g., holding means) configured for holding the guidewire 505 at or near the free end 544 of the elongated member 540. As illustrated,the holding mechanism 545 includes a clamp 548 to secure the guidewire 505 against a surface 547 of the member 540. The clamp 548 can be a magnetic clamp and include one or more magnetic strips (e.g., ferromagnetic strips), as further illustrated and described herein (see, e.g., FIG. 8). A groove may be formed in the surface 547 to receive the guidewire and hold the position of the guidewire, as further illustrated and described herein (see., e.g., FIGs. 8, 10, 11). As illustrated, the guidewire 505 extends through the holding mechanism 545 and into a seal 526 of the hemostatic valve 520.

[0039] As illustrated in FIG. 5, the body 538 of the adapter 532 defines a lumen 535 that extends between the proximal and distal connectors 534, 536. The lumen 535 is configured for passage of the guidewire 505 and other medical devices, e.g., catheters. The lumen 535 also allows for passage of fluids, e.g., saline.

[0040] FIG. 6 illustrates a guidewire fixation device 630 including a mechanism 650 for detaching and attaching a fixation extension 640 (e.g., an elongated member). The fixation device 630 enables holding a position of a guidewire (not shown in FIG. 6) relative to a guide catheter by anchoring the guidewire to the guide catheter. The device 630 includes an adapter 632 including a body 638, a proximal connector 634, and a distal connector 636, similar to the device 530 of FIG. 5. The fixation extension 640 extends from the body 638 of the adapter 632 and includes a fixed end 642 that is in contact with the adapter body 638 and a free end 644. The detaching / attaching mechanism 650 includes screw 652 that engages a threaded portion of the fixed end 642 to fasten the detachable portion of the extension 640 to the threaded portion that is connected to adapter 632. A guidewire fixation surface 647 is provided at or near the free end 644 of the fixation extension 640.

[0041] The detachable wire fixation extension 640 includes a relatively straight portion having length LI, a relatively curved portion having length L2, and another relatively straight portion having length L3. As illustrated, the portions are contiguous and may be formed monolithically. As further illustrated, the relative lengths of the portions are such that L3 > LI > L2. In other words, the two straight portions are connected by a relatively shorter curved portion. Where the curved portion is S shaped, as shown, the straight portions, i.e. having lengths LI and L3, are parallel to each other but offset by an amount determined by the curved portion. The portion that includes the free end 644, i.e., the portion having length LI, can be aligned with a longitudinal axis of the adapter body 632.

[0042] FIG. 7 illustrates a guidewire fixation device 730 including a guidewire fixation extension 740 (e.g., an elongated member) featuring a hinged design. A hinge 746 ispositioned between a fixed end 742 of the extension 740 and a free end 744 of the extension 740. The device 730 includes an adapter 732 including an adapter body 738, a proximal connector 734 to couple to a hemostatic valve, and a distal connector 736, to couple to a guide catheter. The hinge 746 enables adjustment of the orientation of a portion of the elongated member 740 relative to the body 738 of the adapter 732. Similar to the fixation extension 640 of FIG. 6, the fixation extension 740 includes, in order starting from the free end 744, a relatively straight portion having length LI, a relatively curved portion having length L2, and another relatively straight portion having length L3.

[0043] FIG. 8 illustrates a guidewire fixation extension 840 (e.g., an elongated member) of a guidewire fixation device according to an example embodiment. Means 845 for holding a guidewire (not shown) are provided at free end 844 of the extension 840. As illustrated, the means for holding can include a magnetic clamp that includes at least one ferromagnetic strip 860. Here, two ferromagnetic strips 860 are provided, which are positioned on either side of a groove 849 for receiving the guidewire. To clamp the guidewire, another piece is used, such as clamp 545 (FIG. 5), which magnetically attaches to the strips 860. The groove 849 is formed in wire fixation surface 847 of the extension 840. The ferromagnetic strips 860 can be attached to or integrated in the surface 847.

[0044] As illustrated in FIG. 9, a guidewire fixation device 930 for holding a guidewire 905 includes an adapter 932 and an elongated element 940. A fixed end 942 of the elongated element 940 extends from the body 938 of the adapter 932. Similarly to the embodiment of FIG. 7, the elongated element 940 includes a hinge 946, which is positioned between the fixed end 942 and the free end 944 and near the fixed end 942. The device includes means for holding the guidewire that include two holding mechanisms, a proximal (e.g., first) holding mechanism 945a and a distal (e.g., second) holding mechanism 945b. The proximal holding mechanism 945a is positioned at or near a free end 944, e.g. a proximal end, of the elongated member 940. The distal holding mechanism 945b is positioned between the fixed end 942, e.g. distal end, of the elongated member 940 and the proximal holding mechanism 945a. As illustrated, the first and second holding mechanisms 945a, 945b can be spaced apart by a distance D.

[0045] Advantageously, providing two holding mechanisms (e.g., a proximal and a distal holding mechanism) allows for improved delivery of a rapid exchange device (e.g., a device having a short monorail) over the guidewire, as one of the two holding mechanisms can engage a portion of the guidewire while the other of the two holding mechanisms can bereleased from another portion of the guidewire to allow for advancement of the rapid exchange device over the other portion of the guidewire. The first and second holding mechanisms (e.g., 945a, 945b in FIG. 9) can be spaced apart by a distance (e.g., distance D in FIG. 9) that is equal to or greater than a length of a monorail of a rapid exchange device. In some embodiments, the first and second holding mechanisms are spaced apart by about 20 centimeters.

[0046] Similar to the embodiments of FIGS. 6 and 7, respectively, the elongated element 940 includes, in order starting from the free end 944, a substantially straight portion having length LI, a substantially curved portion having length L2, and another substantially straight portion having length L3. Unlike in the embodiments of FIGS. 6 and 7, however, the portion having length LI is longer than the other portions, i.e., LI > L3 > L2. The increased length LI allows for the positioning, and spacing, of the two holding mechanisms 945a and 945b.

[0047] The devices described herein, such as device 430, 530, 630, 730, 930 (FIGS. 4, 5, 6, 7, 9), can be used to hold (e.g., fix, secure, etc.) a position of a guidewire during an endoluminal procedure.

[0048] A method for holding a position of a guidewire (305, 405, 505) on a proximal side of the of a guide catheter (300, 400, 500) includes connecting a distal connector of an adapter (432, 532, 632, 732, 932) to a hub of a guide catheter, connecting a proximal connector of the adapter to a hemostatic valve (320, 420, 520), and holding a guidewire at or near a free end of an elongated member extending from the adapter.

[0049] FIG. 10 illustrates a screw-based guidewire holding mechanism 1045 for holding a guidewire (not shown) in a groove 1049 of an elongated member 1040. The mechanism includes a screw 1070 having a thread to engage a threaded portion of the elongated member 1040. The head of the screw 1070 clamps the guidewire in position in the groove 1049.

[0050] FIG. 11 illustrates a guidewire fixation extension 1140 (e.g., elongated member) including a wire fixation surface 1147 with distance markings 1182 (e.g., length graduation markings) and means for holding the guidewire (no shown) in groove 1149 using adhesive tape 1180. Since some guidewires also have distance markings at their proximal ends, providing distance markings 1182 on the fixation extension 1140 can help the guidewire to be positioned back to the same place if moved during the medical procedure.

[0051] The teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety.

[0052] While example embodiments have been particularly shown and described, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the embodiments encompassed by the appended claims.

Claims

CLAIMSWhat is claimed is:

1. A device for holding a position of a guidewire on a proximal side of a guide catheter, the device comprising: an adapter comprising a body, a proximal connector configured to connect to a hemostatic valve, and a distal connector configured to connect to a hub at a proximal end of a guide catheter; an elongated member extending from the body of the adapter, the elongated member having a fixed end in contact with the body and a free end; and means for holding a guidewire at or near the free end of the elongated member.

2. The device of claim 1, wherein the elongated member further comprises a hinge between the fixed end and the free end such that an orientation of a portion of the elongated member relative to the body of the adapter is adjustable.

3. The device of claim 1, wherein the elongated member further comprises an attachm ent / detachment mechanism between the fixed end and the free end such that a portion of the elongated member is attachable / detachable.

4. The device of any one of claims 1-3, wherein the elongated member includes length graduation markings.

5. The device of any one of claims 1-4, wherein the elongated member includes a groove for holding the position of the guidewire.

6. The device of any one of claims 1-5, wherein the means for holding the guidewire is a magnetic clamp.

7. The device of claim 6, wherein the magnetic clamp comprises at least one ferromagnetic strip.

8. The device of any one of claims 1-5, wherein the means for holding the guidewire is a mechanical clamp.

9. The device of claim 8, wherein the mechanical clamp comprises a screw mechanism.

10. The device of any one of claims 1-5, wherein the means for holding the guidewire is adhesive tape.

11. The device any one of claims 1-5, wherein the means for holding the guidewire comprises a proximal holding mechanism and a distal holding mechanism, the proximal holding mechanism positioned at or near the free end of the elongated member, the distal holding mechanism positioned between the fixed end of the elongated member and the proximal holding mechanism.

12. The device any one of claims 1-11, wherein the proximal connector is a female Luer connector and the distal connector is a male Luer connector.

13. The device any one of claims 1-12, wherein the body of the adapter defines a lumen extending between the proximal and distal connectors for passage of the guidewire.

14. A method for holding a position of a guidewire on a proximal side of the of a guide catheter, the comprising: connecting a distal connector of an adapter to a hub at a proximal end of a guide catheter; connecting a proximal connector of the adapter to a hemostatic valve; and holding a guidewire at or near a free end of an elongated member extending from the adapter.

15. The method of claim 14, wherein holding the guidewire includes using a magnetic clamp.

16. The method of claim 15, wherein the magnetic clamp comprises at least one ferromagnetic strip.

17. The method of claim 14, wherein holding the guidewire includes using a mechanical clamp.

18. The method of claim 17, wherein the mechanical clamp comprises a screw mechanism.

19. The method of claim 14, wherein holding the guidewire includes using adhesive tape.

20. The method of any one of claims 14-19, wherein holding the guidewire includes holding the guidewire with a proximal holding mechanism and a distal holding mechanism, the proximal holding mechanism positioned at or near the free end of the elongated member, the distal holding mechanism positioned between the fixed end of the elongated member and the proximal holding mechanism.

21. The device of any one of claims 1-13 or method of any one of claims 14-20, wherein the elongated member includes a curved portion contiguous with two substantially straight portions, the curved portion positioned between the two substantially straight portions.

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