WO2010006037A1 - Guidewire and catheter management device - Google Patents

Abstract

Provided are devices, systems, and methods for catheter and guidewire management in a surgical setting. In one implementation, the device may include a housing having a curved bottom surface for accommodating the shape of a patient's leg. Into the housing is mounted a retaining member, which can retain one or more guidewires, catheters, or the like. In another embodiment, the housing may include a number of vertical supports between which is mounted at least one retaining member housing. The retaining member housing may in turn house a retaining member, suitable for receiving and retaining one or more elongated devices such as catheters or guidewires. The retaining member may have a suitable size, shape, and level of flexibility to allow a catheter or guidewire to be placed therein and held with a desired level of force until such a time as a user desires to remove the catheter or guidewire. Using the device, catheter/guidewire combinations or other such paired devices, or indeed any devices, may be effectively managed in a surgical field.

Description

GUIDEWIRE AND CATHETER MANAGEMENT DEVICE

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Patent Application Serial No. 12/217,852, filed July 8, 2008, and U.S. Patent Application Serial No. 12/498,985, filed July 7, 2009, the entireties of which are incorporated by reference herein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not Applicable

BACKGROUND OF THE INVENTION

[0003] Field of the Invention - This invention is in the field of equipment used for intravascular medical procedures, specifically flexible elongated members such as guidewires and catheters that are introduced into a patient's blood vessel. [0004] Background Art - Invasive vascular procedures like balloon angioplasty and stent implantation require insertion of a guide catheter into the vasculature, usually in the femoral (leg) artery and directing the catheter to the vasculature in need of treatment, such as the heart. Through this catheter, a thin (for example 0.014 inch) wire called a guidewire, is introduced and threaded down the artery to be treated. An additional catheter or other flexible elongated member can be introduced over, or alongside, the guidewire.

[0005] The catheter prior art is replete is variations. For example, rapid exchange catheters are also used, where a guidewire enters a lumen in the distal tip of the catheter and then exits anywhere from about 1 cm to 40 cm from the distal tip, running alongside the catheter but outside of the same. In "over-the-wire" catheters, the guidewire runs inside the catheter throughout its length. [0006] At times, the operator must treat or protect more than one vessel using the same guide catheter. In this circumstance, the operator passes two or more pairs of flexible elongated members through the same Y adaptor. The multiple flexible elongated members travel down the same guide catheter and then enter the vessel requiring treatment, with each guidewire and its associated catheter usually entering a different vessel or branch vessel in need of treatment.

[0007] The multiple guidewires and their respective catheters enter the guide catheter through the sealable entry site of the Y adaptor. Since the guidewire/catheter pairs have the same point of entry at the Y adaptor, the operator must take steps to keep the wire/catheter pairs separate from each other, and to keep each guidewire identified with the correct catheter. It is important to keep the wire/catheter pairs separate for several reasons. If the wire/catheter pairs become twisted, they will interact with one another; for instance, when the operator moves one wire or catheter, another wire or catheter may also move. Further, different devices, such as stents, are typically passed over the guidewires on the catheters; therefore, if the wire/catheter pairs become twisted with each other, accurate advancement of the associated devices is hindered. Also, since different devices are passed over the different wires on the catheters, the operator must take steps to identify each wire so as not to confuse which wire is going down which vessel or branch vessel.

[0008] Currently, the prevalent method of separating wire/catheter pairs is to use layers of sterile towels. However, towels are bulky and difficult to control. Towels securing guidewires also lie on the operative field and if the Y adaptor is moved, the towels tend to stay in place, so that the guidewires may be inadvertently pulled out of the vessel. [0009] A procedure can often involve the use of two wire/catheter pairs, or sometimes even three or four. Typically, the physician takes up a guidewire and its associated catheter and works with them, then puts them down and takes up a different wire/catheter pair and works with it. In the process, the free ends of the wire/catheter pairs outside the Y adaptor can become wrapped around each other. During a complicated procedure, the free ends of the wire/catheter pairs can become greatly interwoven. The cause of this problem is that the various wire/catheter pairs exit through the same port in the Y adaptor, and that their free ends are more or less free to lie along somewhat parallel paths on the surgical field, hindering adequate identification, control, or organization. [0010] It is an object of the present invention to provide an apparatus which will allow the operator to efficiently identify, organize, and manage two or more pairs of guidewires and their associated catheters. It is also an object of the present invention to provide a device for catheter and guidewire management that can be conveniently secured in place to an operating field.

BRIEF SUMMARY OF THE INVENTION

[0011] One system provides a small, firm but pliable pad that can lie on the surgical field, separated from the Y adaptor. The pad can be attached to drapes or some other item in the surgical field, such as by clamping, so as to maintain its desired position relative to the Y adaptor. The pad typically has between two and four pairs of grooves or clamps on it, adapted to hold in place two to four associated pairs of flexible elongated members, with each associated pair of flexible elongated members typically consisting of a guidewire and a catheter. The flexible elongated members in each pair are said herein to be "associated" with each other because the guidewire and the catheter are used together. The grooves or clamps can be arranged in a curved layout, so as to "fan out" the wire/catheter pairs and assist in keeping the free ends of each wire/catheter pair separated from the free ends of other pairs. The grooves or clamps are designed to allow easy insertion and removal of the flexible elongated members. Some of the grooves or clamps can be designed to securely hold a wire or catheter against axial movement, while others can be designed to simply hold a wire or catheter in place relative to the other pairs, without restricting the axial movement of the wire or catheter being held. [0012] The pad can have an adhesive surface on its lower side, to allow it to be adhered to a drape or other item to keep it in place on the surgical field, with a selected separation from, and orientation relative to, the Y adaptor. Other ways to secure the pad or other devices are described below. The adhesive surface can be selectively exposed by removing a peel-off cover. Alternatively, tabs can be provided on the pad, allowing it to be clamped in the desired location and orientation by surgical clamps, or other clamping devices. [0013] The pad can also have labels for identifying each wire and each catheter, or each wire/catheter pair. These can be stick-on type labels, or surfaces adapted for writing upon, or they can be pre-molded labeling areas on the pad, with punch-out circles identifying the selected location of each wire/catheter pair.

[0014] Another device for guidewire and catheter management includes a rigid housing having a curved bottom surface for accommodating the shape of a patient's leg. The rigid housing may also have a flat bottom, or may have a bottom in which one portion is flat and another is curved. Flat bottom housings may be appropriate where the device is intended to be placed on an operating or other table instead of on a patient's leg or other curved surface.

[0015] In one implementation, the housing includes a number of vertical supports between which are mounted at least one retaining member housing. The retaining member housing may in turn house a retaining member, suitable for receiving and retaining an elongated device such as a catheter or guidewire. The retaining member may have a suitable size, shape, and level of flexibility to allow a catheter or guidewire to be placed therein and held with a desired level of force until a user desires to remove the catheter or guidewire. The retaining member may include one or more slots or grooves for retaining one or more catheters and/or guidewires. Using the device, catheter/guidewire combinations or other such paired devices, or indeed any devices, may be effectively managed in a surgical field.

[0016] The device may have one or more attachment mechanisms to allow the same to be secured in an operating field onto, e.g., a fabric such as a towel draping a patient. The attachment mechanisms may be of a number of types of construction, and may include towel clamps with springs or clips, flexible fork assemblies, flexible tabs, hinged tabs, wire capture systems, gripping ring with flexible fingers, wire-and-plug capture systems, and opposing finger towel capture systems.

[0017] The novel features of this invention, as well as the invention itself, will be best understood from the attached drawings, taken along with the following description, in which similar reference characters refer to similar parts, and in which: BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0018] Figure 1 is a plan view of a first embodiment of a guidewire/catheter management device according to the present invention, utilizing grooves to hold the flexible elongated members;

[0019] Figure 2 is a partial section view, showing one type of groove that may be used in the embodiment shown in Figure 1;

[0020] Figure 3 is a plan view of a second embodiment of a guidewire/catheter management device according to the present invention, utilizing spring clamps to hold the flexible elongated members;

[0021] Figure 4 is a partial edge view of the embodiment shown in Figure 3;

[0022] Figures 5(A) - 5(G) illustrate various views of a third embodiment of a guidewire/catheter management device according to the present invention;

[0023] Figures 6(A) - 6(E) illustrate multiple views of a fourth embodiment of a guidewire/catheter management device, according to the present invention;

[0024] Figures 7(A) - 7(F) illustrate multiple views of a fifth embodiment of a guidewire/catheter management device, according to the present invention;

[0025] Figures 8(A) - 8(G) illustrate multiple views of a sixth embodiment of a guidewire/catheter management device according to the present invention, employing a ribbed retaining member;

[0026] Figures 9(A) and 9(B) are perspective and side views, respectively, of a first embodiment of an attachment mechanism for attaching a device to a towel, e.g., as may be draping a patient during surgery, here implemented as a towel clamp with spring;

[0027] Figures 10(A) and 10(B) are perspective and side views, respectively, of a second embodiment of an attachment mechanism for attaching a device to a towel, e.g., here implemented as a towel clamp with clip;

[0028] Figures H(A) and H(B) are perspective and side views, respectively, of a third embodiment of an attachment mechanism for attaching a device to a towel, e.g., here implemented as a flexible fork assembly, which may be employed with or without a spring; [0029] Figures 12(A) and 12(B) are perspective and side views, respectively, of a fourth embodiment of an attachment mechanism for attaching a device to a towel, e.g., here implemented as a flexible tab assembly;

[0030] Figures 13(A) and 13(B) are perspective and side views, respectively, of a fifth embodiment of an attachment mechanism for attaching a device to a towel, e.g., here implemented as a hinged cover with a snap-button assembly;

[0031] Figures 14(A) and 14(B) are perspective and side views, respectively, of a sixth embodiment of an attachment mechanism for attaching a device to a towel, e.g., here implemented as a sliding wire capture lock;

[0032] Figures 15(A) and 15(B) are perspective and side views, respectively, of a seventh embodiment of an attachment mechanism for attaching a device to a towel, e.g., here implemented as a gripping ring with flexible fingers; and

[0033] Figures 16(A) and 16(B) are perspective and side views, respectively, of a eighth embodiment of an attachment mechanism for attaching a device to a towel, e.g., here implemented as a capture wire with engagement button assembly.

DETAILED DESCRIPTION OF THE INVENTION

[0034] As shown in Figure 1, a first embodiment of the device 10 of the present invention includes a pad 12 with a plurality of pairs of grooves 14, 15 in its upper surface. Alternatively, the grooves 14, 15 could be formed in a body of flexible material that is mounted on the pad 12. The pad 12 is constructed of a firm but flexible material. Two or more flat tabs 13 can be formed on the pad 12, to provide surfaces to which surgical clamps can be attached, to hold the pad 12 on a surgical drape, in a selected position and orientation relative to a Y adaptor. Each pair of grooves 14, 15 has an associated label 16, identifying the guidewire GW and the catheter CA that are secured in the respective groove pair. A first pair of flexible elongated members FEMl can be secured in a first pair of grooves 14, 15, near one end of the pad 12, with a guidewire GW in a first groove 14 and a catheter CA in a second groove 15. Similarly, a second pair of flexible elongated members FEM2 can be secured in a second pair of grooves 14, 15 near the opposite end of the pad 12. Also, if desired, a third pair of flexible elongated members FEM3 can be secured in a third pair of grooves 14, 15 near the center of the pad 12. Further, four or more pairs of grooves 14, 15 can be provided on the pad 12, without departing from the present invention.

[0035] The guidewire grooves 14 are preferably slits in the upper surface of the pad 12. The slit can be pushed open and the guidewire GW inserted laterally into the slit, which will then close back around the guidewire GW and hold it in place. That is, this type of groove 14 is designed to grip the guidewire GW and prevent it from moving either in the transverse direction TD or in the axial direction AD, with respect to the groove 14, or relative to the pad 12. This is often preferable with guidewires, since they must be prevented from moving relative to the blood vessel in which they have been placed. [0036] The catheters can also be captured in this slit type of groove, if desired. However, many catheters, being larger in diameter than the guidewires, and carrying larger diameter devices, can be placed in the type of groove 15 illustrated in Figure 2. That is, rather than a simple slit in the pad 12, this type of groove 15 comprises an open groove, with a tubular cross section 17 below the surface of the pad 12. The surface opening of the groove 15 can be forced open to allow lateral insertion of the catheter CA. Then, the surface opening of the groove 15 will close back around the catheter CA sufficiently to hold it in place against transverse motion relative to the groove 15, or relative to the pad 12. The diameter of the tubular cross section 17 can be selected to closely grip the diameter of the catheter CA, or it can be larger. If the diameter of the tubular cross section 17 fits closely to the catheter CA, it can secure the catheter CA against axial movement relative to the groove 15, and relative to the pad 12. Conversely, if the diameter of the tubular cross section 17 is larger than the diameter of the catheter CA, it can allow the catheter CA to move axially within the groove 15. This can be desirable with some balloon catheters.

[0037] The labels 16 can be simply surfaces adapted to be written upon, or stick-on labels with pre-printed identifiers. Or, the labels 16 can be integrally molded into the pad 12, with several possible identifiers listed thereon. These identifiers could include typical guidewire locations, such as LAD, RCA, or CIRC, or even M for Main Artery or B for Branch Artery, etc. Next to each item listed on the label could be a punch-out depression allowing the operator to simply punch a hole next to the item which correctly identifies the location of the associated pair of guidewire and catheter, as the pair is placed in the grooves 14, 15. Alternatively, the operator could simply place a check mark on the label next to the appropriate identifier.

[0038] Figure 3 shows a second embodiment 10' of the present invention. Rather than grooves in the pad 12, this embodiment utilizes spring clamps 18, 19 to hold the pairs of flexible elongated members in place. That is, the guidewire GW of a first pair FEMl can be placed in a spring clamp 18 near one end of the pad 12, and the associated catheter CA can be placed in the associated spring clamp 19. Here as before, labels 16 are provided to identify the pair of flexible elongated members that are secured in each pair of clamps 18, 19. Figure 4 is an edge view of the pad 12 shown in Figure 3, in a "flattened" view to better illustrate the functioning of the spring clamps 18, 19. A first type of spring clamp 18 could be used to clamp either a guidewire GW or a catheter CA to the pad 12, by simply pressing it against the pad 12. The operator presses down on the wing 21 of the spring clamp 18 to open it, inserts the guidewire GW or catheter CA laterally under the edge of the clamp 18, and releases the wing 21, allowing the clamp 18 to clamp the flexible elongated member tightly against the pad 12. This prevents either transverse or axial movement of the guidewire or catheter relative to the pad 12.

[0039] However, another type of spring clamp 19 could also be used where axial movement of the flexible elongated member is desired, such as with some balloon catheters. In this type of clamp, a partial tubular cross-section is provided, within which the flexible elongated member can be placed. As the wing 22 of the clamp 19 is released by the operator, the end of the clamp closes tightly against the pad 12, capturing the catheter CA within the tubular cross-section. If the diameter of the tubular cross-section is larger than the diameter of the catheter CA, the catheter CA is held in place against transverse movement relative to the pad 12, but it is allowed to move axially relative to the pad 12.

[0040] The pad shown in Figure 3 can also have the clamping tabs 13 shown on the first embodiment. Alternatively, or in addition, either embodiment can have an adhesive strip 23 on the bottom of the pad 12, as shown in Figure 4. The adhesive strip 23 can be covered by a peel-off cover until used. Either method of holding the pad 12 in place is capable of positioning the pad 12 at a desired distance from the Y adaptor, and holding the pad 12 in a desired orientation relative to the Y adaptor. [0041] With either embodiment, it can be seen that the pairs of grooves 14, 15 or the pairs of clamps 18, 19 are arranged in a "fanned" pattern or arrangement on the pad 12, so as to angularly separate or disperse the free ends of the pairs of flexible elongated members FEMl, FEM2, FEM3 from each other. This angular dispersement is illustrated by the angles A, B between the free ends of adjacent pairs of flexible elongated members in Figure 1.

[0042] Figures 5(A) - 5(G) illustrate a third embodiment 30 of the present invention; a guidewire 80a and catheter 80b are illustrated as being retained by the device (these elements are in Figures 6-8). In this embodiment, a number of gripping components 24a, 24b, 24c, etc., are mounted on a top surface 34 of a housing 40. The housing 40 may have a curved base 26 so that if the housing 40 is placed on a patient, the curved base 26 will fit comfortably and securely on the patient's leg or the like. An attachment mechanism 50 is also illustrated, the attachment mechanism 50 including two opposing fingers 28 and 32, between which a towel draping the patient may be inserted to hold the device 30 in place. A series of teeth are illustrated at the ends of fingers 28 and 32 to further assist the gripping of a towel. Other types of attachment mechanisms are described below with respect to Figures 9-16.

[0043] Referring in addition to Figure 5(C), the gripping components 24a, 24b, etc., include various features to allow their mounting in the top surface 34 as well as to allow a catheter or guidewire to be inserted and gripped between the components, i.e., frictionally held within the gap between component 24a and component 24b.

[0044] To hold the gripping component 24i on the housing, a snap-fit device 42i (Figure 5(E)) may be employed to frictionally and mechanically hold the component 24i to the housing 40. A strip 41 with plugs 43 i may be employed to give further support to components 24i, as well as to assist in the centering, placement, and retention of components 24i in the housing 40. A variety of other devices and techniques will be understood to be employable to retain component 24i on the housing, given this teaching. In addition, to assist the placement of a catheter or guidewire within the gap, the tops of the gripping components 24a, 24b, etc., may include surfaces 36 and 38 which are configured to form a "V" when placed next to each other, as shown in Figures 5(B), 5(C), 5(E), and 5(F). The "V" shape makes placement of a catheter or guidewire highly convenient for a nurse or physician.

[0045] The cross-section of the components 24i may be seen in Figure 5(G). The benefits of a substantially or generally triangular cross-section are described below.

[0046] In one manufacturing method, a molded silicone (or other suitable material) rod of triangular end profile may be cut or sliced to form the slots or grooves.

[0047] Another manufacturing method takes advantage of vertical supports 54a and 54b.

That is, as illustrated in Figure 5(C), vertical supports 54a and 54b may be employed to hold the group of components 24i to the housing. The vertical supports 54a and 54b may be particularly important when the components 24i are formed in an open mold process, which results in a molded part that resembles Figure 5(E), that is, such that the slit or groove is in a substantially open configuration. The part takes the proper shape, such that the slots are in a closed configuration, when the part is compressed and inserted into the housing 40. This method of manufacturing has a high degree of accuracy and repeatability.

[0048] In more detail, the part is molded as shown in Figure 5(E), and the flexible properties of elastomers allow for a small hinge point at generally the base of the slit.

The slit may then be designed "open", such that the injection mold may carry a core of sufficient strength to withstand cavity injection pressures of 15,000 - 20,000 psi. In some cases, it may be difficult to mold the slit such that the same is "closed", as the minimum thickness (0.020, or 0.5 mm) blade forming the core may generally not take the pressure and may generally be too thick.

[0049] In some cases, the suction or "grab" on the wires may be excessive when an elastomer, e.g., TPE, is used, rather than silicone. A solution, described below in relation to Figures 8(A) - 8(G), is to use a ribbed slot, which has less surface area. In addition, ribs allow for a strong and easily-fabricated core for the injection mold. Whether ribs are used or not, an angle between the faces may be 0, 1, 2, 3, 4, or more degrees, as well as values in between.

[0050] For elastomeric materials, it is noted that the material properties of an elastomer are such that the same may "cold- flow", or form itself around the surface of an intruding member, such as a guidewire. It is minimal on a larger diameter wire as there is less surface area of the wire relative to the material property, or Shore. Cold-flow is more pronounced over a smaller surface area for a small diameter guidewire. There is a balance of stiction between large and small wire diameters. There is less surface area in the upper half of the slit where a larger wire would nominally be used (there is a natural "tactile" sense as to maximum depth) due to a smaller triangular end profile. There is increasing surface area (applied generally to the wire) in the lower half of the slit where the smaller wire is used, due to the larger surface area provided by the triangular end profile. The result is that the design tends to balance out the stiction, or grab, of various wire diameters.

[0051] A fourth embodiment 50 is illustrated in Figures 6(A)-6(E), in which a housing 51 includes a plurality of vertical supports 78a-78d, which extends upward from a top surface 48. Between the at least two vertical supports 54a, 54b, etc., are disposed one or more retaining members 82a-82c. It will be understood that the number of vertical supports and the number of retaining members can vary widely. By this modular construction, different retaining members may be switched out and replaced according to the requirements of the user. In addition, the pliable nature of the retaining members is reinforced by the more rigid retaining member housing. Each retaining member may include one, two, or more slots or grooves in which flexible elongated members such as catheters or guidewires may be placed and retained (two slots are shown). [0052] The housing 51 may have a curved base 52 so that if the housing 51 is placed on a patient, the curved base 52 will conform to and fit comfortably and securely on the patient's leg or the like. The curved base 52 may have a bottom surface that includes protuberances, which help to grip the towel and further prevent movement of the device 50. The protuberances are generally formed on a bottom surface of the housing or body. In cases where the housing 51 is placed on the table itself, the components forming the housing, and/or an optional attachment mechanism, are provided at least partially with a flat base 111 to accommodate the flat table. Of course, in some implementations, the entire device may be designed to be flexible so that the user may bend the device around the patient's leg or other limb, to fit a variety of limbs. It is also noted that the top surface 48 may be curved. The curved base may work with the various attachment mechanisms described to fully secure the catheter and guidewire management device to a patient. [0053] Referring in particular to Figures 6(C) and 6(E), the retaining members 82a-82c include various features to allow the same to be mounted in the supports 78a-78d as well as in the top surface 48 of the housing 51. Referring to Figures 6(C) - 6(E), to hold the retaining members within the housing, fitted end components 84a and 84b may be employed. The fitted end components cooperate with the vertical supports to frictionally hold the retaining members to the housing. A variety of other devices and techniques will also be understood to be employable, given this teaching.

[0054] The retaining members also have features to accommodate a catheter or guidewire such that the same may be inserted and gripped within the retaining member, i.e., frictionally held within a gap defined in or by the shape of the retaining member. [0055] Slots may differ in their taper (not shown). One may have a pronounced taper, and one may have a very small taper. Larger tapers may be appropriate for many catheters (with a typical size being on the order of 0.020 to 0.040 inches), while smaller tapers may be appropriate for many guidewires (with a typical size being on the order of 0.014 inches). This is of course highly arbitrary, and any combination of retaining members may be employed, including systems with only one type of retaining member. [0056] To assist the manufacturing process, the retaining members 82a, 82b, etc., may be molded in an open form, shown in Figure 6(C) as well as the right-hand side of Figure 6(E). This open mold process is described above in connection with Figure 5(E) and is not repeated here.

[0057] To assist the placement of a catheter or guidewire within the slot, the tops of the slots in the retaining members 82a, 82b, as shown in Figure 6(C), may be configured to form an entry angle, such as the "V" as shown. The entry angle may be, e.g., 30-45 degrees and about 3 mm in depth; these values can vary widely. The entry angle may transition smoothly into the slit or groove in which the catheter or guidewire is held. In more detail, the retaining member 82a includes surfaces 81a, 81b, 83a, and 83b which form a wide "V" shape that may be used by a nurse or physician to conveniently locate the catheter or guidewire in the retaining member. The surfaces 81a, 81b, 83a, and 83b terminate at surfaces 85a, 85b, 87a, and 87b, which are generally the surfaces that engage with the catheter or guidewire. While shown as flat surfaces, these surfaces may be provided with a variety of curvatures to achieve various retaining effects, e.g., to provide extra retention power, lessened retention power, or the like. The surfaces 85a, 85b, 87a, and 87b may form a zero angle or may form a nonzero angle "a", which may be, e.g., 2- 10 degrees, e.g., 4 degrees. The force exerted by these surfaces on a catheter or guidewire may vary as the catheter or guidewire is pressed down into the retaining member. If the catheter or guidewire is inserted a small distance, less holding force will be exerted than if the catheter is inserted a large distance.

[0058] The holding force may be varied not just because of the taper or angle "a", but also because of the triangular shape (in cross-section) of the retaining member. That is, another way to vary the force is by the amount of retaining member holding the catheter or guidewire. As the catheter or guidewire is pressed down into the device, the amount of retaining member frictionally contacting the same is increased, increasing the holding force. This has a number of beneficial aspects.

[0059] In particular, sometimes a physician desires that the wire or catheter be held very tightly so that the same does not move; at other times, the physician desires to be able to slide the catheter back and forth for precise placement. For example, to open an artery, first a guidewire is threaded down the vessel. Then a catheter with a balloon or metal stent at its tip is threaded onto the wire and advanced into the artery to the target blockage. Often, more than one artery is treated. Very commonly, blockages form at branch points, so the operator has to insert two wires, one into each branch, and then thread two balloons or two stents over the two wires so that both wires and both balloons (or stents) are across both branches simultaneously. Before inflating the balloons (or deploying the stents), the operator needs to carefully advance and retract each balloon, while watching their positions on x-ray fluoroscopy, to get the devices in a precisely desired position. Often, a physician will push one balloon down the artery and, although not desired, the other moves down with it and vice-versa. In addition, it is difficult to remember which wire and catheter is going down which branch. Moreover, the wires and catheters may be inadvertently wrapped around each other, making changing out one catheter for another difficult, if not impossible. With the disclosed devices, an operator can push the wires all the way down into the slot so they are held tightly but keep the balloon or stent catheters at the top of the slot so they stay in position with respect to each other (but can still be moved in and out). [0060] Referring back to Fig. 6(A), the device 60 may include an attachment mechanism 113, shown in Fig. 6(A) as an assembly of opposing fingers. The assembly includes a first finger 122 separated by a substantially opposing finger 128. Distal ends of the fingers 122 and 128 are separated by a gap 132. A portion of one or both fingers 122 and 128 may include ribs 126 for ease in gripping. In the structure of Figure 6(A), only one finger (finger 122) (per set) is shown with ribs 126.

[0061] In use, a towel may be drawn into the gap 132 and held in place by frictional engagement with fingers 122 and 128. To remove, the gap 132 is made larger to allow the towel to escape the frictional engagement. In the configuration of Figure 6(A), one way to increase the size of the gap 132 is to push on the ribs 126, thereby deflecting a distal tip of the finger 122. Other ways of increasing the size of this gap will also be understood, given this teaching.

[0062] Other types of attachment mechanisms are disclosed below with respect to Figures 9-16.

[0063] Figures 7(A) - 7(F) illustrate a fifth embodiment 60 of a guidewire/catheter management device. In this embodiment, certain elements are similar to those described above with respect to Figures 6(A) - 6(E), and these elements have been given the same reference numerals and are not further described here.

[0064] In this fifth embodiment, the device 60 has a housing 61 with a top surface 48 from which extend vertically upward a number of supports 54a, 54b, etc. A number of retaining member housings 44a-44c are illustrated as mounted in the housing 61. A number of retaining members 46a-46f are illustrated mounted in the retaining member housings. In many cases, the retaining member housings may be formed integrally with the housing 61. As shown in Figure 7(C), the retaining members 46i may be inserted into the retaining member housings via snap-fit components 47 (shown in Figure 7(F)). Also as shown in Figure 7(F), the retaining members may be formed using the open mold process described above in connection with Figure 5(E), with the benefits appertaining thereto. Figure 7(F) also illustrates details of the slot and groove which are generally the same as described above in connection with Figures 6(C) - 6(E), are given corresponding (and primed) reference numerals, and are thus not further described here. Finally, Figures 7(D) and 7(E) illustrate a number of protuberances 115, which can serve to further secure the device to an operating table or to a towel draping a patient.

[0065] Figures 8(A)-8(E) illustrate a number of views of a sixth embodiment of a device 60' for catheter and guidewire management, having a housing 90 with vertical supports 91a-91g. In this device 60', retaining members 67a-67f with ribbed slots or grooves are employed. Certain elements are similar to those described above with respect to Figures 6(A) - 6(E), and these elements have been given the same reference numerals and are not further described here.

[0066] Details of the ribbed retaining members 67i are shown in Figures 8(E) - 8(G). The retaining member 67i includes fingers 72a and 72b. The finger 72a includes a rib 74a and an indentation 76a, while the finger 72b is shown with a rib 74b and an indentation 76b. The rib 74a fits into the indentation 76b while the rib 74b fits into the indentation 76a. In this way, a catheter or guidewire may be held even more securely, while minimizing the effects of "healing", described in greater detail below. Such retaining members 67i may be conveniently manufactured using the open mold process described above in connection with Figure 5(E).

[0067] It is noted that the materials constituting the retaining member may be, e.g., elastomeric materials such as a molded rubber or silicone. While the entire shape may be molded, in some implementations, knife slits may be made into the retaining members to form the surfaces described above. The durometer of the silicone or rubber may vary, e.g., in the range 30-80 Shore hardness, although this range is purely exemplary and other values are also possible. The materials constituting the housings and attachment mechanisms may be, e.g., an injection-molded plastic, silicone, or rubber. It will be understood that other materials are also contemplated. One aspect important in material choice is "healing", which is the tendency, especially of like materials, to adhere to each other upon constant contact, e.g., when stored for long periods of time. In the ribbed slot examples above, it may be desired to configure the same such that the ribs and indentations fit closely but do not touch, even when wires and catheters are removed. In this way, the amount of deleterious "healing" may be lessened. In addition, molded slits may be less susceptible to such healing. [0068] The slits of the retaining members may be such that they are about 1 cm apart, as well as 1-2 cm above the operating field, so as to not interfere with the physician's hand motions. Of course, these distances may vary widely depending on the application. While the retaining members are described as generally triangular in shape (in a cross- section viewed perpendicular to a plane bisecting the two surfaces 62a and 62b), it will be understood that any shape with a similar change in dimensions may be employed, e.g., parabolic or the like. Retaining members that are only substantially triangular are also envisioned. Retaining members may be used with just one slit or groove, and the entire device may have just one slit or groove; such embodiments may be particularly useful for temporary holding of guidewires or the like.

[0069] Figures 9(A) and 9(B) are perspective and side views, respectively, of a first embodiment of an attachment mechanism for attaching a device to a towel, e.g., as may be draping a patient during surgery, here implemented as a towel clamp with spring. In particular, a device 110 is illustrated that has a construction as described above with respect to any of the elongated member management devices. The device 110 is mounted to or formed integrally with an attachment mechanism, which in this case is a towel clamp with spring assembly 234. The towel clamp with spring assembly 234 includes an upper plate 36 and a lower plate 238 which are attached via a hinge assembly 244 which may include a spring 246. A pull tab 242 may extend from one extremity of the upper or lower plate (or both) for ease in attaching (and disengaging) the towel clamp from a towel T.

[0070] In use, a towel T is placed between the upper and lower plates. The spring forces the upper plate towards the lower one, frictionally securing the device 110 to the towel T. At any time, for installation or for removal, the pull tab 242 may be used to separate the upper from the lower plate.

[0071] Figures 10(A) and 10(B) are perspective and side views, respectively, of a second embodiment of an attachment mechanism for attaching a device to a towel, e.g., here implemented as a towel clamp with clip. In particular, a device 110 of the above- described construction is mounted on or formed integrally with an attachment mechanism, shown in Figure 10(A) and 10(B) as a towel clamp with clip 241. Some elements are the same as in Figure 9. For example, an upper plate 236 is coupled to a lower plate 238, and a pull tab 242 may extend from either (in Figure 10(A) and 10(B), from the upper plate). A hinge assembly 244 allows hinged movement of the plates. However, one of ordinary skill will recognize that the hinge assembly 244 is not necessary in all of these embodiments. For example, in Figure 10(A) and 10(B), the clip itself, as described below, may in some constructions be enough to hold the upper plate attached to the lower plate.

[0072] Referring again to Fig. 10(A) and 10(B), a clip 248 is shown, which holds the upper plate to the lower plate. The clip 248 may ride in an optional track 249 for ease of placement. An internal slot 254 may also be employed such that the clip 248 has a lower arm 251 that enters the lower plate. The internal slot 254 is only shown in Figure 10(B). It will be recognized that the track or internal slot may be employed on either the upper or lower plates, or both. However, in many implementations, it is easier to remove the clip if at least one plate does not employ an internal slot. For additional ease of installation and removal, a corrugation 252 may be disposed on an upper arm 247 of the clip 248. [0073] For installation, a towel T is placed between the upper and the lower plates and the clip loaded into the track and/or internal slot (or just around the plates if neither a slot nor a track is employed). Force applied in the direction F 1 secures the clip to the plates, and this secures the device 110 to the towel T.

[0074] Figures H(A) and H(B) are perspective and side views, respectively, of a third embodiment of an attachment mechanism for attaching a device to a towel, e.g., here implemented as a flexible fork assembly. In particular, Figure 11 shows a flexible fork assembly 256, which may be employed with (Figure H(A)) or without (Figure H(B)) a spring.

[0075] At least two tines 258 and 258' may form the fork 256. One or more tapered surfaces 260 and 260' may be employed to ease introduction of the towel portion into a hole 262 defined by the tines 258 and 258'.

[0076] In the implementation of Figure H(A), in use, the flexibility of the tines themselves may be configured to be enough to, upon installation of a towel portion, distend the tines and then bring the same back together to securely hold a towel. [0077] In a related implementation, that of Figure H(B), a flexible fork assembly 256' is shown including a spring 264 attached to the tine 258. In a related implementation, a spring may be attached to the tine 258' as well. In these implementations, the flexibility of the fork tines is assisted by the angular resilience of the spring.

[0078] In use, a towel portion may be inserted into hole 262, and the same may be conveniently inserted through the use of tapered surfaces 260 and 260'. Generally, a sufficiently-large portion of the towel is inserted so that a sufficient friction-fit is achieved, such that the towel does not pull out of the hole. This requirement can also be employed to set the minimum spring constant (or stiffness) of the spring 264, in implementations where this element is used.

[0079] Figures 12(A) and 12(B) are perspective and side views, respectively, of a fourth embodiment of an attachment mechanism for attaching a device 110 to a towel, e.g., here implemented as a flexible tab assembly 264. While the device 110 is not shown in the figure, the same may be mounted on, coupled to, or formed integrally with the attachment mechanism. The flexible tab assembly 264 includes at least two tines 266 and 266' as well as a flexible tab 268. A burr 270 may be formed on the flexible tab 268 to allow an enhanced gripping effect on a towel portion T. As shown in Figure 12(B), a towel portion T may be gathered and forced between the tines 266 and 266' and under the flexible tab 268. In this way, a towel may be secured in the flexible tab assembly 264, and thus the guidewire-loading device may be secured to a towel T. To release the towel, a force in the direction F2 may be exerted on the flexible tab 268.

[0080] Figures 13(A) and 13(B) are perspective and side views, respectively, of a fifth embodiment of an attachment mechanism for attaching a device 110 to a towel, e.g., here implemented as a hinged cover with a snap-button assembly 274. In particular, two opposing segments 276 and 276' define a hole 278 into which a towel (not shown) may be drawn. The hole 278 is shown as substantially circular, but the shape is not critical. The segments 276 and 276' may include respective tapered surfaces 280 and 280' to ease introduction of a towel into the hole 278. A hinged cover 282 is shown, which is attached to the segments 276 and 276' by a hinge 288. A neck 286 extends from the cover 282, and a snap button 284 is attached to the neck 286.

[0081] When a towel portion has been pulled through the hole 278, the cover 282 may be closed in the direction indicated by arrow F3. This action secures the towel in the hole 278 and thus secures the guidewire-loading device to the towel. In one implementation, as shown, the snap button 284 has a bulbous shape; this shape assists in the securing of the snap button within the hole. However, other shapes may also be employed. For removal, the user may pull up on the cover 282 to pull the snap button 284 out of engagement with the hole 278.

[0082] Figures 14(A) and 14(B) are perspective and side views, respectively, of a sixth embodiment of an attachment mechanism for attaching a device to a towel, e.g., here implemented as a sliding wire capture lock 290. As above, the same may be coupled to or formed integrally with a device 110. The sliding wire capture lock 290 includes a housing 91 in which are formed two slots 300 and 300'. A sliding wire 292 includes two longitudinal segments 294 and 294' which slide in the respective slots 300 and 300'. A cross segment 296 connects segments 294 and 294'. A tab 298 may be formed on the cross segment 296, to allow ease of pushing during installation and ease of pulling during removal. Ribbing, teeth, or other contouring may be employed on one or both sides of the tab 298 (as well as on a portion of the housing 291 facing the tab) to enhance the ability of a user to grip the tab 298 as well as to enhance gripping of a towel portion T. The tab 298 may extend along the any portion of the cross segment 296, include spanning the entire segment.

[0083] In use, a towel portion T is placed in the hole formed by segments 294, 294', 296, and the housing 291. The sliding wire 292 is then pushed toward the housing 291 in the direction indicated by arrow 302 (force F4). The towel T is thus captured, and the device 110 is thus secured to the towel T. For removal, the sliding wire 292 is pulled out in a direction opposite that of installation, and the towel T removed.

[0084] Figures 15(A) and 15(B) are perspective and side views, respectively, of a seventh embodiment of an attachment mechanism for attaching a device 110 to a towel, e.g., here implemented as a gripping ring assembly 304 with flexible fingers. This assembly 304 includes a housing 306 coupled to (or as above, integral with) the device 110 (shown in Figure 15(B)). A gripping ring 308 is formed in the housing, and the same includes a number of flexible fingers 308a, 308b, and so on. The gripping ring 308 and flexible fingers 308i may be formed of, e.g., various plastic or rubber materials in order to allow sufficient flexibility to receive a portion of a towel T, secure the same against removal during normal use, and allow the towel to be removed following use. In use, as shown in Figure 15(B), a portion of a towel T may be inserted into the gripping ring. The stiffness of the fingers 308i prevents removal of the towel until the procedure is completed, at which time the towel may be removed.

[0085] Figures 16(A) and 16(B) are perspective and side views, respectively, of an eighth embodiment of an attachment mechanism for attaching a device 110 to a towel, e.g., here implemented as a capture wire with engagement button assembly 110. The assembly 110 includes two supports 314 and 314' to which is mounted a capture wire 316. The supports 314 and 314' are mounted on a housing 313. Also mounted on the housing 113 is an engagement button 318 via a neck 320.

[0086] In use, a towel T is placed over the engagement button 318, and the capture wire 316 is then moved in an angular direction 312 and placed over the top of the towel T and the engagement button 318. The shape of the capture wire 316 and that of engagement button 318 may cooperate to secure the towel in position, or alternatively the securing may be accomplished only by way of friction fit with no particular shapes involved. To remove, the capture wire 316 is pulled away from the top of the engagement button 318, and the towel removed.

[0087] Suitable materials for use in major components of the attachment mechanisms are described above, as well as the device for catheter and guidewire management, include blow- or injection-molded plastics, or the like. The device for catheter and guidewire management may be single-use disposable or reusable.

[0088] The device may also be employed in a method for catheter and/or guidewire management. For example, in one exemplary method, the device for catheter and guidewire management may be employed to treat patients with "bifurcation lesions", i.e. the treatment of two vessels or branches simultaneously. Another application is a method of deploying rapid exchange catheters. When a rapid exchange catheter is first loaded on to a guidewire, the guidewire exits at the exit port, which is located about 22 cm from the catheter tip. An assistant holds the wire in place as the operator advances the catheter over the wire through the Y-adaptor and into the guide catheter towards the heart. Once the catheter has been advanced about 22 cm through the guide catheter, the portion of the guidewire external of the rapid exchange catheter is now confined by the guide catheter in such a way that the guidewire lies next to the catheter. The operator can now hold the wire with one hand while advancing the catheter with the other hand. In other words, for the first 22 cm, the assistant has to stop what they are doing and hold the wire in place for the operator. In a method employing a device for catheter or guidewire management, the device may be placed about 25 or 30 cm from the Y-adaptor. The rapid exchange catheter may be installed over the wire until the wire is emerging from the side of the catheter at the exit port and the catheter is about to enter the Y adaptor. The emerging portion of the guidewire may then be retained by any of the slits or grooves described, leaving the assistant free to perform other tasks. That is, the guidewire will then be held tightly by the slit so the catheter can be advanced through the Y-adaptor into the patient without the guidewire moving inside the artery. In some cases, two devices may then be used, one to retain the guidewire, and one to keep the multiple wires and catheters organized. Methods for installing other catheters will also be apparent given this disclosure.

[0089] While the particular invention as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages hereinbefore stated, it is to be understood that this disclosure is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended other than as described in the appended claims.

Claims

1. A device for managing associated pairs of flexible elongated members on a surgical field, said device comprising: a housing; means for holding said housing in a selected position and orientation on a surgical field; and at least one pair of retaining members disposed in the housing, each of the pair of retaining members being adapted to retain at least one flexible elongated member in a selected position.

2. The device recited in claim 1, wherein said housing further includes at least three vertical supports and at least two retaining member housings, each of the pair of retaining members configured to be disposed in a respective retaining member housing.

3. The device recited in claim 1, wherein each retaining member has two slots formed there, and wherein a taper of a first of the two slots is different from a taper of a second of the two slots.

4. The device recited in claim 3, wherein the taper of the first slot is configured for a catheter, and wherein the taper of the second slot is configured for a guidewire.

5. The device recited in claim 1, wherein a cross-sectional shape of at least one of said retaining members is substantially triangular.

6. The device recited in claim 1, wherein the retaining member has a durometer of between about 30-80 Shore hardness.

7. The device recited in claim 1, wherein the holding means includes an attachment mechanism coupled to the body, the attachment mechanism for securing the body to a fabric.

8. The device recited in claim 7, wherein the fabric is a towel for draping a patient.

9. The device recited in claim 7, wherein the attachment mechanism is selected from the group consisting of: towel clamps with springs or clips, flexible fork assemblies, flexible tabs, hinged tabs, wire capture systems, gripping rings with flexible fingers, wire-and-plug capture systems, at least one protuberance, and opposing finger towel capture systems.

10. The device recited in claim 9, wherein the attachment mechanism is an opposing finger towel capture system, and wherein an opposing finger towel capture system is disposed on at least two substantially opposite sides of the housing.

11. The device recited in claim 1, further comprising protuberances disposed on a bottom surface of the housing.

12. The device recited in claim 4, wherein said first slot includes at least two surfaces forming an angle of between about 2 and 10 degrees.

13. The device recited in claim 4, wherein said second slot includes at least two surfaces forming an angle of between about 0 and 2 degrees.

14. The device recited in claim 1, wherein the housing includes a bottom surface, and where at least a portion of the bottom surface is curved.

15. The device recited in claim 2, wherein the at least three vertical supports extend vertically upward from a top surface of the housing.

16. The device recited in claim 15, wherein the top surface is curved.

17. The device recited in claim 1, wherein each retaining member has two slots formed there, and wherein a shape of a first of the two slots is the same as a shape of a second of the two slots.

18. The device recited in claim 1, wherein the housing includes a bottom surface, and where at least a portion of the bottom surface is flat.

19. A device for managing associated pairs of flexible elongated members on a surgical field, said device comprising: a housing; at least one pair of retaining members disposed in the housing, each of the pair of retaining members including a first slot to accommodate a first flexible elongated member and further includes a second slot to accommodate a second flexible elongated member.

20. The device of claim 19, wherein the first slot is configured for a catheter, and wherein the second slot is configured for a guidewire.

21. A method for installing a rapid exchange catheter in a patient, comprising: installing a guidewire in a patient; threading a rapid exchange catheter onto the guidewire; securing the guidewire against movement, the securing including retaining the guidewire in a retaining device, the retaining device including: a housing; means for holding said housing in a selected position and orientation on a surgical field; and at least one retaining member disposed in the housing, the retaining member being adapted to retain at least one flexible elongated member in a selected position.

22. A device for managing a flexible elongated member on a surgical field, said device comprising: a housing; at least one retaining member disposed in the housing, the retaining member being adapted to retain at least one flexible elongated member in a selected position.

23. A method for manufacturing a device for wire management, comprising: molding a housing having at least two vertical supports; molding a retaining member having a slit or groove defined therein, the molding occurring such that the slit or groove is in a substantially open configuration; and compressing the retaining member and mounting the compressed retaining member between the at least two vertical supports.

24. The method of claim 23, further comprising molding an attachment mechanism with the housing.

25. The method of claim 23, further comprising attaching an attachment mechanism to the housing.