MEDICAL DEVICE MANAGEMENT SYSTEM

Abstract

A medical device or catheter management system comprises several layers where a top layer has one or more channels to receive one or more elongated medical devices or members and a bottom layer comprises adhesive to secure the catheter management system to a patient or other secure site in the operating field. A firm upper surface causes the elongated medical devices or members to stay in the channels, whereas a firm inner layer facilitates maintaining the shape of the catheter management system and providing resistance for an operator to easily release an elongated medical device or member.

Claims

1. A sterile resistive medical holding unit capable of holding and releasing at least one elongated medical device or member, which comprises; an upper flexible substrate comprising at least one channel with at least one resistance component and a lower, adhesive surface, wherein rotation and translation of the elongated device or member can be controlled and the elongated device or member can be easily removed when sufficient force is manually applied to the elongated medical device or member to release the elongated medical device or member from the sterile resistive medical holding unit for additional manipulation.

2. The medical holding unit of claim 1 which is capable of holding and releasing elongated medical devices or members having different diameters.

3. The medical holding unit of claim 1, wherein the elongated medical devices or members are selected from the group consisting of catheters, leads, stylets, medical tubings, and guide wires.

4. The medical holding unit of claim 1, wherein the depth and width of each channel is sufficient to receive and hold an elongated medical device or member.

5. The medical holding unit of claim 1, wherein at least one channel is nonlinear or curvilinear.

6. The medical holding unit of claim 5, wherein a perpendicular resistance component is centrally located towards the concavity of the at least one channel to provide resistance to rotation and translation of each elongated medical device or member.

7. The medical holding unit of claim 1, in which two or more curvilinear channels are aligned in parallel to hold and release multiple elongated medical devices or members.

8. The medical holding unit of claim 7 in which the curvilinear channels may have variable widths, depths, and locations of perpendicular resistance components to control the resistance of a variety of elongated medical devices based upon their particular size.

9. The medical holding unit of claim 1, wherein each channel comprises at least one protrusion that extends from about 10 to about 90% perpendicularly across a channel.

10. The medical holding unit of claim 9, wherein each channel comprises at least one protrusion that extends from about 15 to about 80% perpendicularly across a channel.

11. The medical unit of claim 9, wherein each channel has at least two protrusions that alternatingly extend in opposite directions.

12. The medical holding unit of claim 1, wherein the upper flexible substrate is an injection molded polymer or rubber.

13. The medical holding unit of claim 1, wherein the upper flexible substrate contains labeling either imprinted on or formed as part of the molded structure, to help organize elongated medical devices or members.

14. The medical holding unit of claim 1, wherein the lower adhesive layer comprises a biocompatible adhesive material capable of holding the medical unit against a patient's skin, a sterile medical drape, a patient's clothing, or a flat surface, proximal to an insertion site of an elongated medical device.

15. The medical holding unit of claim 1 which comprises a slitter capable of slitting and removing an introducer sheath from an implanted pacing or defibrillation lead while maintaining the position of other previously implanted leads.

16. The medical holding unit of claim 15 which comprises an additional component contiguous to at least one channel opening which is capable of being inserted within an introducer sheath such that the introducer sheaths themselves can be easily removed while maintaining implanted lead or leads in their previously placed position.

17. The medical holding unit of claim 16, wherein the additional component is manufactured as an integral part of the holding unit or is a separate piece that can be attached and, optionally, removed.

18. An assembly of medical holding units of claim 1, wherein two or more medical holding units are arranged in parallel or in series, or in a combination thereof.

19. The assembly of claim 18, wherein two or more curvilinear channels are aligned in series to augment and enhance the resistant to the elongated medical device to prevent further rotation and translation of said elongated medical device or member.

20. The assembly of claim 18, wherein two or more medical holding units are arranged in parallel to hold and release multiple elongated medical devices.

21. The assembly of claim 18, wherein two or more medical holding units are arranged in series, such that more than one medical holding unit holds the elongated medical device or member to increase the resistive force on the elongated medical device or member to prevent further rotation and translation of the elongated medical device or member.

22. The assembly of claim 18 in which a series of medical holding units are arranged using both a parallel configuration to accept multiple elongated medical devices or members, together with a series configuration to further augment the resistance to the elongated medical devices or members and additionally prevent rotation and translation.

23. The assembly of claim 18, wherein two or more medical holding units have lateral surfaces that can be permanently or releasably adjoined to hold the medical holding units in place adjacent to each other.

24. The assembly of claim 18 which is capable of maintaining all inserted leads in position and allowing slitting of their introducer sheaths and removal of said sheaths.

25. A medical holding device for managing one or more elongated medical devices or members, comprising: a flexible substrate having one or more curvilinear channels each extending from a first surface to a second opposed surface, wherein the substrate has a flat or substantially flat bottom surface and one or more adhesive layers are attached to the bottom surface, and wherein each channel has a depth sufficient to receive an elongated medical device or member and the channel comprises curvature or one or more protrusions, substances, or protrusions and substances of releasably holding the elongated medical device or member.

26. The medical holding device of claim 25, wherein the substrate has two or more channels.

27. The medical holding device of claim 25, wherein each channel comprises at least one protrusion that extends from about 15 to about 90% perpendicularly across a channel.

28. The medical holding device of claim 25, wherein each channel has at least two protrusions that alternatingly extend in opposite directions.

29. The medical holding device of claim 25 which is elongated.

30. An assembly of two or more medical holding devices of claim 25, wherein more than one device is organized parallel to one another, and separated but perpendicular to the elongated medical devices or members to organize the elongated medical devices or members and/or their connector cables and prevent entanglement of said elongated medical devices or members.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0156] FIG. 1 is a schematic cross-sectional representation of an embodiment of the invention;

[0157] FIG. 2 is a schematic cross-sectional representation of another embodiment of the invention;

[0158] FIG. 3 is a schematic cross-sectional representation of a further embodiment of the invention;

[0159] FIG. 4 is a schematic oblique representation of an embodiment of the invention;

[0160] FIGS. 5 and 6 are each a schematic cross-sectional representation of another embodiment of the invention;

[0161] FIGS. 7A-7D are schematic representations of another embodiment of the invention, where FIG. 7D represents a medical holding unit comprising a substrate with an attached adhesive layer;

[0162] FIG. 8 is a schematic representation of the embodiment shown in FIG. 7D where the components are separated;

[0163] FIG. 9 is a schematic representation of an embodiment of the invention where the grooves or channels are in a “fan shape”;

[0164] FIGS. 10A to 10D are schematic representations of assemblies or modules according to the invention having two or more medical holding units;

[0165] FIG. 11 is a schematic representation of a system of the invention comprising a system of two elongated medical device or member management systems;

[0166] FIGS. 12A and 12B are top and lateral views, respectively, of an embodiment of the invention suitable to having a attached splitter assembly;

[0167] FIGS. 13A to 13D are schematic views of a splitter assembly attached to a substrate of a medical holding unit of the invention; and

[0168] FIG. 13D is a cross-sectional view of a splitter assembly.

DETAILED DESCRIPTION OF THE INVENTION

[0169] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced. It should be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0170] As shown in FIG. 1, a section 2 of a medical device or catheter management system according to the invention comprises a firmer upper surface or layer 4, a less firm middle layer 6, and a non-allergenic adhesive layer 8 comprising a substrate. A “wire” 10, such as a catheter, guide wire, lead, sheath, or other elongated medical device or member, is positioned at the opening or entrance 12 to a lateral groove, slit, slot, gap, or other opening, i.e., channel, 14 having inner surfaces 16. When the operator (not shown) presses downward on wire 12, upper surface sections 20 of layer 4 bend downward so that the middle layer 6 on each side of channel 14 is compressed. Then, wire 10 moves downward below sections 20, sections 20 recoil upward, and inner surfaces 16 compress wire 10, trapping wire 10. Surfaces 16 and middle layer 6 provide resistance, that is, they prevent movement while upper layer 4 holds wire 10 in. Catheter management system 2 as well as the other embodiments shown and described herein will preferably have a removable polymeric layer 22 covering the bottom of adhesive layer 8.

[0171] Removal of wire 10 is easy. From the side the operator applies upward pressure to wire 10 so that it is pushed up from section 2 and released for manipulation

[0172] In the embodiment of the invention shown in FIG. 2, a medical device or catheter management system 24 comprises a firmer upper surface or layer 26, a less firm middle layer 28, a lower layer 30, and a non-allergenic adhesive layer 34. Lateral grooves, slits, slots, or gaps or other openings, i.e., channels, 36 extend from upper layer 26 to the upper surface 38 of lower layer 30.

[0173] In the embodiment of the invention shown in FIG. 3, a medical device or catheter management system 44 comprises a firmer upper layer or surface 46, a less firm middle layer 48, a rigid layer 52, optionally a lower layer 54, and an adhesive layer 56. Lateral grooves, slits, slots, gaps, or other openings, i.e., channels, 60 extend from upper layer 46 to an upper surface 62 of rigid layer 52.

[0174] In FIG. 4, a medical device or catheter management system 70 has an upper layer 72 with an upper surface 74 upon which printing or other indicia 76, such as instructions, a warning, or a company name or logo, or any combination thereof, could appear. Whereas the grooves, slits, slots, gaps, or other openings, i.e., channels, 78 might normally be spaced uniformly across upper surface 74, optionally channels 78 may be positioned so that there is a larger upper surface for such indicia. Also, two or more of channels 78 may be parallel or non-parallel. For example, channels 78 may be arranged in a fan shape.

[0175] The medical device or catheter management systems set forth in FIGS. 5 and 6 represent additional embodiments of the invention. In FIG. 5, a system 90 has a first layer 92 with an attached upper layer or surface 94 comprised of material firmer than the material of first layer 92. First layer 92 is attached to second layer 95, which is in turn attached at boundary 96 to a firmer third layer 98. The lower surface of third layer 98 is attached at boundary 100 to a fourth, adhesive layer 102. Adhesive layer 102 has a surface 104, preferably curved, that comprises adhesive or other chemical or mechanical means for bonding with a patient's skin or clothing or with a drape or other flexible or hard surface in an operating room or medical facility (not shown).

[0176] Upper layer or surface 94 can be coextensive with the upper boundary 112 of first layer 92 or the lateral edges 108 of upper layer or surface 94 can extend into a channel 110 as shown in FIG. 5 or be withdrawn or recessed from channel 110 as shown in FIG. 6.

[0177] As can be seen, channel 110 can be wider at its top 114 than at its bottom 120, as in FIG. 5, or narrower at its top 114 than at its bottom 120, as in FIG. 6. Optionally, as shown in other embodiments, the sides of channel 110 can be substantially parallel.

[0178] Although first layer 92 and second layer 95 are depicted as two separate components, it is within the scope of the invention that first layer 92 and second layer 95 can form a single continuous unit, element, or component of the same material.

[0179] Overall the medical device or catheter management systems of the invention described above comprise firm but flexible material. Upper layers 4, 26, 46, 72, and 94 and rigid layers 52 and 98 comprise a rigid or semi-rigid polymeric material such as a polycarbonate. Useful polymeric materials include, but are not limited to, LEXAN® polycarbonate materials available from GE Plastics.

[0180] Middle layers 6, 28, 48, and 95 comprise a less rigid, more resilient polymeric material such as a polyacetate, polycarbonate, or polyethylene foam. Useful polymeric foams include, but are not limited to, ethylene vinyl acetate and many of the polychloroprene synthetic rubbers available as Neoprene from DuPont. Lower layers 30 and 54 preferably comprise a polymeric material that is less resilient than the middle layer, such as a polycarbonate. Useful polymeric materials for this layer include, but are not limited to, LEXAN® polycarbonate materials.

[0181] Adhesive layers 8, 34, 56, and 102 comprise pre-formed adhesive tape that is sticky on both the upper and lower surfaces and has peel away protective tape on both surfaces. One surface is exposed when the catheter management system is assembled; the other surface is exposed when the catheter management system is applied to a desired surface. Examples of adhesive tapes or substrates that are useful include 3M's 1587 and 1772 contact adhesives, which have a 1/16″ polyethylene foam substrate. Alternatively, direct adhesive could be applied to the bottom surface with protective peel off tape with a tab to provide easy removal.

[0182] Individual layers are bound together by an appropriate medical grade adhesive. 3M's 1510 acrylic adhesive has been useful in this regard. In addition, individual layers can be adhered together by heat or other chemical or mechanical means.

[0183] Optionally the medical device or catheter management system could have two or more flat tabs to provide surfaces to which surgical clamps can be attached, to hold the pad, for example, on a surgical drape. In addition, the bottom adherent surface could be a VELCRO® component or clip.

[0184] With regard to grooves, slots, gaps, slits, channels, or other openings in the upper surface of the catheter management system, a groove, slot, gap, slit, channel, or other opening can be pushed open, and a catheter, guide wire, sheath, lead, or other elongated medical device or member can be inserted laterally into the groove, slot, gap, slit, channel, or other opening, which will then close back around the catheter, guide wire, sheath, lead, or other elongated medical device or member and hold it in place, to prevent movement in the transverse or axial direction.

[0185] The depths of the various layers can vary according to the application and materials. Typically the upper layers 4, 26, 46, 72, and 94 will each be from about 0.3 mm to about 0.7 mm thick, and the middle layers 6, 28, 48, and 92 will each be from about 0.1 cm to about 0.5 cm thick. Lower layers 30, 54, and 95 will each be from about 0.1 cm to about 0.3 cm thick, and adhesive layers 8, 34, 56, and 102 will each be about 0.1 cm to about 2.5 cm thick. Channels 14, 36, 60, and 110 can be from about 0 mils (a slit) to about 30 mils wide, preferably from about 20 to about 30 mils wide (what are termed gaps). Channels 14, 36, 60, and 110 are preferably from about 1.5 cm to about 2.0 cm apart, but this can vary, according to the operator's wishes, habits, or desires. Additional sizes and dimensions could be configured for microsurgical applications as well as macrosurgery.

[0186] The grooves, slits, slots, gaps, channels, or openings can vary in shape and size to accommodate catheters, guide wires, leads, sheaths, or other medical devices or members, which have different diameters. However, thin slits in the above design can accommodate a variety of elongated medical device or member sizes and shapes due to the material engineering design (firm but malleable upper layer and softer lower layer or some variation thereof).

[0187] The dimensions of the medical device or catheter management system described above can vary greatly due to the intended application and the number of “wires” that may be used. In one embodiment of the invention, the substrate may have a length of from about 0.5 to about 10.0 inches, a width of from about 0.2 to about 5.0 inches, and a thickness of from about 0.1 to about 0.5 inches.

[0188] It is within the scope of the invention that a medical device or catheter management system, that is, a sterile disposable multilayered device for managing catheters, guide wires, leads, sheaths, or other medical devices, can be more simply viewed as a two component system. As a first component, an upper component has upper and lower surfaces, wherein one or more lateral grooves, slots, channels, or gaps extend from the upper surface of the upper component into the upper component. The second component comprises means of, attaching, optionally releasably attaching, to a desired location on or near a patient. One or more catheters, guide wires, leads, sheaths, or other medical devices or members can be positioned in the grooves, slots, or gaps to maintain position relative to each other and then easily be removed.

[0189] The first component may comprise the one or more layers described above, where the first component may have firm, soft, and then firm layers, or firm, soft, soft, and firm layers. Moreover, whereas there may two adjacent layers that could be the same material, there may in fact only be one layer, for example, one where the gaps, grooves, or slots do not go through the entire combined layer but only to a depth consistent with what may have been the first upper layer.

[0190] In another embodiment of the invention, a sterile resistive medical holding unit is capable of holding and releasing at least one elongated medical device or member. The medical holding unit comprises an upper flexible substrate comprising at least one channel with at least one resistive component and a lower adhesive surface or layer. The rotation and/or translation of each elongated medical device or member can be controlled, and each elongated medical device or member can be easily removed from the medical holding unit when sufficient force is manually applied to the elongated medical device or member to release the elongated medical device or member from the medical holding unit for additional manipulation.

[0191] The depth and width of each channel is sufficient to receive and hold an elongated medical device or member. The resistive component characteristic of a channel that holds an elongated medical device or member can be mechanical, such as a particular configuration, or chemical, such as a mild adhesive or other tacky substance. For example, a channel could be nonlinear or curvilinear with one or more protrusions or curves that provide a force perpendicular to the longitudinal axis of the elongated medical device or member, to cause the elongated medical device or member to fit snugly in the channel. The perpendicular resistive component provides resistance to rotation or translation, or both, of the elongated medical device or member. The channels may have variable widths, depths, and locations of the perpendicular resistance components to control the resistance of a variety of elongated medical devices or members based upon their particular size. For example, a channel may have one or more protrusions that each extend perpendicularly from about 10 to about 90%, preferably from about 15 to about 80%, more preferably from about 20 to about 60%, across the width of a channel.

[0192] Each holding unit may comprise one or more linear, nonlinear, or curvilinear channels, each with at least one perpendicular resistance force component. The channel cross-sections may be rectangular, rounded, square, triangular, or any shape that permits entry and release of an elongated medical device or member. Preferably the cross-sections are substantially similar within the holding unit, but they may vary. The perpendicular resistance force components must work by holding the elongated medical devices or members without deforming them or impairing their functionality, such as, for example, by kinking or otherwise impairing the flow of liquid. The perpendicular resistance force components do not need to be one to a channel but could be more than one or may even be a lip on a channel. They do not need to be perpendicular in direction or shape, they only need to impart a significant force equal to and opposite that of any rotational or translational force that may be applied to the elongated member when they are intended to be held in place. When an active perpendicular resistance force component is applied to the elongated medical device or member in these holding units, it must exceed and overcome this passive perpendicular resistance force component to release it from the channel. The perpendicular resistance force components could be balls, cylinders or rods, boxes, or any such shape that imparts a force to the elongated medical device or member and prevents rotation or translation of the elongated member once in the channel. The degree of channel impingement, as well as the perpendicular resistance force components own flexibility, may be important features in this.

[0193] A multiple elongated member holding, or holding and releasing, assembly or module is defined as a collection of, that is, two or more, medical holding units such that when they are aligned perpendicular to, or in the direction of, the direction of at least one elongated medical device or member they can handle more than one elongated medical device or member simultaneously

[0194] An augmented elongated medical device or member holding unit is defined as two or more holding units arranged so that units with essentially coextensive channels attach serially to an elongated medical device or member to amplify the holding properties above and beyond a single holding unit.

[0195] A medical holding unit according to the invention may comprise one or more channels and may be used by itself or spaced apart from another medical holding unit. It is within the scope of the invention that two or more medical holding units may be permanently or releasably attached to one another for use in desired situations. For example, two medical holding units each having a single channel or more than one channel could be attached to each other so that the channels are coextensive and an elongated medical device or member would extend from one channel immediately into another channel in the other holding unit. Such an arrangement would provide increased holding force to hold an elongated medical device or member in position. Alternatively, a medical holding unit having two parallel channels may be attached to a medical holding unit having only one channel that would then be coextensive with only one channel of the first medical holding unit. Similarly, medical holding units having the same or different numbers of channels can be assembled in whatever combination is necessary for the one or more elongated medical device or member being held.

[0196] It is within the scope of the invention that the medical holding units can be permanently or releasably attached to one another. For example, the medical holding units could be glued together in a desired configuration with a conventional medical grade adhesive, or lateral surfaces to the medical holding units could have adhesive patches covered by removable strips. In another embodiment, the medical holding units may have physical structure such as protrusions and reciprocal receiving structure such as slots so that the medical holding units can be assembled as desired, similar to LEGO building blocks or other instances where holding units can be snapped or locked together. Other physical attachment useful here would include VELCRO® materials or any other snaps, hooks, or the like that would hold the holding units together.

[0197] In the embodiment of the invention shown in FIGS. 7A to 8, a medical holding unit 140 comprises a substrate 142 with one or more grooves or channels 144. Each channel 144 extends from one lateral side 146 to another opposed lateral side 148 and has a depth and width sufficient to receive an elongated flexible medical device (not shown).

[0198] An upper surface 152 of an adhesive layer 154 adheres to a bottom surface 156 of substrate 142. An upper surface 160 of a removable flexible substrate 162 adheres to a bottom surface 164 of adhesive layer 154. Adhesive layer 154 may form a tab 158, as shown in FIG. 7D.

[0199] Each channel 144 is dimensioned and/or configured to be capable of releasably holding an elongated medical device or member (not shown). In FIGS. 7A, 7B, 7D, and 8, each channel 144 has at least one protrusion 166 that is capable of engaging an elongated medical device or member (not shown) to releasably hold it, where the channel is also defined by formed ridge 168. Alternatively, there could be two or more protrusions 166 extending alternatingly in opposite directions or another physical arrangement to releasably hold an elongated medical device or member. Optionally, protrusions 166 may have letters or numbers 150 to identify a channel for a particular elongated medical device or member (not shown). In another embodiment of the invention, a channel 144 could comprise a tacky substance alone or in combination with one or more protrusions.

[0200] Preferably channels 144 are substantially uniform in cross-section from one lateral side to the opposed other lateral side for a particular channel, although each channel 144 on a substrate 142 does not necessarily have the same depth or cross-section or longitudinal shape.

[0201] As shown in the lateral view of FIG. 7B, substrate 142 optionally may be slightly curved to better fit on a curved surface, such as a patient's leg, arm, or torso. Since substrate 142 is comprised of a flexible material, it will also fit a flat or substantially flat surface

[0202] In another aspect of the invention, as set forth in FIG. 9, a medical holding unit 170 may be slightly curved and the grooves or channels 172 may be in a “fan shape.”

[0203] In another embodiment of the invention, a catheter management assembly or module 202 shown in FIG. 10A may comprise a medical holding unit 204 with channels 206 and a medical holding unit 208 with channels 212, to substantially increase the rotational and translational holding ability, for example, with regard to holding catheter 214. Medical holding units 204 and 208 may be separate members that are permanently or removably affixed to one another by glue or mechanical means or they may be manufactured as one continuous unit. For example, medical holding unit 208 has openings 240 to receive projections 242, as shown on medical holding unit 204.

[0204] Each medical holding unit may have more than one channel, and assembly or module 202 may comprise more than two medical holding units, as shown in assembly 218 in FIG. 10B. Medical holding units 216, 220, and 222 have channels 224, 228, and 230, respectively, to hold a catheter 232. It is within the scope of the invention that different medical holding units having different numbers of channels may be attached to one another to form an assembly or module.

[0205] In another embodiment of the invention, a catheter management assembly or module 302 shown in FIG. 10C may comprise a medical holding unit 304 with a channel 306 and a medical holding unit 308 with a channel 312, to substantially increase the rotational and translational holding ability, for example, with regard to holding catheter 314. Medical holding units 304 and 308 may be separate members that are permanently or removably affixed to one another by glue or mechanical means or they may be manufactured as one continuous unit, or snapped together as in FIG. 10A.

[0206] Each medical holding unit may have more than one channel, and assembly or module 302 may comprise more than two medical holding units, as shown in FIG. 10D. Medical holding units 316, 320, and 322 have channels 324, 328, and 330, respectively, to hold a catheter 332. It is within the scope of the invention that different medical holding units having different numbers of channels may be attached to one another to form an assembly or module.

[0207] In another aspect of the invention, there may be two or more medical device or catheter management systems or medical holding units arranged, for example, in parallel, about 1 to about 3 feet apart, to manage and separate two or more catheters, guide wires, sheaths, leads, or other elongated medical devices or members. See, for example, FIG. 11, where two substrates 350, 352 are arranged in parallel about two feet apart to manage catheters 354, 356.

[0208] It is within the scope of the invention that a medical holding unit or any assembly thereof may have a component that functions as a splitter to split, for example, a catheter, sheath, or lead. FIG. 12A is a top view, and FIG. 12B is a side or lateral view, of a medical holding unit 402 having a substrate 404 with three channels 406 and protrusions 408. Each of protrusions 408 has a letter, formed in a mold or applied to the protrusion, to identify an elongated medical device or member. A tab 412 of a flexible material 414 is attached to an adhesive layer 416 on the bottom surface 418 of substrate 404.

[0209] The lateral longitudinal surfaces 422 of substrate 404 each have a longitudinally extending ridge 424 for engagement by elements of a splitter assembly. Alternatively, ridges 424 could be channels or tracks.

[0210] FIG. 13A is a top view of a clear plastic splitter assembly 430 that has been snapped into position on top of a substrate 432 with channels 434 having elongated medical devices or members 438, 440, 442, such as leads or sheaths, positioned therein. For example, the elongated medical devices 438, 440, and 442 could be a right ventricular lead, a left ventricular lead, and a right atrial lead, respectively. Splitter 324 puts pressure from above on elongated medical devices 438, 440, and 442. Splitter assembly 430 has one or more, preferably one, metal cutting component 446 for cutting a catheter, sheath, or lead.

[0211] As shown in a front view of FIG. 13B, with a cross-sectional view of elongated medical devices 438, 440, 442, connectors 448 of splitter assembly 430 engage one of the ridges 424 of substrate 404. Similarly, as shown in the rear view of FIG. 13C, connectors 452 engage a ridge 424. Connectors 546 each have a tab to facilitate bending the splitter assembly 458 at ridge 424.

[0212] A cross-sectional view of splitter assembly 430 is shown in FIG. 13D, with a tab 456 and a rear tab 460. The rear tabs are lower than the front tabs to help bend the splitter assembly over ridge 424. The tabs form hooks, and a center blade 470 is positioned for splitting.

[0213] The splitter assembly is preferably made from a firm but flexible, preferably clear, polymeric material. The splitter assembly may have indentations that correspond to the elongated medical devices or members. Also, the splitter assembly may be configured to be essentially any functional member that can attach to a holding unit and have a blade, hook, or other sharpened structure or other sharp component to split a sheath, catheter, or lead. This would include, for example, a sharpened blade that could be inserted into a hole or slot within the substrate itself.

[0214] Substrates of the medical device or catheter management systems described herein, especially in FIGS. 7A to 8, comprise a firm but flexible material, such as a silicone, cross-linked polydimethylsiloxane, or polysiloxane. Useful polymeric materials include, but are not limited to, SILASTIC® elastomers, available from Dow Corning.

[0215] An adhesive layer herein, such as adhesive layer 154, preferably comprises pre-formed adhesive tape that is sticky on both the upper and lower surfaces and has peel away protective tape (not shown) on both surfaces. One surface is exposed when the medical device or catheter management system is assembled; the other surface is exposed when the medical device or catheter management system is applied to a desired surface. Examples of adhesive tapes or substrates that are useful include 3M's 1587 and 1772 contact adhesives, which have a 1/16″ polyethylene foam substrate. Alternatively, direct adhesive could be applied to the bottom surface with protective peel-off tape with a tab to provide easy removal.

[0216] Channels of the substrates, such as channels 144, can be from about 0.2 to about 3.0 cm wide or deep, preferably from about 0.25 to about 2.0 cm wide or deep. This can vary, according to the operator's wishes, habits, or desires. Additional sizes and dimensions could be configured for microsurgical applications as well as macrosurgery.

[0217] The dimensions of the medical device or catheter management system or medical holding unit set forth in the drawings, especially in FIGS. 7A to 8, can vary greatly due to the intended application and the number of elongate medical devices that may be used. In one embodiment of the invention, the medical holding unit may have a length of from about 0.5 to about 10.0 inches, a width of from about 0.2 to about 5.0 inches, and a thickness of from about 0.1 to about 0.5 inches.

[0218] In one embodiment of the invention, the medical device or catheter management system or medical holding unit may comprise predetermined sizes of perhaps from about 2 to about 16, preferably from about 4 to about 12, inches in length. Optionally the catheter management system or medical holding unit may comprise longer lengths that can be cut to size, dependent upon the number of expected elongated medical devices or members. Alternatively, the medical device or catheter management system could be perforated or otherwise frangible at regular or irregular intervals so that lengths of useful size can be cut or torn off.

[0219] 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.