WO2001078824A1

WO2001078824A1 - Spool-type package for an elongate medical device

Info

Publication number: WO2001078824A1
Application number: PCT/US2001/005173
Authority: WO
Inventors: Robert F. Thompson
Original assignee: Scimed Life Systems, Inc.
Priority date: 2000-04-18
Filing date: 2001-02-16
Publication date: 2001-10-25
Also published as: AU2001238451A1

Abstract

A package (20) accommodates an elongate flexible medical device such as a catheter (10) or a guidewire. The package includes a package tray (22) and a spool (24) which is rotatably mounted on the tray for removably captively supporting the medical device which is wound around the spool. The rotatable movement of the spool with respect to the tray effects loading of the medical device onto the spool as well as dispensing the device from the spool. A removable outer cover (39) may be positioned over the tray for enclosing the spool and the medical device wound therearound.

Description

SPOOL-TYPE PACKAGE FOR AN ELONGATE MEDICAL DEVICE

FIELD OF THE INVENTION

The present invention relates generally to a package for accommodating an elongate medical device. More particularly, the present invention relates to a package which accommodates a catheter or guidewire wound on a spool held within an package tray.

BACKGROUND OF THE INVENTION

Medical devices used in various medical procedures must be accommodated in packaging which allows the medical personnel access to the device in a convenient fashion. These packages which contain medical devices must also maintain the devices in a sterile condition until the package is opened and the device is used.

Certain medical devices such as catheters and guidewires are particularly difficult to adequately package and maintain in a sterile environment due to their extended length and longitudinal flexibility. Various packaging techniques are currently used to support catheters and guidewires in various configurations. These prior packaging techniques include thermoformed trays, flexible pouches, die-cut paper board containers, extruded tubing and other packaging shapes which provide support and protection for these devices. However, many of these existing packages are cumbersome to use, in that it is difficult to load and remove the catheter or guidewire from the package. Further, many of these existing packages provide for poor containment of the device once the package is open. For example, certain of the packages support the catheter or guidewire in a rolled, coiled or compressed state. Once the package is opened, there is the risk that the catheter or guidewire may inadvertently spring out of the package and result in contamination of the device. Furthermore, certain of these packages are difficult to open. Quite often in an effort to secure the catheter or guidewire in the package, it may become difficult to easily remove the device from the package itself during the medical procedure. As may be appreciated, during such a medical procedure, it is necessary for the medical personnel to have quick and easy access to the device contained within the package. It is therefore desirable to provide a package for medical devices, especially elongate guidewires and catheters that are difficult to adequately package which, permits the device to be securely supported within the package yet allows the device to be easily and quickly removed from the package or used in a medical procedure.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a package for accommodating an elongate flexible medical device such as a guidewire or catheter. The package provides for the secure accommodation of the medical device in a sterile environment. The medical device may be easily loaded into the package and dispensed therefiOm.

In an efficient attainment of these and other objects, the present invention provides a package for an elongate flexible medical device such as a guidewire or a catheter. The package includes a package tray and a spool which is rotatably mounted on the tray for removably captively supporting the medical device which is wound around the spool. Rotatable movement of the spool effects loading of the medical device onto the spool as well as dispensing the medical device therefrom.

In preferred embodiments shown herein, the package tray includes a depression which accommodates the spool rotatably therein. The spool and the depression in the package define an annular cavity for supporting the elongate medical device in wound fashion. A detent structure is included on the spool to captively retain the medical device within the annular chamber once it is wound around the spool. A removable outer cover may be positioned over the tray for enclosing the spool and the medical device wound therearound.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective showing of the package assembly of the present invention including an elongate medical device supported therein.

Figure 2 shows the package of Figure 1 with the medical device removed. Figure 3 is an exploded perspective showing of the package of Figure 2 with the spool removed from the tray.

Figure 4 is a perspective showing of the tray of the package of Figure 3.

Figure 5 is a perspective showing of the spool of the package of Figure 3.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides a novel package for loading, dispensing and securing an elongate flexible medical device. The package may be easily and economically constructed and may secure the medical device within the package in a sterile environment. The package permits the easy dispensing of the medical device therefrom so that it may be used by medical personnel during a medical procedure.

Referring to Figures 1 and 2, the package of the present invention may be used to load, store and dispense an elongate, flexible medical device. In the present illustrative embodiment, the particular medical device as shown is a catheter 10 of the type commonly used in medical procedures. The catheter 10 includes a proximal end 12, a distal end 14 and a length of elongate flexible catheter tubing 16 therebetween. The proximal end 12 of catheter 10 includes thereat a Y-shaped adapter 18 secured to one end of the elongate tubing 16. Adapter 18 is of construction well known in the art which allows the catheter to be adapted for use with fluid through the proximal end 12. Also, as well known in the art, the adapter 18 may be used as a handle and as a port for entry of other functional equipment such as tools, probes, optics and the like. Also, as well known in the art, the catheter tubing 16 may be single or a multi-lumen tube and may include a balloon (not shown) or other operational device at the distal end 14 thereof. The distal end 14 may include a protective sleeve 19 which would overlie the balloon or other functional device supported at the distal end 14 of catheter 10.

In order to securely accommodate and to permit the easy loading and dispensing of catheter 10 for use in a medical applications, the present invention provides a novel package assembly 20. The package assembly 20 includes a package tray 22 and a spool 24 which is rotatably accommodated within tray 22. The tray 22 and the spool 24 may be formed of a wide variety of materials and from a wide variety of forming techniques. Preferably, the tray 22 and the spool 24 may be formed of a suitable plastic forming techniques such as extrusion, molding, machining, blow molding, die cutting, and the like. Plastic is a preferred material used for forming package assembly 20 as it is economical to form and easy to sterilize. Other materials, however, may also be used to form tray 22 and spool 24 of package assembly 20. Such materials may include formed metal, die cut paperboard, folded paperboard and the like.

Referring additionally to Figures 3 and 4, tray 22 is generally a planar rectangular member having opposed planar surfaces 22a and 22b. A tray depression 26 is formed into the upper surface 22a and extends below lower surface 22b. Depression 26 includes a spool receiving region 28 of generally shallow open-ended cylindrical configuration which accommodates in rotatable fashion spool 24 therein as will be described in further detail hereinbelow. Spool receiving region 28 is defined by a generally circumferential wall 30 extending from upper surface 22a toward a bottom wall 29 of depression 26. Spool receiving region 28 is further defined by a centrally positioned raised floor 29a.

Centrally located in spool receiving region 28 of depression 26 is an upstanding post 32 which extends from floor 29a. The post 32, as will be described in further detail hereinbelow, is designed to secure spool 24 within spool receiving 28 in rotatable fashion. The post 32 serves as an axle about which the spool rotates. Depression 26 further includes a circumferentially offset adapter receiving region 34 in communication with spool receiving region 28. Adapter receiving region 34 is configured so as to accommodate Y-shaped adapter 18 of catheter 10. As may be appreciated, the adapter receiving region 34 may be differently configured depending upon the type of medical device supported by package assembly 20.

The tray 22 further includes an upwardly raised permitrical rim 37 located about the periphery of upper surface 22a. Rim 37 may accommodate a flexible cover such as a plastic sheet like cover 39 which may be adhesively or heat secured to the rim to enclose the spool 24 and catheter 10 in a sterile environment. Alternatively, package assembly 20 can be used without cover 39, but enclosed in another container such as a bag or pouch (not shown) to contain the assembly in a sterile environment.

With additional reference to Figure 5, spool 24 is designed for rotatable accommodation within spool receiving depression 28 of tray 22. Spool 24 is generally a shallow cylindrical member having an upper surface 24a, a spaced apart lower surface 24b and a cylindrical side wall 36 extending therebetween. The lower surface 24b includes a radially outwardly extending circumferential ledge 38.

Centrally located on spool 24 is an open ended inverted cup-shaped hub 40. Hub 40 is constructed to receive upstanding post 32 of tray 22 so that spool 24 may be rotated thereabout. Hub 40 and post 32 may include a cooperating detent structure to removably captively retain post 32 within hub 40 yet permit rotation therebetween. In the present illustrative embodiment, post 32 includes an outwardly extending annular rib 32a which is received within an annular groove 40a of hub 40.

The upper surface 24a of spool 24 includes an elongate cord-like slot 44 extending thereacross. Slot 44, as will be described in further detail hereinbelow, is designed to accommodate the distal end 14 of catheter 10 therein and is configured to captively accommodate sleeve 19 disposed thereover. A plurality of inwardly directed protrusions 46 extend from the upper surface 24a and partially across slot 44 to captively retain sleeve 19 and distal end 14 of catheter 10 therein (Figure 1). Further, upper surface 24a of spool 24 includes a plurality of circumferentially spaced recesses 48 thereabout. Recesses 48 are interconnected by channels extending towards hub 40. The recesses 48 are provided to help permit the manual or mechanical rotation of spool 24 while the channels 48 are provided to facilitate the economical and efficient formation of the recess in a plastic molding process.

As may be appreciated and as more fully shown in Figures 1 and 2, spool 24 is positioned within spool receiving region 28 of tray 22. A snap fit arrangement is provided between upstanding posts 32 of tray 22 and hub 40 of spool 24. This snap fit arrangement allows rotation of spool 24 with respect to tray 22. When positioned as shown in Figure 2, the circumferential wall 30 of tray 22 and the cylindrical side wall of 36 of spool 24 form an annular region 42 therebetween. The annular region 42 is further defined by ledge 38 extending from spool 24. Annular region 42 accommodates coiled tubing 16 of catheter 10 as shown in Figure 1. In order to maintain coiled tubing 16 in captive retention within annular region 42, the upper surface 24a of spool 24 includes radially-outwardly extending protrusions 50 extending therefrom. Protrusions 50 overlie annular region 42 and help prevent tubing 16 coiled within annular region 42 from inadvertently dislodging therefrom. In order to assist in the retention of tubing 16 within annular region 42, annular depression wall 30 may include radially-inwardly extending protrusions 52 thereabout.

Having described the components of the package assembly 10 of the present invention, its use in loading, storing and dispensing an elongate medical device such as catheter 10 may be described.

Initially, the distal end 14 of catheter 10 including sleeve 19 thereover is inserted into cord-like slot 44. The sleeve 19 may be snap fitted past protrusions 46 in upper surface 24a of spool 24 which retentively accommodate the sleeve 19 therein. Cord-like slot 44 is in communication with annular region 42 formed between circumferential wall 30 and cylindrical side wall 36. The spool may be manually or mechanically rotated in a counterclockwise direction as shown in Figures 1 and 2 to effect winding of the catheter tubing about spool 24. The catheter tubing will remain securely retained within annular region 42 by the protrusions 50 outwardly extending from upper surface 24a of spool 24 and protrusions 52 inwardly extending from surface 22a of tray 22. Several rotations of spool 24 within tray 22 causes the tubing 16 to be completely wound about the spool 24. Thereafter, the adapter 18 may be snap fitted into adapter receiving region 34 of depression 26 so as to permit complete captive retention of catheter 10 within package assembly 20. Cover 39 is disposed over the upper surface 22a of tray 22 and is adhered to upstanding rim 36. The entire assembly may be sterilized and then provided in an outer package (not shown) for transportation and storage.

The package assembly 20 is removed from the outer packaging for use. In order to access the catheter 10, the cover 39 is removed from the upper surface 22a of tray 22. While the catheter is coiled, it will not have a tendency to spring out from package assembly 20 as the length of tubing 16 is captively retained within annular region 42. Medical personnel desiring to use catheter 14 remove the adapter 18 from adapter receiving region 34. Thereafter, the spool may be rotated manually in a clockwise fashion to dispense the catheter from spool 24. Such dispensement can be achieved by pulling on the adapter 18 thereby effecting rotation of spool 24 or by simultaneously effecting manual rotation of spool 24 using finger holes provided by recesses 48. While the recesses 48 facilitate manual loading and dispensing of the catheter, an appropriate automatic device may be employed to effect the rotation of the spool to load or dispense the catheter therefrom.

Although the illustrative embodiments of the present invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments, and that various other changes and/or modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the invention, and it is intended to claim all such changes and/or modifications as fall within the scope of the invention.

Claims

WHAT IS CLAIMED

1. A package for an elongate flexible medical device comprising: a package tray; and a spool rotatably mounted on said tray for removably captively supporting said elongate medical device wound therearound; wherein said rotatable movement of said spool effects loading said medical device thereonto and dispensing of said medical device therefrom.

2. A package of claim 1 when said tray and said spool define an annular cavity for accommodating said medical device.

3. A package of claim 2 when said package tray includes a depression formed therein and wherein said annular cavity is defined within said depression.

4. A package of claim 3 wherein spool includes detent structure thereon to removably captively retain said medical device within said annular chamber.

5. A package of claim 4 wherein said spool is rotatable within said depression in a first rotational direction to effect said loading of medical device onto said spool and further rotatable in a second rotational direction to effect said dispensing of medical device therefrom.

6. A package of claim 5 further includes a removable outer cover positionable over said tray for enclosing said spool and said medical device in said tray.

7. A package for loading and dispensing an elongate medical device having a distal tip, an elongate flexible body and a proximal portion comprising: a generally cylindrical spool having a circumferential surface for supporting said medical device wound thereon; and a package tray having an open-ended generally cylindrical region for insertably and rotatably accommodating said spool therein, said cylindrical region including a circumferential wall defining an annular channel with said circumferential surface of said spool for releasably captively retaining said medical device therein.

8. A package of claim 7 wherein said open ended region is defined by a depression formed in said tray.

9. A package of claim 8 wherein said spool includes spaced apart upper and lower surfaces with said cylindrical surface defined therebetween.

10. A package of claim 9 wherein said spool includes a slot formed in said upper surface and in communication with said annular channel wall for captively retaining said distal tip of said medical device therein.

11. A package of claim 10 wherein said spool includes projections radially outwardly extending from said upper surface so as to over lie said annular channel for retaining said flexible body of said device therein.

12. A package of claim 11 wherein said spool includes a plurality of longitudinally spaced spool projections extending from said upper surface and overlying said slot for captively retaining said distal tip therein.