Guidewire loader apparatus and method

A guidewire loader apparatus is provided for loading a guidewire into a lumen opening of a guidewire lumen of a medical device. The loader apparatus includes a first member defining a respective medical device receiving portion and a respective guidewire receiving portion in communication therewith via a respective interface portion. The loader apparatus further includes a second member configured for placement in an opposed relationship to the first member. The second member defines a respective medical device receiving portion and a respective guidewire receiving portion in communication therewith at a respective interface portion. The first member and the second member cooperatively associate with one another between a first position and a second position. In the first position, the medical device can be positioned into at least one respective medical device receiving portion. In the second position, the respective device receiving portions cooperate to align and support the medical device in a manner placing the lumen opening of the medical device substantially adjacent to the cooperating, respective interface portions. This permits aligned sliding receipt of an end of the guidewire into the cooperating, respective guidewire receiving portions, through the cooperating respective interface portions and into the lumen opening of the medical device.

FIELD OF THE INVENTION

The present invention relates to medical devices in general, and in particular to a device for facilitating the loading of guidewires into medical devices.

BACKGROUND OF THE INVENTION

As an alternative to invasive-type surgeries whereby a physician creates an incision to access a desired location in the patient's body, many minimally invasive surgeries and in vivo examinations are being performed using catheters that are inserted into a patient's body. With a catheter in place, medical devices are routed through a lumen in the catheter in order to obtain tissue samples, perform a surgical procedure or diagnose tissue in a patient's body.

To insert a catheter, many physicians first use a guidewire that is routed to a desired location in the patient's body. The guidewire then acts as a rail over which catheters or other medical devices can be easily routed to the desired location.

Typically medical devices for insertion within a patient have a guidewire lumen extending through at least a portion thereof. Generally, the guidewire lumen is sufficiently sized to allow the device to pass over the guidewire freely. General diameters for guidewires are 0.014 to 0.038 inches, therefore the corresponding guidewire lumen must be sized accordingly.

To route a medical device over the guidewire, the guidewire must be inserted into a guidewire lumen of the medical device. Routing the guidewire into the guidewire lumen proves to be difficult for many reasons. For example, many times the tip of the catheter is formed having a curved shape wherein the guidewire lumen is coaxially disposed within the curve. Therefore, in order to dispose the guidewire into the lumen, the operator must straighten the curled tip of the catheter while simultaneously inserting the guidewire. This process may be further complicated by coatings applied to either the guidewire or the catheter, or both, which may make the surfaces slippery thereby hindering the process.

Further still, many modern guidewires include tips of differing flexibilities at their proximal and distal ends, thereby giving the physician the option of adjusting the flexibility depending on which end of the guidewire is inserted into the patient. However, such flexible tips are difficult to use with catheters because they are not stiff enough to be easily disposed within the guidewire lumen without severely bending and possibly kinking the catheter. Therefore, there is a need for a device that helps align and load a guidewire into a guidewire lumen of a medical device.

SUMMARY OF THE INVENTION

To address the above-mentioned problems, the present invention provides a tool for aligning and facilitating insertion of a guidewire into a guidewire lumen of a medical device. The tool includes a handle having a portion sized to receive a medical device therein and a lumen aligned with the medical device receiving portion to direct a guidewire into a lumen. The lumen may further include a tapered portion on each end to ease engagement of the medical device and the guidewire.

In one exemplary embodiment of the invention there is provided a guidewire loader, comprising a first member and a second member, the first and second members are spaced apart and connected about a hinge member. Each member further includes a medical device receiving portion and a guidewire receiving portion adjacent the hinge member.

In another specific embodiment, a guidewire loader apparatus is provided for loading a guidewire into a lumen opening of a guidewire lumen of a medical device. The loader apparatus includes a first member defining a respective medical device receiving portion and a respective guidewire receiving portion that terminates at the device receiving portion at a respective interface portion. The loader apparatus further includes a second member configured for placement in an opposed relationship to the first member. The second member defines a respective medical device receiving portion and a respective guidewire receiving portion in communication therewith at a respective interface portion. The first member and the second member cooperatively associate with one another between a first position and a second position. In the first position, the medical device can be positioned into at least one respective medical device receiving portion. In the second position, the respective device receiving portions cooperate to align and support the medical device in a manner placing the lumen opening of the medical device substantially adjacent the cooperating, respective interface portions. This permits aligned sliding receipt of an end of the guidewire into the cooperating, respective guidewire receiving portions, through the cooperating respective interface portions and into the lumen opening of the medical device.

In one particular configuration, each respective guidewire receiving portion is semi-conical-shaped, tapering inwardly toward the respective interface portion. Further, each respective medical device receiving portion is semi-cylindrical-shaped.

Each the first member and the second member include a respective base portion configured for placement in an opposed relationship to one another. Each respective base portion defines the respective device receiving portion, the guidewire receiving portion and the interface portion. A respective manipulating tab is provided to enable manual operation between the first position and the second position.

In one specific embodiment, each respective manipulating tab is configured for placement in opposed relationship to one another, and extend radially away from an longitudinal axis of the respective device receiving portion. The loader apparatus further includes a hinge portion hingeably mounting the first member to the second member for clamshell movement of the respective base portions between the first position and the second position.

Another specific arrangement provides a manipulating tab of the second member that includes a pair of opposed clip members hingeably mounted to the respective base portion on opposed sides of a longitudinal axis of the respective medical device receiving portion. One end of each clip member contains a respective grip portion, and an opposite end thereof contains a clip portion configured to releasably grip a corresponding clip region of the first member when the loader apparatus is in the second position.

In still another specific configuration, each the first member and the second member have a substantially planar engaging face in opposed relationship with one another in the second position. Each engaging face defines the respective medical device receiving portion, the respective guidewire receiving portion and the respective interface portion.

Another specific configuration includes alignment structure which cooperates between the first member and the second member to align the respective medical device receiving portions, the guidewire receiving portions and the interface portions with one another, when the first and second member are oriented in the second position. In one embodiment, the alignment structure includes an alignment lip upstanding from one of the engaging faces, and peripherally surrounding at least a portion of the respective medical device receiving portion, the guidewire receiving portion and the interface portion. The alignment structure further includes a corresponding alignment recess downstanding from the other of the engaging faces, and peripherally surrounding the other of the at least a portion of the respective medical device receiving portion, the guidewire receiving portion and the interface portion.

In another specific embodiment, the first member further defines a respective second guidewire receiving portion in communication therewith at a respective second interface portion. The second member further defines a respective second guidewire receiving portion in communication therewith at a respective second interface portion. In the second position, the respective device receiving portions cooperate to align and support the medical device in a manner placing a second lumen opening of a second guidewire lumen of the medical device substantially adjacent the cooperating, respective second interface portions. This permits aligned sliding receipt of an end of a second guidewire into the cooperating, respective second guidewire receiving portions, through the cooperating, respective second interface portions and into the second opening of the second guidewire lumen of the medical device.

Each respective guidewire receiving portion and second guidewire receiving portion is semi-conical-shaped, tapering inwardly toward the respective interface portion, and each respective medical device receiving portion is semi-cylindrical shaped. In one embodiment of the guidewire loader, the first and second members have respective cavities that define catheter receiving portions. The first and second elements may also be clamped together by mirror image clips on opposite sides of the first and second members. The first and second elements or portions thereof may be made from transparent material. In still another embodiment, the interface portion includes smooth interiors without a stepped transition, and optionally a manipulating tab extends from the respective base portion in a direction generally parallel to the longitudinal axis of the loader and catheter.

In another aspect of the present invention, a method is provided for loading a guidewire into a lumen opening of a guidewire lumen of a medical device. The method includes orienting at least one of a first member and a second member in a first position, enabling access to a respective engaging face of the at least one of the first member and the second member. The engaging face defines a respective medical device receiving portion and a respective guidewire receiving portion in communication therewith at a respective interface portion. In the first positioned, loading the medical device into a respective medical device receiving portion of the at least one first member and second member in a manner positioning the lumen opening thereof substantially adjacent the respective interface portion. The method further includes gripping and aligning the medical device between the first member and second member, in a second position. In this position, the first and second members are oriented in opposed relationship to one another such that the opposed guidewire receiving portions collectively form a guidewire receiving feature. Similarly, the opposed medical device receiving portions collectively form a medical device receiving feature that cooperatively aligns and supports the lumen opening of the medical device substantially adjacent the cooperating, respective interface portions. Next, the method includes inserting an end of the guidewire into the guidewire receiving feature, through the cooperating, respective interface portions and into the lumen opening of the medical device

DETAILED DESCRIPTION

While the present invention will be described with reference to a few specific embodiments, the description is illustrative of the invention and is not to be construed as limiting the invention. Various modifications to the present invention can be made to the preferred embodiments by those skilled in the art without departing from the true spirit and scope of the invention as defined by the appended claims. It will be noted here that for a better understanding, like components are designated by like reference numerals throughout the various figures.

Referring now to a first embodiment ofFIGS. 1-3and a second embodiment ofFIGS. 4-7, a guidewire loader apparatus, generally designated20, is provided for loading a guidewire21into a first lumen opening22of a first guidewire lumen23of a medical device25. The guidewire loader apparatus20includes a first member26adefining a respective medical device receiving portion27aand a respective first guidewire receiving portion28ain communication therewith via a respective first interface portion30a(FIGS. 2 and 7). A second member26bis also provided that is configured for placement in an opposed relationship to the first member26a(FIGS. 1 and 4). The second member26bdefines a respective medical device receiving portion27band a respective first guidewire receiving portion28bin communication therewith at a respective first interface portion30b(FIG. 8).

The first member26aand the second member26bcooperatively associate with one another between a first position (FIGS. 2 and 5) and a second position (FIGS. 3 and 4). In the first position, the medical device25can be positioned into at least one respective medical device receiving portion27aor27b. In the second position, the respective device receiving portions27a,27bcooperate to align and support the medical device25in a manner placing the first lumen opening22thereof substantially adjacent the cooperating, respective first interface portions30a,30b(as shown in the cross-section ofFIGS. 2 and 7). This permits aligned sliding receipt of a distal end31of the first guidewire21into the cooperating, respective first guidewire receiving portions28a,28b, through the cooperating, respective first interface portions30a,30band into the first lumen opening22of the medical device25.

Accordingly, the present invention guidewire loader apparatus provides a simple, effective technique to load an end of a guidewire into the minute openings of a guidewire lumen of a medical device. This efficient technique enables precision loading without the need for any manual handling or the sterile devices supported on the end of a medical device, such as a crimped stent. Moreover, the present invention may be disposed or pre-loaded on an end of a suitable medical device, prior to packaging and sterilization, or the guidewire loader apparatus can be included in the packaging with the medical device prior to sterilization.

Referring now toFIG. 1, there is shown an exemplary embodiment of a guidewire loader apparatus20in accordance with the present invention. The guidewire loader apparatus20includes first and second members26a,26bconnected through a hinge member32in an opposed relationship to one another. Each first and second member26a,26bincludes a generally elongated base portion33a,33band a respective manipulating tab35a,35bextending generally outward in a direction radially away from a longitudinal axis of the respective base portion. In this configuration, manipulation of the opposed manipulating tabs35a,35b, hinged about hinge member32, enable selective clam-shell movement operation of the opposing base portions33a,33bbetween the first position (spreading the opposed base portions33a,33bapart to facilitate side loading of a medical device therein as shown inFIG. 2) and the second position (FIGS. 1 and 3), which will be described in greater detail below.

In this specific embodiment, each member26a,26bis substantially the mirror image of one another. Hence, while the guide wire receiving portion and the medical device receiving portion of the second member26bare not shown, it will be appreciated that these components are essentially an identical mirror-image of the corresponding receiving portions of the first member26a, shown inFIG. 2. Thus, turning now toFIG. 2, the respective base portion33adefines a substantially planar engaging face34a. When the base portions33a,33bare in the second position, the two substantially planar opposed engaging faces34a,34bare oriented in a substantially opposed relationship to one another (FIGS. 1).FIG. 2illustrates that engaging face34adefines a respective device receiving portion27aand a respective first guidewire receiving portion28a. These receiving portions are respectively substantially co-axially aligned with one another, and intercommunicate via the corresponding first interface portion30a. In particular, the respective first interface portion30ainterconnects an end of the respective device receiving portion27awith the corresponding distal end of the respective first guidewire receiving portion28a.

As illustrated, the device receiving portion27ais generally semi-cylindrical-shaped, and is sized to receive a number of medical devices having different diameters, such as a delivery catheter. When the loader apparatus20is oriented in the second position (FIGS. 1 and 3), two opposed medical device receiving portions27a,27bof the opposed base portions33a,33bcollectively cooperate to define a substantially cylindrical medical device receiving feature particularly suitable for receipt of a catheter device therein.

Referring now to the guidewire receiving feature of each base portion33a,33b, the respective guidewire receiving portion28ais preferably semi-conical shaped, tapering from a larger radius at a proximal end to a smaller radius at a distal end (FIG. 2). The smaller radius at a distal portion of the guidewire receiving portion28is sized to substantially match radius of the first interface portion30a. It will be appreciated, of course, that diameter or transverse cross-sectional dimension of the interface is sufficient for sliding receipt of the selected guidewire therethrough. Collectively, these two semi-conical shaped receiving portions28, in the second position, cooperate to form a conical-shaped guidewire receiving feature. Hence, the gradual taper facilitates receipt, alignment and guidance of a guidewire into a properly positioned medical device.

Referring now toFIGS. 1 and 3, the opposed manipulating tabs35a,35bare illustrated having butterfly wing-shaped gripping bodies36a,36bthat taper inwardly towards respective neck portions37a,37bthat connect to the respective base portions33a,33b. The tabs35a,35bare hingeably coupled together via a hinge member32preferably positioned at an intersection between the gripping bodies36a,36band the corresponding neck portions37a,37b. Depending upon the selected length of the neck portions37a,37b, the clamshell movement displacement between the opposed engaging faces36a,36bof the corresponding base portions33a,33b, in the first position, can be adjusted. Accordingly, the guidewire loader apparatus20is constructed as a unitary member, wherein the hinge member32couples the two members together. Additionally, it is contemplated that each the first member26aand the second member26bcould includes independent hinge member32that are coupled together to form mating units as well.

In one specific configuration, the guidewire loader apparatus20is injection molded as a single unit. Preferably, the material composition is substantially rigid, yet sufficiently resilient, at least at the hinge member32. In this configuration, the hinge members bias the first and second members26a,26btoward the second position (FIGS. 1 and 3). It is contemplated, however, that the present invention may be constructed in other manners, such as multiple components that could then be assembled to form the guidewire loader in accordance with the present invention. Examples of suitable materials include a combination of over-molded polycarbonate and polyurethane plastics. In one embodiment, the upper second member26bis composed of a clear polycarbonate to help the cardiologist thread the catheter into the stent, while the lower first member26ais composed of an over-mold combination of polycarbonate and polyurethane to keep the stent in place.

In operation, referring now toFIG. 3, there is shown the guidewire loader apparatus20is shown disposed on the distal end of a medical device25. To load the guidewire loader apparatus, a compression force is to the opposed gripping bodies36a,36bof the corresponding manipulation tabs35a,35b, causing the opposed base portions33a,33bto pivot about the hinge member32. By depressing the gripping portions closer together, the displacement between the two opposed engaging faces36a,36bcan be increased, in the first position. This spacing permits the distal end of a medical device25to be easily received and positioned within at least one of the device receiving portions27a,27b.

To accommodate side entry of the device into a mouth opening38formed between the sides of the pivoting base portions33a,33b, at least one of the base portions provides a recessed ledge portion40adjacent the respective device receiving portion27. Since these recessed ledge portions40facilitate side entry clearance, the overall pivotal displacement of the base portions33a,33bnecessary to receive the device can be reduced.

As best viewed inFIG. 2, the end of the medical device25is positioned such that the first lumen opening22into the first lumen23is oriented adjacent the first interface portion30. This is performed by placing the end of the medical device in or near abutting contact against an end shoulder41of the device receiving portion27. In this configuration, rotational alignment of the medical device about a longitudinal axis thereof, relative to the device receiving portion27is not necessary.

Once the medical device is properly positioned, the force applied to the gripping bodies36a,36bis removed, allowing the opposed base portions33a,33bto move together toward the second position (FIG. 3), via the resiliency of the hinge member32. As illustrated inFIG. 2, the medical device25is secured and supported within the respective device receiving feature collectively formed between the respective device receiving portions27a,27b.

The distal end31of the guidewire21may then be inserted into the opening of the guidewire receiving portion28, wherein the conical shape of the guidewire receiving portion urges the distal end31of the guidewire21toward and into the first interface portion30(FIG. 2). Further advancement causes the distal end31to align with the lumen opening22until the guidewire passes into the guidewire lumen23of the medical device (FIG. 3).

After the distal end of the guidewire21has been inserted into the medical device25, the guidewire loader may be removed from the end of the medical device25by applying a similar inward force to the opposed manipulating tab gripping bodies36a,36b. Consequently, the base portions33a,33bare spread apart in the clam-shell movement by an amount sufficient to release the medical device25with the loaded guidewire. This is particularly useful since side removal between the clam-shell movements of the base portions need not require stringing the loader all the way down the guidewire21to a proximal end thereof.

Referring now toFIGS. 4-9, an alternative embodiment of the guidewire loader apparatus20is provided that is capable of loading medical devices supporting two guidewires, such as bifurcation stent delivery catheters. In these dual guidewire medical devices, a second guidewire lumen42is disposed adjacent the first guidewire lumen23. Generally, however, a second lumen opening43into the second guidewire lumen42may be positioned proximal to the first lumen opening.

Accordingly, in this dual configuration, the respective engaging faces36a,36bof the corresponding base portions33a,33bwill further define a respective second guidewire receiving portion45a(FIG. 7) and 45b(FIG. 8) that terminates at the respective medical device receiving portions27a,27bat respective second interface portions46a,46b. The longitudinal position and placement of the respective second interface portions46a,46b, thus, must suitably match the longitudinal position of the second lumen opening43of the medical device25.

Referring now toFIGS. 5 and 7, the respective second guidewire receiving portions45a,45bare preferably semi-conical shaped, similar to the respective first guidewire receiving portions28a,28b. Hence, the cooperating second guide receiving portions taper inwardly from a larger radius at a proximal end to a smaller radius at a distal end thereof. Again, the smaller radius is sized to substantially match radius of the second interface portion46a,46b.

In one specific embodiment, while the respective first and second guidewire receiving portions28a,28xb, and45a,45b, the respective first and second interface portions30a,30b, and46a,46b, and the respective device receiving portions27a,27b, collectively form the two guidewire receiving features and the medical device receiving feature, they need not be identical mirror images of one another. In fact, due to the nature an alignment structure, to be henceforth, one base portion33may define a more significant section of the collective receiving feature than that of the other base portion (FIGS. 7 and 8).

In accordance with the present invention, alignment structure may be incorporated to facilitate precision alignment between the opposed, respective medical device receiving portions27a,27b, the first and second guidewire receiving portions28a,28band45a,45b, and the interface portions30a,30band46a,46bwhen the first and second members26a,26bare oriented in the second position (FIGS. 4 and 6). The alignment structure may include an alignment lip47upstanding from one of the engaging faces (e.g., face34aof the first member26a). Further, the other engaging face (e.g., face34bof the second member26b) may define a corresponding alignment recess48downstanding therefrom that is aligned and sized for receipt of the upstanding alignment lip47, when the opposed engaging faces36a,36b, and thus the first member and second member, are oriented in the second position. These mating alignment components facilitate precision alignment between the opposed respective medical device receiving portions, the guidewire receiving portions and the interface portions, in the second position.

More preferably, as best viewed inFIGS. 5 and 7, the upstanding alignment lip47peripherally surrounds at least a portion of one of the respective medical device receiving portion27a, the first and second guidewire receiving portion28a,45aand/or the first and second interface portions30a,46a. Similarly, the corresponding alignment recess48(FIGS. 8 and 9), in this configuration, also peripherally surrounds the other of the at least a portion of the respective medical device receiving portion27b, the first and second guidewire receiving portion28b,45band/or the first and second interface portions30b,46b. It will be appreciated of course that while the first member26ais shown and described as defining the upstanding alignment lip47, it could have just as easily defined the downstanding alignment recess48as well, or a combination thereof, without departing from the true spirit and nature of the present invention.

To further align and retain the opposed base portions33a,33bof the corresponding first and second members26a,26bsecurely to one another, in the second position, an analogous manipulating tab35bmay be provided in the form of a pair of opposed clip members50′,50″ (FIG. 9). In one specific embodiment, these opposed clip members50′,50″ are hingeably mounted (at hinged sections51′,51″ that flank the clip members) to the respective base portion (e.g., base portion33binFIGS. 8 and 9) on opposed sides of a longitudinal axis of the respective medical device receiving portion27b. Again it will be appreciated that the clip members50′,50′ can also be easily provided by the first member26aas well.

One end of each clip member50′,50″ contains a respective grip portion52′,52″ (FIGS. 4,6and9), while an opposite end thereof contains a clip portion53′,53″ configured to releasably grip and engage a corresponding clip region55′,55″ of the opposed base portion33aof the first member26awhen the loader apparatus is in the second position. Preferably, grip portions52′,52″ (FIG. 4) are generally parallel to the longitudinal axis of the medical device receiving portion27a. More preferably, each clip portion53′,53″ includes a respective ting56′,56″ (FIGS. 5 and 9), while the corresponding clip region55′,55″ is provided by a shoulder portion57′,57″ (FIG. 5) that cooperate with the corresponding tings to retain the first and second members in the second position. The opposed clip portions53′,53″ (e.g., tings) of the second member26b are sized, dimensioned and spaced to engage the corresponding clip regions55′,55″ (e.g., shoulder portions) of the first member26a. Each clip region55′,55″ includes spaced-apart clip slots58′,58″ sized and dimensioned for receipt of the corresponding clip portions53′,53″ during assembly from the first position to the second position.

Referring now toFIGS. 4,5and7, the first member26aalso includes an analogous manipulating tab35athat extends proximally from the respective base portion33a, in a direction generally along the longitudinal axis of the respective medical device receiving portion27. The tab35includes an upward facing surface60containing a plurality of laterally extending gripping ribs61. The ribs61and the manipulating tab35enables gripping of the first member26a, and is particularly functional when loading the medical device25in the corresponding device receiving portion27a. In fact, a portion of the respective medical device receiving portion27aextends continuously along the upward facing surface60of the manipulating tab35a.

Accordingly, in the first position (FIGS. 5 and 7), the dual guidewire lumen medical device25may be loaded onto the first member26a. Initially, the medical device25is aligned with and placed into the respective device receiving portion27aof the corresponding base portion33of the first member26a. As shown inFIG. 7, the distal tip of the medical device is placed proximate to the first interface portion30a, orienting the first lumen opening22adjacent the same. Further, the medical device25is rotated about its longitudinal axis in an effort to align the second interface portion46aadjacent to the second first lumen opening22of the medical device. Once properly oriented and positioned, the user may grip the manipulating tab35aand a portion of the loaded medical device25together, sandwiching and securing the medical device25between their thumb or finger and the upward facing surface60just prior to assembly of the first and second members26a,26b.

The second member26bis then aligned with the first member26a, as shown in (FIG. 5), by initially placing the opposed engaging faces toward one another. To assemble the first and second members, the clip portions53′,53″ of the clip members50′,50″ are align with the clip slots58′,58″ of the second member base portion33b. As the opposed base portions33a,33bare forced together, a backside ramp surface of the corresponding clip portion53′,53″ slideably engages and contacts a corresponding sidewall62′,62″ defining the clip slots58′,58″, causing resilient movement of the clip members50′,50″ about the corresponding hinged sections51′,51″. Once the corresponding tings56′,56″ move beyond an edge of the shoulder portions57′,57″ of the clip region55′,55″, the first and second members26a,26bare releasably retained together, as well as securing the medical device25in the second position (FIGS. 4 and 6).

FIG. 7best illustrates that once the medical device25is properly positioned, a distal end of a guidewire (e.g., guidewire21) may be inserted into either opening of the first guidewire receiving portion28aor the second guidewire receiving portion45a. The respective conical shape of either guidewire receiving portion urges the distal end of the guidewire21toward and into the first interface portion30or the second communication portion, respectively. Further advancement causes the distal end to align with the first lumen opening22or second lumen opening of the medical device until the guidewire passes into the first guidewire lumen23of the second guidewire lumen thereof.

After insertion of one or both guidewires into the respective lumens of the medical device25, the guidewire loader apparatus may be removed from the end of the medical device25. By applying an inward force to the opposed grip portions52′,52″ of the clip members50′,50″, the corresponding clip portions53′,53″ are spread apart in the clam-shell movement about the corresponding hinge sections51′,51″ at the base portion33b. Once the corresponding tings56′,56″ move beyond the corresponding shoulder portions57′57″, the first member26aand the second member26bare released from one another. Again, this design is particularly useful since removal of the members need not require stringing the loader all the way down the guidewire21to a proximal end thereof.

In an alternative embodiment (not shown), in an effort to align the second lumen opening43of the medical device with the second interface portion46aand the second guidewire receiving portion45a, an alignment tube may be added having a lumen suitably sized for sliding receipt of the second guidewire, yet having an outer diameter sized for receipt in the second lumen opening43of the medical device25, as well as receipt in the second guidewire receiving portion45.

In accordance with this alternative embodiment, a distal end of an alignment tube may be slideably pre-installed into the second lumen opening43of the medical device. During loading of the medical device25into the device receiving portion27a, the alignment tube can be aligned with and placed into the second guidewire receiving portion45. Once the first and second members are assembled, in the second position, the lumen of the alignment tube can be employed to facilitate insertion of the guidewire into the second guidewire lumen of the medical device. Subsequently, the alignment tube may be removed along with the loader apparatus.

Such a technique may be particularly useful for loading the second guidewire in bifurcation stent crimped onto a delivery catheter. In some designs, the guidewire is directed through the scaffolding of the crimped stent, and into the second lumen opening43of the medical device25. During positioning on the loader, the crimped stent may move or be repositioned, blocking or impeding access to the second lumen opening.

Further still, it is contemplated that the guidewire loader in accordance with the present invention may be packaged together with a suitable medical device, such as that shown in U.S. Pat. No. 6,136,010, the entirety of which is hereby incorporated by reference. The guidewire loader may be disposed on the distal end of the medical device prior to packaging and sterilization, or the guidewire loader can be included in the packaging with the medical device prior to sterilization.

While the preferred embodiment of the invention has been illustrated and described, it will be appreciated that various changes can be made therein without departing from the scope of the invention. For example, a guidewire loading tool could have a conventional handle or a handle with a differently shaped ergonomic grip. It is therefore intended that the scope of the invention be determined from the following claims and equivalents thereof.