# Patent

## Title
Access device

## Abstract

An access device places a medical article within a body space of a patient. The device has a needle section that includes an elongated body and a needle hub. The device further includes a dilator portion that has a dilator and a dilator hub. The dilator is coaxially disposed and slideable over the elongated body of the needle section. The device further includes a sheath section that has a sheath and a sheath hub. The sheath is coaxially disposed and slideable over the dilator. The device further includes a first locking mechanism operably disposed between the needle hub and the dilator hub to inhibit at least unintentional axial movement between the needle section and the dilator portion and a second locking mechanism operably disposed between the dilator hub and the sheath hub to inhibit at least unintentional axial movement between the dilator portion and the sheath section.

## Background
RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 13/084,440, filed on Apr. 11, 2011, now issued as U.S. Pat. No. 7,922,696, which is a continuation of U.S. patent application Ser. No. 12/019,598, filed on Jan. 24, 2008 and entitled “ACCESS DEVICE,” now issued as U.S. Pat. No. 8,377,006, which claims the benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 60/886,443, filed Jan. 24, 2007, the entire contents of each hereby incorporated by reference.


BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is generally directed to access devices for introducing and delivering a catheter cannula or sheath into an artery, vein, vessel, body cavity, or drainage site.
2. Description of the Related Art
A preferred non-surgical method for inserting a catheter or vascular sheath into a blood vessel involves the use of the Seldinger technique, which includes an access needle that is inserted into a patient's blood vessel. A guidewire is inserted through the needle and into the vessel. The needle is removed, and a dilator and sheath combination are then inserted over the guidewire. The dilator and sheath combination is then inserted a short distance through the tissue into the vessel, after which the dilator and guidewire are removed and discarded. The catheter may then be inserted through the sheath into the vessel to a desired location.
A number of vascular access devices are known. U.S. Pat. Nos. 4,241,019, 4,289,450, 4,756,230, 4,978,334, 5,124,544, 5,424,410, 5,312,355, 5,212,052, 5,558,132, 5,885,217, 6,120,460, 6,179,823, and 6,210,332 disclose examples of such devices. None of these devices, however, has the ease and safety of use that physicians and other healthcare providers would prefer and, thus, there is a need for an easier-to-use and safer vascular access device, especially one that would clearly indicate when a blood vessel has been punctured.
SUMMARY OF THE INVENTION
The present invention involves several features for an access device useful for the delivery of a catheter or sheath into a space within a patient's body, such as, for example, a blood vessel or drainage site. Without limiting the scope of this invention, its more prominent features will be discussed briefly. After considering this discussion, and particularly after reading the Detailed Description of the Preferred Embodiments section below in combination with this section, one will understand how the features and aspects of this invention provide several advantages over prior access devices.
One aspect of the present invention is an access device for placing a medical article within a body space. The device has a needle section that includes an elongated body and a needle hub. The elongated body has distal and proximal ends. The distal end is configured for insertion into a patient's body. The proximal end is coupled with the needle hub. The device further includes a dilator portion including a dilator and a dilator hub. The dilator is coaxially disposed and slideable over the elongated body of the needle section with the dilator hub being disposed distal of the needle hub. The device further includes a sheath section that has a sheath and a sheath hub. The sheath is coaxially disposed and slideable over the dilator with the sheath hub being disposed distal of the dilator hub. The device further includes a first locking mechanism operably disposed between the needle hub and the dilator hub to inhibit at least unintentional axial movement between the needle section and the dilator portion when the first locking mechanism is engaged and a second locking mechanism operably disposed between the dilator hub and the sheath hub to inhibit at least unintentional axial movement between the dilator portion and the sheath section when the second locking mechanism is engaged. Each of said first and second locking mechanisms is configured to be engaged by moving the respective hubs in a non-axial manner relative to each other. The first locking mechanism is configured to move in a manner different from the manner in which the second locking mechanism is engaged.
Another aspect of the invention is an access device for placing a medical article within a body space. The device includes a needle section including an elongated needle body with a sharp distal tip and a needle hub from which the needle body extends. The device further includes a dilator portion that includes a dilator and a dilator hub. The dilator is coaxially disposed and slideable over the needle body with the dilator hub being disposed distal of the needle hub. The device further includes a sheath section that includes a sheath and a sheath hub. The sheath is coaxially disposed and slideable over the dilator with the sheath hub being disposed distal of the dilator hub. The device further includes a locking mechanism disposed within the dilator and selectively operating between the needle body and the dilator. The locking mechanism is configured to arrest axial movement of the needle body at least in the distal direction once the distal tip of the needle body is drawn into the dilator portion to sheath the distal tip.
Yet another aspect of the invention is an access device for placing a medical article within a body space. The device includes a dilator hub that has a passageway configured to receive an elongated needle. The needle has at least one side receptacle. The device further includes one or more fingers or tangs disposed in the dilator hub and configured to engage with the at least one side receptacle at least when the needle is retracted through the passageway.
Additionally, a releasable interlock can be provided in some embodiments to inhibit relative rotational movement between the needle section and the dilator section, at least when the needle is inserted into a patient. By inhibiting such relative rotational movement, communicating side openings in the needle and the dilator can be held in alignment to provide a simplified passageway through which the blood or fluid may flow. Thus, when the needle enters a blood vessel or drainage site in the patient, blood or other body fluid quickly flows into the passageway. The resulting blood or fluid flash is visible through the sheath section (or catheter) to indicate that the needle tip has entered the vessel or drainage site.
For example, but without limitation, the dilator portion or section can comprise, in some embodiments, a dilator hub and dilator having one or more side openings. The dilator hub may have a luer connection and a releasable locking mechanism. The releasable locking mechanism can be configured to releasably engage and secure the dilator section to another part, such as the needle hub. When the needle hub and the dilator hub are releasably locked to prevent rotation therebetween, one or more of the side openings in the dilator are aligned with one or more side openings in the needle. The locking mechanism can also be configured to inhibit unintentional relative axial movement between the needle and the dilator.
The sheath section preferably, but not necessarily, includes a sheath and sheath hub. The sheath may be made partially or completely from a clear, translucent, semi-opaque, or transparent material. Such transparent, translucent, semi-opaque and clear materials allow a clinician the ability to see when blood or other body fluids flows into the needle, through the needle side opening(s), through the side dilator opening(s), and into the viewing space between the dilator and sheath.
These and other aspects of the present invention will become readily apparent to those skilled in the art from the following detailed description of the preferred embodiments, which refers to the attached figures. The invention is not limited, however, to the particular embodiments that are disclosed.



BRIEF DESCRIPTION OF THE DRAWINGS
These and other features, aspects, and advantages of the invention disclosed herein are described below with reference to the drawings of preferred embodiments, which are intended to illustrate and not to limit the invention.
FIG. 1A is a perspective view of a preferred embodiment of an access device configured in accordance with the present invention.
FIG. 1B is an enlarged plan view of a needle hub, a dilator hub, and a sheath hub of the access device illustrated in FIG. 1A, shown in an assembled state.
FIG. 1C is a perspective view of the assembly of the needle hub, dilator hub and sheath hub illustrated in FIG. 1B.
FIG. 2A is side view of a needle section of the embodiment depicted in FIG. 1A.
FIG. 2B is a cross-sectional view of the needle section of the embodiment depicted in FIG. 2A taken along line A-A.
FIG. 2C is an enlarged plan view of the needle hub of the needle section of FIG. 2B.
FIG. 3A is a side view of the dilator portion of the embodiment depicted in FIG. 1A.
FIG. 3B is a proximal end view of the dilator portion of FIG. 3A.
FIG. 3C is a cross-sectional view of the dilator portion of the embodiment depicted in FIG. 3A, taken along line B-B.
FIG. 3D is an enlarged perspective view of the dilator hub of the dilator portion of FIG. 3A.
FIG. 4A is a side view of a sheath section of the embodiment from FIG. 1A.
FIG. 4B is a proximal end view of the sheath section of FIG. 4A.
FIG. 4C is an enlarged perspective view of the sheath hub of the sheath section of FIG. 4A.
FIG. 5 is a side view of the access device of FIG. 1A.
FIG. 6 is an enlarged cross-sectional view of a portion of the embodiment illustrated in FIG. 5 which is circled by line C-C.
FIG. 7A is a schematic, enlarged cross-sectional view of a portion of the needle within the dilator and illustrates an embodiment of a locking mechanism configured in accordance with one aspect of the present invention.
FIGS. 7B-7D illustrate the operational steps of the locking mechanism of FIG. 7A when arresting relative axial movement between the needle and the dilator.
FIG. 8A is a similar cross-sectional view of a portion of a locking mechanism which is configured in accordance with another preferred embodiment of present invention. FIG. 8A illustrates the locking mechanism in an unlocked state.
FIG. 8B illustrates the locking mechanism of FIG. 8A in a locked state.
FIG. 9A is a schematic, enlarged cross-sectional view of a locking mechanism configured in accordance with an additional embodiment of the present invention. FIG. 9A illustrates the locking mechanism in an unlocked state.
FIG. 9B illustrates the locking mechanism of FIG. 9A in a locked state.
FIG. 10A is a schematic, enlarged cross-sectional view of a locking mechanism configured in accordance with a further embodiment of the present invention. FIG. 10A illustrates the locking mechanism in an unlocked state.
FIG. 10B is a cross-sectional view of the locking mechanism of FIG. 10A taken along lines 10B-10B.
FIG. 11 is an enlarged exploded view of a dilator hub and locking plate assembly configured in accordance with an additional preferred embodiment of the present invention.
FIG. 12A is an enlarged view of an embodiment of the locking plate that can be used with the dilator hub shown in FIG. 11.
FIG. 12B is an enlarged view of another embodiment of the locking plate that can be used with the dilator hub shown in FIG. 11.
FIG. 12C is an enlarged view of an additional embodiment of the locking plate that can be used with the dilator hub shown in FIG. 11.
FIGS. 13A-13D are enlarged views of perimeter shapes that the locking plate can have in accordance with additional embodiments of the present invention.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present disclosure provides an access device for the delivery of a catheter or sheath to a blood vessel or drainage site. FIG. 1 illustrates an access device 102 that is configured to be inserted into a blood vessel in accordance with a preferred embodiment of the present invention. While the access device is described below in this context (i.e., for vascular access), the access device also can be used to access and place a catheter or sheath into other locations within a patient's body (e.g., for draining an abscess) and for other purposes.
FIG. 1A is a perspective view of a preferred embodiment of an access device 102. The access device 102 comprises a needle section 20, a dilator portion 28, a sheath section (e.g., catheter or cannula) 58, and a guidewire 120. In preferred embodiments, the dilator portion 28 is coaxially mounted on the needle section 20, and the sheath section 58 is coaxially mounted on the dilator portion 28. The needle section 20 comprises a needle 22 and a needle hub 21. The needle hub 21 is disposed on a proximal end of the needle 22. The dilator portion 28 comprises a dilator 30 and a dilator hub 32. The dilator hub 32 is disposed on the proximal end of the dilator 30. The sheath section 58 comprises a sheath 54 and a sheath hub 53. The sheath hub 53 is disposed on the proximal end of the sheath 54.
FIG. 1B is an enlarged plan view of the needle hub 21, the dilator hub 32, and the sheath hub 53 of the access device illustrated in FIG. 1A, shown in an assembled state. The needle hub 21, the dilator hub 32, and the sheath hub 53 include structures that releasably interlock the hubs so as to provide a structural and fluid connection between the needle section 20, the dilator portion 28, and the sheath section 58.
FIG. 1C is a perspective view of the assembly of the needle hub 21, dilator hub 32 and sheath hub 53 illustrated in FIG. 1B. With reference to FIGS. 1A and 1B, the needle section 20, dilator portion 28, and sheath section 58 are interlocked at the proximal end 110 of the access device 102. In some embodiments, the releasable interlock between the needle section 20, dilator portion 28, and sheath section 58 is a tandem interlock where the dilator portion 28 is locked to the needle section 20 at interface 101 and the sheath section 58 is locked to the dilator portion 28 at interface 103. In additional to a structural connection, the interlocks provide a fluidic connection through the access device 102.
Preferably, the needle section 20 locks to the dilator portion 28 via a lock mechanism 26. The lock mechanism 26 may comprise an engaging mechanism such as hinged clips 27 with actuator sides 29. The hinged clips 27 may releasably engage and secure to corresponding catches 25 on the dilator portion 28. In some embodiments, the clip sides 29 engage and secure the dilator portion 28 by clipping to the outer lip of a luer connection 33 on the dilator portion 28. Although hinged clips 27 are shown, the lock member 26 may comprise any suitable engaging mechanism known in the art. In the illustrated embodiment, as best seen in FIG. 3B, the portions of the outer lip onto which the hinge clips 27 engage are flats to inhibit rotation of the needle hub 21 relative to the dilator hub 32 after a certain degree of relative rotation (e.g., 180 degrees) between the needle hub 21 and the dilator hub 32.
Similarly, the sheath section 58 is secured to the dilator portion 28 through a lock member 59. The sheath section 58 may, preferably, comprise a twist lock member 59 so that the user may releasably engage and secure the dilator portion 28 to the sheath section 58. In some preferred embodiments, the dilator portion 28 comprises teeth or prongs that are configured to mate or attach to corresponding areas on the sheath section 58. Preferably, the needle 20, dilator 28 and sheath 58 are releasably locked so that a physician or user may remove sections or portions of the access device as needed for treatment.
FIG. 2A is side view of the needle section 20 of the embodiment depicted in FIG. 1A. FIG. 2B is a cross-sectional view of the needle section 20 depicted in FIG. 2A taken along line A-A. As shown in both FIGS. 2A and 2B, the needle section 20 has a needle 22, distal portion 106, and proximal portion 24. Preferably, the proximal portion 24 has the needle hub 21 and the lock member 26. In addition, the needle 22 may have a bevel tip 108 disposed on the distal portion 106. The needle 22 may further comprise one or more side openings 34.
FIG. 2C is an enlarged plan view of the needle hub 21 of the needle section 20 of FIG. 2B. As most clearly shown in FIG. 2C, the needle hub 21 may also have a luer connection 35 at the proximal portion 24 of the needle 20. This allows the physician or healthcare provider, for example, to introduce a guidewire 120 through the hollow portion of the luer connection 35, through the needle 22, and into a punctured vessel. Additionally, a physician or healthcare provider may also attach a syringe to the luer connection 35 to perform other procedures as desired.
As discussed above, in preferred embodiments, the needle hub 21 comprises the lock member 26. The lock member 26 may be configured to lock or secure another part such as, for example, the dilator portion 28 or the sheath section 58, to the needle section 20. As shown most clearly in FIG. 2C, the lock member 26 can comprise an engaging mechanism such as a pair of hinged clips 27, although other types of locking mechanisms comprising tabs and/or slots can also be used. Preferably, the clip sides 29 of the hinged clips 27 can engage a lipped surface such as the outer lip of a luer connection 33, shown in FIG. 1A. Once engaged, the clip sides 29 prevent the locked part from undesired slipping or releasing. In certain embodiments, the clips 27 are hinged to provide a bias towards the center of the needle hub 21. Preferably, the bias prevents the secured part from slipping or disengaging from the hinged clips 27. More preferably, the bias of the hinged clips 27 can be overcome by simultaneously applying pressure on the sides 29 of the clips 27 to release, for example, the luer connection 33 from the needle hub 21. To apply the appropriate releasing pressure, a physician or healthcare provider may, for example, place an index finger and thumb on the sides 29 of the hinged clips 27 and apply squeezing pressure to overcome the hinge bias. The hinged clips 27 will, preferably, release only when sufficient releasing pressure is applied to both clip sides 29.
As shown most clearly in FIG. 2A, the needle proximal portion 24 may have color coding, words, or other indicia, such as a pivot or notch, to indicate to the operator the position of the bevel tip 108 relative to the dilator 28 or the sheath section 58. For example, the arrow embedded into the needle hub 21 indicates the bevel up position of the needle 22 and may further indicate to the healthcare provider the proper way to use the device. Also, there may be a mechanical fit between the dilator 28 and the needle 22 so that the physician or healthcare provider would sense by feel or sound (e.g., by a click) when the needle 22 has been rotated to change the position of the bevel tip 108.
FIG. 3A is a side view of the dilator portion 28 of the embodiment depicted in FIG. 1A. FIG. 3B is a proximal end view of the dilator portion 28 of FIG. 3A. FIG. 3C is a cross-sectional view of the dilator portion 28 of the embodiment depicted in FIG. 3A, taken along line B-B. As shown, the dilator portion 28 may comprise the dilator 30 and the dilator hub 32. The dilator 30 may further comprise one or more side openings 111. The dilator hub 32 preferably comprises a luer connection 33 with an outer lip 37. In some embodiments, the outer lip 37 can be configured to engage to the lock member 26 on the needle section 20 illustrated in FIG. 2C.
Additionally, the dilator 30 may be coaxially mounted to the needle 22 by slipping a hollow section 113 of the dilator 30 over the needle 22 and releasably securing the dilator hub 32 to the needle hub 21. Preferably, the proximal end 45 of the dilator hub 32 is configured to mechanically fit and interlock with the needle lock member 26 to inhibit at least some rotational and axial motion. More preferably, the dilator 30 is releasably mounted to the needle 22 so that the dilator 30 can be mounted and released, or vice versa, from a coaxial position relative to the needle 22.
FIG. 3D is an enlarged perspective view of the dilator hub 32 of the dilator portion 28 of FIG. 3A. As is most clearly illustrated in FIG. 3D, the dilator hub 32 may further comprise a locking mechanism 39. The locking mechanism 39 comprises one or more posts, teeth, or prongs projecting from the dilator hub 32. The locking mechanism 39, which may be in the form of teeth, can be configured to mate or attach to corresponding receiving areas disposed on another part such as the sheath section 58 or the needle hub 21. This locking mechanism 39 will be explained in greater detail in the following section.
FIG. 4A is a side view of the sheath section 58 of the embodiment from FIG. 1A. FIG. 4B is a proximal end view of the sheath section 58 of FIG. 4A. In preferred embodiments, the sheath section 58 comprises a sheath 54 and a sheath hub 53. The sheath 54 may also be made partially or completely from clear, translucent, transparent, or semi-opaque material. The sheath hub 53 may further comprise winged ends 55 and a lock member 59.
FIG. 4C is an enlarged perspective view of the sheath hub 53 of the sheath section 58 of FIG. 4A. Preferably, the locking member 59 may comprise a locking or attaching structure that mates or engages with a corresponding structure. As most clearly shown in FIGS. 4B and 4C, the locking member 59 may comprise indentations, bumps, or grooves designed to engage and secure the locking mechanism or teeth 39 on the dilator hub 32 described above with reference to FIG. 3D.
The sheath hub 53, as best seen in FIGS. 4B and 4C, preferably is designed so that the locking mechanism or teeth 39 of the dilator hub 32 can enter the sheath hub 53 substantially unobstructed. However, in use, once the sheath hub 53 is placed at a desired location over the dilator 30, the physician or healthcare provider can twist the sheath hub 53 and disengage or engage the locking member 59. The locking member 59 can be, for example, a protruding bump, dent, etc., that creates a mechanical fit so that the dilator hub 32 and the sheath hub 53 are releasably interlocked. In the illustrated embodiment, the locking member 59 of the sheath hub 53 comprises a pair of axial arranged grooves which extend from a distal side of the sheath hub 53 and terminate at a protruding bump, dent, etc. Preferably, the locked position can be disengaged by twisting the dilator hub 32 relative to the sheath hub 53. Additionally, the sheath hub may comprise wings 55 or handle structures to allow for easy release and removal of the sheath 54 from other parts of the access device 102.
In some applications, the wings 55 are sized to provide the healthcare provider with leverage for breaking apart the sheath hub 53. For example, the sheath hub 53 may comprise a thin membrane 61 connecting the halves of the sheath hub 53. The membrane 61 is sized to keep the halves of the sheath hub 53 together until the healthcare provider decides to remove the sheath hub 53 from the access device. The healthcare provider manipulates the wings 55 to break the membrane 61 and separate the sheath hub 53 into removable halves.
FIG. 5 is a side view of the access device of FIG. 1A in which the needle section 20, dilator portion 28, and sheath section 58 are interlocked together. In the assembly, as noted above the needle section 20, dilator portion 28 and sheath section 58 are coaxially disposed about a common longitudinal axis and form a central fluid connection.
FIG. 6 is an enlarged cross-sectional view of a portion of the embodiment illustrated in FIG. 5 which is circled by line C-C. As noted above, the needle 22, preferably, comprises one or more side openings 34 in its side wall. Additionally, the dilator may comprise one or more side openings 111. FIG. 6, however, illustrates the alignment between only one set of corresponding side openings. Other sets of side openings can also be aligned or be misaligned depending upon the relative orientations of the needle and the dilator.
Preferably the dilator 30 may be coaxially positioned to minimize the annular space 36 between the needle 22 and the dilator 30. The inner surface 38 of the dilator 30 need not, though it can, lie directly against the outer-surface 40 of the needle 22. Preferably, the annular interface 36 between the outer-surface 40 of the needle 22 and the inner surface 38 of the dilator 30 is minimized to inhibit the flow of blood or its constituents (or other bodily fluids) into the annular interface 36 between the dilator 30 and needle 22. Advantageously, this feature minimizes the blood's exposure to multiple external surfaces and reduces the risk of contamination, infection, and clotting.
The sheath 54 is made partially or completely from clear, semi-opaque, translucent, or transparent material so that when blood flows into the needle 22, (1) through the needle side opening 34, (2) through the dilator side opening 111, and (3) into an annular space 60 between the dilator 30 and the sheath 54, the physician or healthcare provider can see the blood. This will indicate to the physician or healthcare provider that the bevel tip 108 of the needle 22 has punctured a blood vessel.
More preferably, the dilator 30 can be coaxially mounted to the needle 22 such that at least one side opening 34 disposed on the needle 22 is rotationally aligned with at least one side opening 111 on the dilator 30. In some embodiments, the needle 22 and dilator 30 may (both) have multiple side openings 34, 111 where some or all of these side openings 34, 111 can be rotationally aligned. Preferably, the needle 22 and dilator 30 maintain rotational alignment so that blood flows substantially unobstructed through the needle side opening 34 and dilator side opening 111.
While the side openings 34, 111 in the needle 22 and the dilator 30 are aligned in the embodiment illustrated in FIG. 6, the side openings alternatively can overlap with each other or can be connected via a conduit. The conduit can be formed between the side openings 111, 34 in the dilator and the needle.
In accordance with another aspect of the present invention, there is provided an interlock or interconnection between the needle 22 and at least one of the dilator 30 or dilator hub 32. The interlock or interconnection inhibits the bevel tip 108 disposed on the distal portion 106 of the needle 22 from being advanced beyond the distal end of the dilator 30 once the dilator 30 has been advanced over the needle 22 during use. The dilator 30 thus sheaths the sharp bevel tip 108 of the needle 22 to inhibit accidental needle sticks from occurring.
FIG. 7A is a schematic, enlarged cross-sectional view of a portion of the needle 22 within the dilator 30 and illustrates an embodiment of a locking mechanism 115 configured in accordance with one aspect of the present invention. When engaged, the locking mechanism 115 inhibits movement of the needle 22 with respect to the dilator 30 in at least one direction. For example, the locking mechanism 115 can inhibit movement of the needle 22 at least in the distal direction once the distal tip of the needle body is drawn into the dilator portion to sheath the distal tip. The embodiment of the locking mechanism 115 illustrated in FIG. 7A comprises one or more arms or tangs 117, 119, one or more bases 121, 123, and one or more pivot couplings or hinges 127, 129.
The arm 117 may be axially aligned with the arm 119. Alternatively, the arms 117, 119 may be offset from each other in a radial direction. The arms 117, 119 may be slightly rotated relative to each other or disposed at different radial locations on the inside surface of the dilator 30. The tang or arm 117, 119 may move in a direction generally transverse to a longitudinal axis of the needle body when engaging the receptacle or hole 131.
The locking mechanism 115 is illustrated on the dilator 30. However, the needle 22 may instead comprise the locking mechanism 115. In the illustrated embodiment, the needle 22 comprises a receptacle, recess, opening, or hole 131 which interacts with the locking mechanism 115 of the dilator 30 when the needle 22 is sufficiently retracted into the dilator 30. The receptacle, recess, opening, or hole 131 may extend entirely around the needle 22 forming an annular groove or around only a portion of the needle 22.
For embodiments that have arms 117, 119 disposed at different radial locations on the inside surface of the dilator 30, the needle 22 may comprise more than one recess, opening, or hole 131. The multiple recesses, openings, or holes 131 are disposed at radial locations around the outer surface of the needle 22 that correspond to the radial spacing of the arms 117, 119 around the inside surface of the dilator 30.
The arm 117 is coupled to the base 121 via hinge 127 and rotates from an unlocked position to a locked position in a counter-clockwise direction. The arm 119 is coupled to the base 123 via hinge 129 and rotates from an unlocked position to a locked position in a clockwise direction. In the illustrated embodiment, each arm 117, 119 rotates approximately 90 degrees between the unlocked position and the locked position. However, the locked position may be more or less than 90 degrees from the unlocked position. The arms 117, 119 need only rotate a sufficient amount to allow their distal ends to abut against a portion of the perimeter of the recess, opening, or hole 131.
The recess, opening, or hole 131 in the needle 22 locally increases a gap located between an outside surface of the needle 22 and an inside surface of the dilator 30 a sufficient amount to allow the arms 117, 119 to rotate about their respective hinges 121, 123 and towards the locked position. When the arm 117 is in the locked position, the needle 22 is inhibited from relative axial movement with respect to the dilator 30 in a proximal direction. When the arm 119 is in the locked position, the needle 22 is inhibited from relative axial movement with respect to the dilator 30 in a distal direction.
The one or more bases 121, 123 are attached to or integral with the dilator 30 and extend generally towards the coaxially aligned needle 22. The bases 121, 123 are sized so as to not interfere with movement of the needle 22 through the dilator 30 while providing hinge points for attachment of the arms 117, 119. The arms 117, 119 are sized to allow movement of the needle 22 through the dilator 30 when the arms 117, 119 are in the unlocked position. The hinges 127, 129 permit the arms 117, 119 to move from the unlocked position illustrated in FIG. 7A to a locked position illustrated in FIG. 7D.
Each arm 117, 119 can separately move to the locked position when the arm 117, 119 is axially aligned with the recess, opening, or hole 131 in the needle 22. Once in the locked position, the hinge 127, 129 does not permit the arm 117, 119 to move back to the unlocked position. In some embodiments, the hinges 127, 129 slightly bias the arms 117, 119 to move towards the locked position. For example, the tang or arm 117, 119 can be biased toward the receptacle, recess, opening, or hole 131.
FIGS. 7B-7D illustrate the operational steps of the locking mechanism 115 of FIG. 7A when arresting relative axial movement between the needle 22 and the dilator 30. FIG. 7B illustrates the arms 117, 119 in the unlocked position. In the unlocked position, the recess, opening, or hole 131 in the needle 22 is not axial aligned with the arms 117, 119 of the locking mechanism 115. A healthcare provider can move the needle 22 with respect to the dilator 30 in both proximal and distal directions as long as the recess, opening, or hole 131 in the needle 22 stays on the proximal side of the locking mechanism 115 as is illustrated in FIG. 7B.
FIG. 7C illustrates the arm 117 in the locked position. In the locked position, the distal end of the arm 117 is disposed within the recess, opening, or hole 131 in the needle 22. Once in the locked position, the hinge 127 does not permit the arm 117 to rotate back to the unlocked position. When the arm 117 is in the locked position, the needle 22 may still move in a distal direction with respect to the dilator 32 until the recess, opening, or hole 131 is aligned with the arm 119.
FIG. 7D illustrates both arms 117, 119 in the locked position. In the dual locked position, the distal ends of the arms 117, 119 are disposed within the recess, opening, or hole 131 in the needle 22. Once in the dual locked position, the hinges 127, 129 do not permit the arms 117, 119 to rotate back to the unlocked position. When the arm 119 is in the locked position, the needle 22 is inhibited from moving in the distal direction with respect to the dilator 32.
FIG. 8A is a similar cross-sectional view of a portion of a locking mechanism 137 which is configured in accordance with another preferred embodiment of present invention. When engaged, the locking mechanism 137 inhibits movement of the needle 22 with respect to the dilator 30 in both directions. The embodiment of the locking mechanism 137 illustrated in FIG. 8A comprises one or more pairs of v-shaped arms 135, 137. The pairs of arms 135, 137 are disposed on diametrically opposite sides of the needle 22. Alternatively, the arms 135, 137 may be offset from each other in a radial direction more or less than 180 degrees apart.
The locking mechanism 133 is illustrated on the dilator 30. However, the needle 22 may instead comprise the locking mechanism 133. In the illustrated embodiment, the needle 22 comprises a recess, opening, or hole 139 which interacts with the locking mechanism 133 of the dilator 30 when the needle 22 is sufficiently retracted into the dilator 30. The receptacle, recess, opening, or hole 139 may extend entirely around the needle 22 forming an annular groove or around only a portion of the needle 22. The needle 22 may comprise more than one recess, opening, or hole 139. The multiple recesses, openings, or holes 139 are disposed at radial locations around the outer surface of the needle 22 that correspond to the radial spacing of the arms 135, 137 around the inner surface of the dilator 30.
The pairs of arms 135, 137 extend from the dilator 30 towards the needle 22. Each pair of arms 135, 137 is biased towards the needle 22 and is illustrated in a compressed or unlocked state in FIG. 8A. In the unlocked state or position, the recess, opening, or hole 139 in the needle 22 is not axial aligned with the arms 135, 137 of the locking mechanism 133. A healthcare provider can move the needle 22 with respect to the dilator 30 in both proximal and distal directions as long as the recess, opening, or hole 139 in the needle 22 stays on the proximal side of the locking mechanism 133 as is illustrated in FIG. 8B. Each pair of arms 135, 137 gently presses against the outer surface of the needle 22 as the needle 22 slides within the dilator 30 when the arms are in the unlocked state. Each pair of arms 135, 137 can rotate or bend to reach a locked state when the arms 135, 137 are axially aligned with the recess, opening, or hole 139.
In the illustrated embodiment, each arm of each pair of arms 135, 137 rotates towards the other arm between the unlocked position and the locked position. The arms 135, 137 need only be sufficiently biased so that when the arms 135, 137 align with the hole 139 their distal ends abut against a portion of the perimeter of the recess, opening, or hole 139. In the locked position, the distal ends of the arms 135, 137 are disposed within the recess, opening, or hole 139 in the needle 22.
The recess, opening, or hole 139 in the needle 22 locally increases a gap located between an outside surface of the needle 22 and an inside surface of the dilator 30 a sufficient amount to allow the arms 135, 137 to flex from their biased or unlocked state towards the locked position. FIG. 8B illustrates the pair of arms 135 of the locking mechanism 133 of FIG. 8A in a locked state. When one or both of the pair of arms 135, 137 is in the locked position the needle 22 is inhibited from relative axial movement with respect to the dilator 30 in both proximal and distal directions.
In the unlocked state Illustrated in FIG. 8A, the arms 135, 137 are biased to contact the needle 22 but not substantially interfere with movement of the needle 22 through the dilator 30. The arms 135, 137 are sized in their unbiased or locked state to inhibit movement of the needle 22 through the dilator 30. The biasing of the arms 135, 137 moves the arms 135, 137 from the unlocked position illustrated in FIG. 8A to the locked position illustrated in FIG. 8B.
Each pair of arms 135, 137 can separately move to the locked position when the pair of arms 135, 137 is axially aligned with the recess, opening, or hole 139 in the needle 22. Once in the locked position, the size and shape of the pair of arms 135, 137 inhibit movement back to the unlocked position.
FIG. 9A is a schematic, enlarged cross-sectional view of a locking mechanism 141 configured in accordance with an additional embodiment of the present invention. When engaged, the locking mechanism 141 inhibits movement of the needle 22 with respect to the dilator 30 in both directions. The embodiment of the locking mechanism 141 illustrated in FIG. 9A comprises a protrusion 143.
The locking mechanism 141 is illustrated on the dilator 30. However, the needle 22 may instead comprise the locking mechanism 141. In the illustrated embodiment, the needle 22 comprises a recess, opening, or hole 145 which interacts with the locking mechanism 141 of the dilator 30 when the needle 22 is sufficiently retracted into the dilator 30. The receptacle, recess, opening, or hole 145 may extend entirely around the needle 22 forming an annular groove or around only a portion of the needle 22. The needle 22 may comprise more than one recess, opening, or hole 145.
The protrusion 143 extends from the dilator 30 towards the needle 22 and is biased towards the needle 22. FIG. 9A illustrates the protrusion 143 in a compressed or unlocked state. In the unlocked state or position, the recess, opening, or hole 145 in the needle 22 is not axial aligned with the protrusion 143 of the locking mechanism 141. A healthcare provider can move the needle 22 with respect to the dilator 30 in both proximal and distal directions as long as the recess, opening, or hole 145 in the needle 22 stays on the proximal side of the locking mechanism 141 as is illustrated in FIG. 9A. The protrusion 143 gently presses against the outer surface of the needle 22 as the needle 22 slides within the dilator 30 when the locking mechanism 141 is in the unlocked state. At least a portion of the protrusion 143 can extend to reach a locked state when the protrusion 143 is axially aligned with the recess, opening, or hole 145.
The protrusion 143 need only be sufficiently biased so that when the protrusion 143 aligns with the hole 145 its distal end abuts against a portion of the perimeter of the recess, opening, or hole 145. In the locked position, the distal end of the protrusion 143 is disposed within the recess, opening, or hole 145 in the needle 22.
The recess, opening, or hole 145 in the needle 22 locally increases a gap located between an outside surface of the needle 22 and an inside surface of the dilator 30 a sufficient amount to allow the protrusion 143 to flex or extend from its biased or unlocked state towards the locked position. FIG. 9B illustrates the protrusion 143 of the locking mechanism 141 of FIG. 9A in a locked state. When the protrusion 143 is in the locked position the needle 22 is inhibited from relative axial movement with respect to the dilator 30 in both proximal and distal directions.
In the unlocked state Illustrated in FIG. 9A, the protrusion 143 is biased to contact the needle 22 but not substantially interfere with movement of the needle 22 through the dilator 30. The protrusion 143 is sized in its unbiased or locked state to inhibit movement of the needle 22 through the dilator 30. The biasing of the protrusion 143 moves the distal end of the protrusion from the unlocked position illustrated in FIG. 9A to the locked position illustrated in FIG. 9B.
FIG. 10A is a schematic, enlarged cross-sectional view of a locking mechanism 147 configured in accordance with a further embodiment of the present invention. When engaged, the locking mechanism 141 inhibits movement of the needle 22 with respect to the dilator 30 in both directions. The embodiment of the locking mechanism 141 illustrated in FIG. 10A comprises a detent 149.
The locking mechanism 147 is illustrated on the dilator 30. However, the needle 22 may instead comprise the locking mechanism 147. In the illustrated embodiment, the needle 22 comprises a recess, opening, or hole 151 which interacts with the locking mechanism 149 of the dilator 30 when the needle 22 is sufficiently retracted into the dilator 30. The receptacle, recess, opening, or hole 151 may extend entirely around the needle 22 forming an annular groove or around only a portion of the needle 22. The needle 22 may comprise more than one recess, opening, or hole 151.
The detent 149 extends from the dilator 30 towards the needle 22 and rides in an axial groove in the needle 22. The proximal end of the groove connects with the hole 151. FIG. 10A illustrates the detent 149 in an unlocked state. In the unlocked state or position, the recess, opening, or hole 151 in the needle 22 is not axial aligned with the detent 149 of the locking mechanism 147. A healthcare provider can move the needle 22 with respect to the dilator 30 in both proximal and distal directions as long as the recess, opening, or hole 151 in the needle 22 stays on the proximal side of the locking mechanism 147 as is illustrated in FIG. 10A. The detent 149 rides in the groove in the outer surface of the needle 22 as the needle 22 slides within the dilator 30 when the locking mechanism 147 is in the unlocked state. The detent 149 and groove further inhibit relative rotation of the needle 22 with respect to the dilator 30. The detent 149 reaches a locked state when the detent 149 is axially aligned with the recess, opening, or hole 151.
The recess, opening, or hole 151 in the needle 22 locally increases a gap located between a bottom surface of the groove in the needle 22 and an inside surface of the dilator 30 a sufficient amount to allow the detent 149 to flex or extend from a biased or unlocked state towards the locked position. FIG. 10B illustrates the detent 149 of the locking mechanism 147 in the unlocked state. While not illustrated, when the detent 149 is in the locked position the needle 22 is inhibited from relative axial movement with respect to the dilator 30 in both proximal and distal directions.
In the unlocked state illustrated in FIGS. 10A and 10B, the detent 149 is slightly biased to contact the bottom of the groove in the needle 22 but not to substantially interfere with movement of the needle 22 through the dilator 30. The detent 149 is sized in its unbiased or locked state to inhibit movement of the needle 22 through the dilator 30.
FIG. 11 is an enlarged exploded view of a dilator hub and locking plate assembly 153 configured in accordance with an additional preferred embodiment of the present invention. The assembly 153 includes a dilator hub 155 and one or more fingers or tangs 162. The one or more fingers or tangs 162 are spaced and sized such that they enter or snap into the side hole or holes in the needle 22 when the needle 22 is retracted. In some applications, a single finger or tang 162 is employed.
The one or more fingers or tangs 162 inhibit the bevel tip 108 disposed on the distal portion 106 of the needle 22 from being advanced beyond the distal end of the dilator 30 once the dilator 30 has been advanced over the needle 22 during use. The dilator 30 thus sheaths the sharp bevel tip 108 of the needle 22 to inhibit accidental needle sticks from occurring.
The one or more fingers or tangs 162 may be integrated into the dilator hub 155 or part of a separate structure that is combined with the dilator hub 155. In the embodiment illustrated in FIG. 11, the one or more fingers or tangs 162 are formed on a separate structure in the form of a locking plate 157(a)-(c). In this way, the locking plate 157(a)-(c) comprises the one or more fingers or tangs 162. Exemplary locking plates 157(a)-(c) are illustrated in FIGS. 12A-12C. Of course the structure of the locking plates 157(a)-(c) is not limited to the illustrated embodiments. For example, the locking plate 157 could be configured to include one or more of the locking mechanisms illustrated in FIGS. 7A, 8A, 9A, and 10A. For embodiments that have the one or more fingers or tangs 162 integrated into the dilator 155, the assembly 153 need not include a separate locking plate 157.
The dilator hub 155 and locking plate 157(a)-(c) may be separately manufactured and assembled as is illustrated in FIG. 11 or manufactured as a unitary assembly. The dilator hub 155 and locking plate 157(a)-(c) may be manufactured from the same or different materials, including, for example, plastics, metals, combinations thereof, and other materials. The locking plate 157 can be co-molded within the dilator hub 155 to form a unitary assembly. For example, a metal locking plate 157 can be molded into a plastic dilator hub 155. As explained above, a separate structure in the form of the locking plate 157 is for the In some applications, the locking plates 157(a)-(c) are movable with respect to the dilator hub 155 between unlocked and locked positions.
The dilator hub 155 is similar to the dilator hub 32 illustrated in FIG. 3A except that the dilator hub 155 is configured to slideingly receive the one or more locking plates 157(a)-(c) through one or more slots 158(a)-(c). While multiple locking plates 157(a)-(c) and slots 158(a)-(c) are illustrated in FIG. 11, only a single locking plate 157(a)-(c) and slot 158(a)-(c) can inhibit movement of the needle 22. In some applications, multiple locking plates 157(a)-(c) are inserted from different sides of the dilator hub 155 so that the fingers or tangs 162 from the locking plates 157(a)-(c) combine to completely surround the needle 22 even though separately the tangs or fingers 162 of each locking plate 157 would not surround the needle 22. The slot 158(a)-(c) need not be arranged perpendicular to the axis of the needle 22 or located in a specific side or surface of the dilator hub 155 as is illustrated in FIG. 11. Multiple locking plates 157(a)-(c) may be inserted into a single slot 158.
A healthcare provider slides the locking plate 157(a)-(c) from an unlocked position to a locked position relative to the dilator hub 155. The locking plate 157(a)-(c) may be completely removed from the slot 158(a)-(c) or partially inserted into the slot 158(a)-(c) when in the unlocked position. When the locking plate 157(a)-(c) is in the locked position, the needle 22 is disposed in a hole or center region 160 of the locking plate 157(a)-(c). The small size of the guide wire 120 inside the needle 22 does not affect the locking feature of the assembly.
FIG. 12A is an enlarged view of an embodiment of a locking plate 159 that can be used with the dilator hub 155 shown in FIG. 11. The locking plate 159 comprises a hole 160 surrounded by one or more fingers or tangs 162. An opening 164 extends from an outer perimeter of the locking plate 159 to the hole 160. The opening 164 permits the locking plate 159 to be inserted into the dilator hub 155 after the needle 22 is inserted through the dilator hub 155. The needle 22 passes through the opening 164 as the locking plate 159 is slid into the slot 158 and eventually enters the hole 160 when the locking plate 159 is in the locked position or state. Since the one or more fingers or tangs 162 do not extend entirely around the needle 22 when the needle 22 is inserted through the dilator hub 155, preferably the one or more side holes, receptacles, or annular groove in the needle 22 extend or are spaced radially about the needle 22 so that one of the fingers or tangs 162 will catch the one or more side holes, receptacles, or annular groove when the one or more side holes, receptacles, or annular groove passes through the locking plate 159.
When in the locked position, at least one of the distal ends of the fingers or tangs 162 extends a sufficient distance toward the needle 22 to enter a hole or slot in the needle 22 and inhibit further axial movement of the needle 22. In some applications, the hole or slot in the needle 22 falls onto the finger or tang 162. The hole may be the one or more side openings 34 in the side wall of the needle 22 or the receptacle, recess, opening, or hole 131, 139, 145, and 151 illustrated in, for example, FIGS. 7A, 8A, 9A, and 10A, respectively. In some applications, the receptacle, recess, opening, or hole 131, 139, 145, and 151 is the same structure as the one or more side openings 34.
FIG. 12B is an enlarged view of another embodiment of a locking plate 161 that can be used with the dilator hub 155 shown in FIG. 11. The locking plate 161 comprises a hole 160 surrounded by one or more fingers or tangs 162. An opening 164 extends from an outer perimeter of the locking plate 161 to the hole 160. The opening 164 permits the locking plate 161 to be inserted into the dilator hub 155 after the needle 22 is inserted through the dilator hub 155. The needle 22 passes through the opening 164 as the locking plate 161 is slid into the slot 158 and eventually enters the hole 160 when the locking plate 161 is in the locked position or state.
Since the one or more fingers or tangs 162 do not extend entirely around the needle 22 when the needle 22 is inserted through the dilator hub 155, preferably the one or more side holes, receptacles, or annular groove in the needle 22 extend or are spaced radially about the needle 22 so that one of the fingers or tangs 162 will catch the one or more side holes, receptacles, or annular groove when the one or more side holes, receptacles, or annular groove passes through the locking plate 161.
FIG. 12C is an enlarged view of an additional embodiment of a locking plate 163 that can be used with the dilator hub 155 shown in FIG. 11. The locking plate 163 comprises a hole 160 surrounded by one or more fingers or tangs 162. Unlike the embodiments illustrated in FIGS. 12A and 12B, the locking plate 163 has a closed pedal 166 instead of an opening. Further, the fingers or tangs 162 extend all the way around the needle 22. When the needle 22 passes through the dilator hub 155, the side hole in the needle 22 will be caught by the fingers or tangs 162 irrespective of whether the needle 22 is rotated relative to the dilator hub 155.
In this embodiment, the locking plate 163 is inserted in the dilator hub 155 before the needle 22 is axially inserted into the dilator hub 155. Since the fingers or tangs 155 extend entirely around the needle 22, a sheath or mandrel temporarily covers the side hole in the needle 22 to allow the needle 22 to be assembled through the dilator hub 155. Once assembled, the sheath or mandrel is removed from the needle 22.
FIGS. 13A-13D are enlarged views of perimeter shapes that the locking plate 157(a)-(c) can have in accordance with additional embodiments of the present invention. Any of the perimeter shapes illustrated in FIGS. 13A-D can be added to any of the locking plates 159, 161, 163. Of course the perimeter shapes are not limited to the illustrated embodiments. In some applications, the perimeter shape is selected to prevent the locking plate 157 from being removed from the dilator hub 155 or merely inhibit the locking plate 157 from falling out of the dilator hub 155.
The slot 158(a)-(c) in the dilator hub 155 would include corresponding shaped surfaces which engage with the perimeter shape 165, 167, 169 of the locking plate to inhibit the healthcare provider from removing the locking plate from the dilator hub 155 once the locking plate 157 has been slid to the locked position. In this way, the healthcare provider is prevented from accidently removing the locking plate and releasing the needle 22.
The embodiments herein described are comprised of conventional, biocompatible materials. For example, the needle preferably consists of a rigid polymer or a metal such as stainless steel, nitinol, or the like. The other elements can be formed of suitable polymeric materials, such as nylon, polyethylene, high-density polyethylene, polypropylene, fluoropolymers and copolymers such as perfluoro (ethylene-propylene) copolymer, polyurethane polymers or co-polymers.
As noted above, the present access device can be used to place a catheter at other locations within a patient's body. Thus, for example, but without limitation, the access device can be used with a variety of catheters to drain fluids from abscesses, to drain air from a pneumotorax, and to access the peritoneal cavity. In such applications, body fluids flow into the viewing space to indicate when the needle has been properly placed.
Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the disclosure.

## Claims

1. An access device for placing a medical article within a body space, comprising:
a needle section comprising an elongated needle body, a sharp distal tip, a side opening, and a first locking structure, the side opening in communication with an interior of the needle section such that a body fluid can flow through from the distal tip through the side opening, and the first locking structure being disposed proximal of the side opening; and
a medical article section coaxially disposed and slideable over the needle body, the medical article section comprising a tubular portion and a second locking structure,
wherein the first locking structure and the second locking structure form a locking apparatus configured to move into a locked position from an unlocked position to arrest axial movement of the needle body at least in the distal direction once the distal tip of the needle body is drawn into the medical article section to protect the distal tip.

2. The access device of claim 1, wherein the first locking structure comprises a receptacle or hole.

3. The access device of claim 1, wherein the first locking structure comprises at least one of a post, tooth, or prong.

4. The access device of claim 3, wherein the second locking structure comprises an axial groove configured to receive the first locking structure to inhibit relative rotation of the needle section with respect to the medical article section.

5. The access device of claim 1, wherein the second locking structure comprises a receptacle or hole.

6. The access device of claim 1, wherein the second locking structure comprises at least one of a post, tooth, or prong.

7. The access device of claim 6, wherein the first locking structure comprises an axial groove configured to receive the second locking structure to inhibit relative rotation of the needle section with respect to the medical article section.

8. The access device of claim 1, wherein at least one of the first and second locking structures is disposed at different radial locations.

9. The access device of claim 1, wherein the locking apparatus is configured to arrest axial movement of the needle body in the proximal direction when in the locked position.

10. The access device of claim 1, wherein the medical article section comprises a dilator section.

11. The access device of claim 10, further comprising a sheath section coaxially mounted on the tubular portion of the dilator section.

12. The access device of claim 1, wherein the first locking structure is disposed within the medical article section.

13. The access device of claim 1, wherein the second locking structure is disposed within the medical article section.