Catheter placement device including guidewire and catheter control elements

Information

  • Patent Grant
  • 9950139
  • Patent Number
    9,950,139
  • Date Filed
    Friday, May 1, 2015
    9 years ago
  • Date Issued
    Tuesday, April 24, 2018
    6 years ago
Abstract
An insertion tool for inserting a catheter into a patient's body is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component. Guidewire and catheter locking systems are also disclosed.
Description
BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed to an insertion tool for inserting a catheter or other tubular medical device into a body of a patient. The insertion tool in one embodiment unifies needle insertion, guidewire advancement, and catheter insertion in a single device to provide for a simple catheter placement procedure.


In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. An advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component.


In one embodiment the catheter advancement assembly further includes a handle that is initially and removably attached to a hub of the catheter within the housing. Distal movement of handle by a user in turn distally moves the catheter distally from the housing. The handle can include a needle safety component for isolating a distal tip of the needle when the needle is removed from the catheter and the distal tip received into the handle. In addition, various guidewire and catheter advancement assemblies are disclosed herein.


In yet another embodiment, various features are included with the insertion tool, including: actuation of the guidewire and catheter advancement assemblies without moving the hand of the user that grasps the insertion tool during the catheter insertion procedure; selective advancement of one of the guidewire or catheter based upon previous advancement of the other; and guidewire blunting features.


These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter.





BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:



FIGS. 1A and 1B are various views of a catheter insertion device according to one embodiment;



FIGS. 2A and 2B are various exploded views of the catheter insertion device of FIGS. 1A and 1B;



FIGS. 3A and 3B show various views of one stage of use of the catheter insertion tool of FIGS. 1A and 1B according to one embodiment;



FIGS. 4A and 4B show various views of one stage of use of the catheter insertion tool of FIGS. 1A and 1B according to one embodiment;



FIGS. 5A and 5B show various views of one stage of use of the catheter insertion tool of FIGS. 1A and 1B according to one embodiment;



FIGS. 6A and 6B show various views of one stage of use of the catheter insertion tool of FIGS. 1A and 1B according to one embodiment;



FIGS. 7A and 7B show various views of one stage of use of the catheter insertion tool of FIGS. 1A and 1B according to one embodiment;



FIG. 8 shows one stage of use of the catheter insertion tool of FIGS. 1A and 1B according to one embodiment;



FIG. 9 shows one stage of use of the catheter insertion tool of FIGS. 1A and 1B according to one embodiment;



FIGS. 10A-10C shows various views of a needle safety component and environment for a catheter insertion tool, according to one embodiment;



FIGS. 11A-11D are various views of a catheter insertion device according to one embodiment;



FIGS. 12A and 12B are various views of a portion of the catheter insertion device of FIGS. 11A-11D;



FIGS. 13A and 13B are various views of a portion of the catheter insertion device of FIGS. 11A-11D;



FIGS. 14A-14F show various stages of use of the catheter insertion tool of FIGS. 11A-11D according to one embodiment;



FIGS. 15A and 15B are various views of a catheter insertion device according to one embodiment;



FIG. 16 is a cross sectional side view of an integrated guidewire/dilator for use with the catheter insertion device of FIGS. 15A and 15B;



FIGS. 17A-17C are various views of a slotted needle for use with the catheter insertion device of FIGS. 15A and 15B according to one embodiment;



FIG. 18 is a cross sectional side view of a portion of the catheter insertion device of FIGS. 15A and 15B;



FIG. 19 shows one stage of use of the catheter insertion tool of FIGS. 15A and 15B according to one embodiment;



FIGS. 20A and 20B show one stage of use of the catheter insertion tool of FIGS. 15A and 15B according to one embodiment;



FIGS. 21A and 21B show one stage of use of the catheter insertion tool of FIGS. 15A and 15B according to one embodiment;



FIG. 22 shows one stage of use of the catheter insertion tool of FIGS. 15A and 15B according to one embodiment;



FIG. 23 shows one stage of use of the catheter insertion tool of FIGS. 15A and 15B according to one embodiment;



FIG. 24 shows one stage of use of the catheter insertion tool of FIGS. 15A and 15B according to one embodiment;



FIGS. 25A and 25B shows various views of a needle distal tip and guidewire blunting design according to one embodiment;



FIG. 26 is a perspective view of a needle distal tip design according to one embodiment;



FIG. 27 is a perspective view of a catheter insertion tool according to one embodiment;



FIG. 28 is a cross sectional view of a catheter insertion tool according to one embodiment;



FIGS. 29A and 29B are various views of a catheter insertion tool according to one embodiment;



FIG. 30 is a perspective view of a catheter insertion tool according to one embodiment;



FIG. 31 is a perspective view of a catheter insertion tool according to one embodiment;



FIGS. 32A-32I are various views of a configuration of a catheter insertion tool during use, according to one embodiment;



FIGS. 33A-33C are various views of a safety needle component according to one embodiment;



FIG. 34 is an exploded view of a catheter insertion device according to one embodiment;



FIG. 35 is a perspective view of a portion of a guidewire lever according to one embodiment;



FIGS. 36A and 36B are cutaway views of a proximal portion of the catheter insertion device of FIG. 34;



FIG. 37 is a perspective view of a proximal portion of the top housing portion of the catheter insertion device of FIG. 34;



FIG. 38 is a cutaway view of a proximal portion of the catheter insertion device of FIG. 34;



FIGS. 39A and 39B are various views of a needle safety component according to one embodiment;



FIGS. 40A-40D are various views of the needle safety component of FIGS. 39A and 39B and an accompanying carriage;



FIGS. 41A and 41B are cutaway views of a proximal portion of the catheter insertion device of FIG. 34;



FIG. 42 is a cross-sectional view of a guidewire for use with a catheter insertion tool according to one embodiment;



FIG. 43 is a side view of the guidewire of FIG. 42 partially disposed within a needle;



FIG. 44 is a cross-sectional view of a distal portion of a catheter tube including a reinforcement component according to one embodiment;



FIGS. 45A and 45B show various stages of manufacture of the catheter tube of FIG. 44;



FIG. 46 is a cross-sectional view of a distal portion of a catheter tube including a reinforcement component according to one embodiment;



FIGS. 47A and 47B show cross-sectional views of distal portions of catheter tubes including a reinforcement component according to additional embodiments;



FIGS. 48A-48F are various views of a catheter insertion tool according to one embodiment;



FIG. 49 is an exploded view of the insertion tool of FIGS. 48A-48F;



FIGS. 50A and 50B show various views of the insertion tool of FIGS. 48A-48F;



FIG. 51 is a top view of a guidewire advancement assembly and a catheter advancement assembly of FIGS. 48A-48F;



FIG. 52 is a perspective view of the guidewire advancement assembly of the insertion tool of FIGS. 48A-48F;



FIGS. 53A-53B show details of the operation of the guidewire advancement assembly of FIG. 52;



FIG. 54 is a perspective view of the insertion tool of FIGS. 48A-48F in one state;



FIG. 55 is a top view of the guidewire advancement assembly of FIG. 52;



FIG. 56A-56C are various views of a portion of a catheter advancement assembly of the insertion tool of FIGS. 48A-48F;



FIGS. 57A and 57B are various views of the distal portion of the insertion tool of FIGS. 48A-48F;



FIGS. 58 and 59 shows various views of the catheter advancement assembly of the insertion tool of FIGS. 48A-48F;



FIG. 60 is a perspective view of the catheter advancement assembly of the insertion tool of FIGS. 48A-48F;



FIG. 61 is a perspective view of a handle of a catheter advancement assembly according to one embodiment;



FIG. 62 is a side view of the handle of FIG. 61;



FIG. 63 is a perspective view of a handle of a catheter advancement assembly according to one embodiment;



FIG. 64 is a perspective view of a handle of a catheter advancement assembly according to one embodiment;



FIG. 65 is a side view of the handle of FIG. 64; and



FIGS. 66A-66C are various views of an insertion tool according to one embodiment.





DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale.


For clarity it is to be understood that the word “proximal” refers to a direction relatively closer to a clinician using the device to be described herein, while the word “distal” refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”


Embodiments of the present invention are generally directed to a tool for assisting with the placement into a patient of a catheter or other tubular medical device. For example, catheters of various lengths are typically placed into a body of a patient so as to establish access to the patient's vasculature and enable the infusion of medicaments or aspiration of body fluids. The catheter insertion tool to be described herein facilitates such catheter placement. Note that, while the discussion below focuses on the placement of catheters of a particular type and relatively short length, catheters of a variety of types, sizes, and lengths can be inserted via the present device, including peripheral IV's intermediate or extended-dwell catheters, PICC's, central venous catheters, etc. In one embodiment, catheters having a length between about 2.5 inches and about 4.5 inches can be placed, though many other lengths are also possible. In another embodiment a catheter having a length of about 3.25 inches can be placed.


Reference is first made to FIGS. 1A-1B and 2A-2B, which depict various details regarding a catheter insertion tool (“insertion tool”), generally depicted at 10, according to one embodiment. As shown, the insertion tool 10 includes a housing 12 that in turn includes a top housing portion 12A separably mated with a bottom housing portion 12B. A needle hub 14 supporting a hollow needle 16 is interposed between the housing portions 12A and 12B. The needle 16 extends distally from the needle hub 14 so as to extend through the body of the insertion tool 10 and out a distal end of the housing 12. In another embodiment, the needle is at least partially hollow while still enabling the functionality described herein.


A notch 18 is defined through the wall of the needle 16 proximate the distal end thereof. The notch 18 enables flashback of blood to exit the lumen defined by the hollow needle 16 once access to the patient's vasculature is achieved during catheter insertion procedures. Thus, blood exiting the notch 18 can be viewed by a clinician to confirm proper needle placement in the vasculature, as will be explained further below.


The insertion tool 10 further includes a guidewire advancement assembly 20 for advancing a guidewire 22 through the needle 16 and into the vasculature of the patient once access by the needle has been achieved. The guidewire 22 is pre-disposed within the lumen of the needle 16, with a proximal end of the guidewire positioned proximate the proximal end of the needle hub 14, as best seen in FIGS. 1B and 2A. The guidewire advancement assembly 20 includes a guidewire lever 24 that selectively advances the guidewire in a distal direction during use of the insertion tool 10 such that the distal portion of the guidewire extends beyond the distal end of the needle 16. The guidewire lever 24 includes a lever tab 26 that engages the proximal end of the guidewire 22 so to push the guidewire through the lumen of the needle 16.


The guidewire advancement assembly 20 further includes a slide 28 that is slidably attached to the top housing portion 12A. Two tabs 24A of the guidewire lever 24 operably attach to the slide 28 so that selective movement by a user of the slide results in corresponding movement of the lever 24, and by extension, the guidewire 22. Engagement of the lever tabs 24A to the slide 28 also maintains attachment of the slide to the housing 12. Of course, other engagement schemes to translate user input to guidewire movement could also be employed. Suitable tracks are included in the top housing portion 12A to enable sliding movement of the slide 28 and the lever 24, including a track 34 extending to the distal end of the housing 12.


The slide 28 includes two arms 30 that wrap partially about rails 32 defined by the housing 12. In particular, during initial distal advancement of the slide 28, the arms 30 slide on a bottom housing rail 32A, best seen in FIG. 5B. During further distal advancement of the slide 28, the arms 30 slide past the bottom housing rail 32A and on to a top housing rail 32B, best seen in FIGS. 2A and 3A. With the arms 30 of the slide 28 no longer engaged with the bottom housing rail 32A, the two housing portions 12A and 12B are able to separate, as will be described further below.


The guidewire lever 24 includes a locking arm 36 resiliently disposed so as to spring up and engage an extension 36A defined in the interior of the top housing portion 12A when the slide 28 has been fully slid distally. This prevents inadvertent retraction of the guidewire 22 once distally extended, which could otherwise cause unintended severing of a distal portion of the guidewire by the distal tip of the needle 16 during insertion procedures. Note that engagement of the locking arm 36 with the extension 36A can provide tactile and/or audible feedback to the user in one embodiment so as to indicate full distal extension of the guidewire 22.


The insertion tool 10 further includes a catheter advancement assembly 40 for selectively advancing in a distal direction a catheter 42, pre-disposed in the housing 12, and including a catheter tube 44 and a hub 46 at a proximal end thereof. As seen in FIGS. 1A and 1B, the catheter 42 is partially and initially pre-disposed within a volume defined by the housing 12 such that the lumen of the catheter tube 44 is disposed over the needle 16, which in turn is disposed over the guidewire 22, as mentioned.


In particular, the catheter advancement assembly 40 includes a handle 48 that defines a base 48A and two arms 50 extending from the handle base. Each arm 50 defines a grip surface 50A, finger grabs 50B, and one of two teeth 50C. The grip surfaces 50A and finger grabs 50B enable the handle to be grasped or contacted by a user in order to selectively advance the catheter 42 in a distal direction during use of the insertion tool 10 to insert the catheter into the body of the patient. The teeth 50C engage corresponding raised surfaces on the hub 46 so as to removably connect the handle 48 to the catheter 42.


Additional components are included in relation to the handle 48 of the catheter advancement assembly 40. A plug, or valve 52, is interposed between the handle base 48A and the catheter hub 46 to prevent blood spillage when the catheter is first introduced into the patient vasculature. A safety housing 54, including a needle safety component 56 therein, is removably attached to the handle 48 between the arms 50. Specifically, protrusions 60 included on the inner surfaces of the handle arms 50 engage with corresponding recesses 62 (FIG. 10A) defined in the safety housing 54 to removably secure the safety housing to the handle 48. A cap 58 supports the needle safety component 56 and covers the end of the safety housing 54. As shown in FIG. 1B, the needle 16 initially extends through the aforementioned components in the order as shown in FIG. 2B. Further details regarding the operation of these components are given below.


Note that in one embodiment the outer diameters of the needle 16 and the catheter tube 44 are lubricated with silicone or other suitable lubricant to enhance sliding of the catheter tube with respect to the needle and for aiding in the insertion of the catheter into the body of the patient.


The insertion tool 10 further includes a support structure 70 for stabilizing the needle 16 proximate its point of exit from the housing 12. In the present embodiment, the support structure 70 includes an interface 72 of the top housing portion 12A and bottom housing 12B that is shaped to closely match the round shape of the needle 16 and catheter tube 44. The interface 72 stabilizes the needle 16 so as to prevent excessive “play” in the needle, thus improving user accuracy when initially accessing the vasculature of the patient.


As best seen in FIG. 2A, the top housing 12A, the needle hub 14, and the bottom housing 12B include engagement features 68 to maintain attachment of the proximal end of the housing 12 even when more distal portions of the housing are separated, discussed below. Note, however, that various types, sizes, and numbers of engagement features can be employed to achieve this desired functionality.



FIGS. 3A-9 depict various stages of use of the insertion tool 10 in placing the catheter 42 in the vasculature of a patient. For clarity, the various stages are depicted without actual insertion into a patient being shown. With the insertion tool 10 in the configuration shown in FIG. 1A, a user grasping the insertion tool 10 first guides the distal portion of the needle 16 through the skin at a suitable insertion site and accesses a subcutaneous vessel. Confirmation of proper vessel access having been achieved is evident via blood flash, i.e., the presence of blood between the outer diameter of the needle 16 and the inner diameter of the catheter tube 44 due to blood passing out the notch 18 from the hollow interior of the needle. Note that in one embodiment, the presence of blood in the safety housing 54, which in one embodiment is a translucent housing, can serve as a secondary blood flash indicator due to blood entering the housing from the needle 16 when the vessel is accessed.


After needle access to the vessel is confirmed, the guidewire advancement assembly 20 is actuated, wherein the slide 28 is advanced by the finger of the user to distally advance the guidewire 22 (FIGS. 3A and 3B), initially disposed within the hollow needle 16. Note that the guidewire is distally advanced by the lever 24, which is operably attached to the slide 28. Note also that during distal advancement of the slide 28, the slide arms 30 thereof travel along the rails 32 on either side of the housing 12: first the bottom housing rails 32A, then the top housing rails 32B.


Distal guidewire advancement continues until the slide 28 has been distally slid its full travel length, resulting in a predetermined length of the guidewire 22 extending past the distal end of the needle 16, as shown in FIGS. 4A and 4B. In one embodiment, further distal advancement of the slide 28 is prevented by contact of the lever tab 26 with a distal portion of the needle hub 14, as shown in FIG. 4B. FIGS. 5A and 5B show that, upon full distal advancement of the slide 28, the slide arms 30 thereof are no longer engaged with the bottom housing rails 32A, but rather with only the top housing rails 32B. This in turn enables the housing portions 12A and 12B to separate, as seen further below.


As seen in FIGS. 5A and 5B, once the guidewire 22 has been fully extended within the vessel of the patient (FIGS. 4A and 4B), the catheter advancement assembly 40 is actuated, wherein the handle 48 is distally advanced by the user to cause the catheter tube 44 to slide over distal portions of the needle 16 and guidewire 22 and into the patient's vasculature via the insertion site. FIGS. 6A and 6B show that, as the catheter is advanced via the handle 48, the housing portions 12A and 12B are easily separated so as to enable the catheter hub 46 to exit the distal end of the housing 12 and for the catheter to be inserted into the patient vasculature to a suitable degree.


Note that, as shown in FIGS. 7A and 7B, during removal of the catheter from within the housing 12 of the insertion tool 10, the catheter slides distally along the needle 16 until the distal needle tip is received into the safety housing 54 and engaged with the needle safety component 56. FIG. 8 shows that the insertion tool 10 can then be separated from the catheter 42, leaving the handle 48 still attached to the catheter hub 46. As mentioned, the handle 48 includes the valve 52 interposed between the catheter hub 46 and the handle 48. Upon removal of the needle 16 and safety housing 54 from the catheter 42, the valve 52 occludes the catheter lumen so as to prevent inadvertent blood spillage from the catheter hub 46. As shown in FIG. 9, the handle 48 can be removed from engagement with the catheter hub 46 via pulling, twisting, etc., so as to disengage the teeth 50C of the handle from the hub. An extension leg can be attached to the catheter hub and the catheter 42 dressed down, per standard procedures. Then housing 12 and handle 48 of the insertion tool 10 can be discarded.



FIGS. 10A-10C give further details regarding the safety housing 54, as well as the needle safety component 56 and its interaction with the needle 16 in isolating the distal end thereof. As shown, the safety housing 54 is configured to enable the needle 16 to pass therethrough during use of the insertion tool 10, as has been described, exiting the housing via the extension 74 on the distal end of the housing. The cap 58 is placed into the proximal end of the safety housing 54 and is configured to support the needle safety component 56 such that he needle 16 initially passes through the safety housing, the cap, and the needle safety component. Note that the extension 74 of the safety housing 54 in the present embodiment extends into the valve 52 so as to open the valve during use of the insertion tool 10, which eliminates undesired friction between the valve and the needle.



FIG. 10C shows that the needle safety component 56 includes a bent body, or binding element 80 through which the needle initially extends, and a friction element 82. As seen in FIG. 10A, when the needle 16 is withdrawn from the catheter 42 (FIG. 8), the distal tip of the needle is withdrawn proximally through the extension 74 and past the distal portion of the needle safety component such that the needle is no longer in contact therewith. This enables the friction element 82 to cause the binding element 80 to cant slightly, thus binding the needle 16 in place and preventing its further travel with respect to the safety housing 54 and isolating the needle distal tip within the housing so as to prevent inadvertent needle sticks. In the present embodiment the friction element 82 includes a suitably sized O-ring. Suitable O-rings can be acquired from Apple Rubber Products, Lancaster, N.Y., for instance. Note that further details regarding the needle safety component, its operating principles, and similar devices are disclosed in U.S. Pat. Nos. 6,595,955, 6,796,962, 6,902,546, 7,179,244, 7,611,485, and 7,618,395, each of which is incorporated herein by reference in its entirety. Of course, other needle safety devices can be employed to isolate the distal end of the needle.


Reference is now made to FIGS. 11A-13B in describing a catheter insertion tool 110 according to one embodiment. Note that in this and succeeding embodiments, various features are similar to those already described in connection with the above embodiment. As such, only selected aspects of each embodiment to follow will be described.


The insertion tool 110 includes a housing 112 defined by a top housing portion 112A and a bottom housing portion 112B that together partially enclose the catheter 42. A needle hub 114 supporting a distally extending needle 116 is included for disposal within the housing 112 and positioned such that the catheter tube 44 of the catheter 42 is disposed over the needle. Note that partial enclosure of the catheter by the insertion tool in this and other embodiments enables a clinician to manipulate the insertion tool with hands that are closer to the distal end of the needle than what would otherwise be possible.



FIGS. 13A and 13B give further details regarding the needle hub 114, which is attached to the top housing portion 112A. A needle holder 126, included on a distal end of the needle hub 114, receives the proximal end of the needle 116 therein. The needle 116 is secured within the needle holder 126 via adhesive, welding, or other suitable manner. Extensions 128 are included on opposite sides of the needle holder 126 and are configured to be slidably received within corresponding slots 130 defined on the sides of the bottom housing portion 112B. Such engagement enables the bottom housing portion 112B to slide distally with respect to the top housing portion 112A.


A top rail 132 is included on the needle hub 114 and is configured to engage a corresponding slot 134 defined in the proximal portion of the top housing portion 112A so as to secure the needle hub to the top housing portion. A lock out arm 136 is also included with the needle hub 114 and positioned to engage the back plate 124 when the bottom housing portion 112B is slid distally to extend the guidewire from the needle 116, thus preventing its retraction. Note that the guidewire 122 initially distally extends from the back plate 124 and through the needle holder 126 and needle 116, as best seen in FIG. 11D.


A guidewire advancement assembly 120 is included to selectively advance a guidewire 122, initially disposed within the lumen of the needle, distally past the distal end of the needle 116. The guidewire advancement assembly 120 includes the bottom housing portion 112B to which the guidewire 122 is attached at a proximal back plate 124 thereof. As will be seen, the bottom housing portion 112B is distally slidable with respect to the top housing portion 112A to enable selective distal advancement of the guidewire 122.


The insertion tool 110 further includes a catheter advancement assembly 140 for selectively advancing the catheter 42 over the needle 116. The advancement assembly 140 includes a handle 146 initially and slidably disposed between the top and bottom housings 112A and 112B and removably attached to the hub 46 of the catheter 42. As best seen in FIGS. 12A and 12B, the handle 146 includes two arms 150 for allowing a user to selectively slide the handle in order to advance the catheter 42. The handle 146 further includes a recess 152 in which is placed a needle safety component 156 for isolating the distal tip of the needle 116 when the needle is withdrawn from the catheter 42. Further details regarding the needle safety component are disclosed in U.S. Pat. Nos. 6,595,955, 6,796,962, 6,902,546, 7,179,244, 7,611,485, and 7,618,395, each incorporated by reference above.


The insertion tool 110 further includes a support structure 170 for stabilizing the needle 116 proximate the distal end of the housing 112. The support structure 170 in the present embodiment includes two flaps 172 that are hingedly connected to the distal portion of the bottom housing portion 112B. When closed as seen in FIGS. 11D and 12A, the flaps 172 serve to stabilize the needle 116 to assist the user of the insertion tool 110 in inserting the needle into the patient. When open (FIG. 14D), the flaps 172 provide an opening to enable the catheter hub 46 to be removed from the distal end of the housing 112, as will be detailed further below. Before the bottom housing portion 112B is slid with respect to the top housing portion 112A, the flaps 172 are disposed in a track 174 defined by the top housing portion. Other types and configurations of support structures can also be employed. The insertion tool 110 further includes gripping surfaces 176 on either side of the housing 112 to aid in use of the tool during catheter insertion procedures, detailed below.



FIGS. 14A-14E depict various stages of use of the insertion tool 110 in inserting a catheter into a patient. With the insertion tool 110 in the configuration shown in FIG. 14A, vascular access is achieved with the needle 116 via user insertion of the needle into the patient at an insertion site. Confirmation of vessel access can be achieved via the observation of blood flashback via a distal notch in the needle 116, as described in the previous embodiment, or in other suitable ways.


Once the distal portion of the needle 116 is disposed within a vessel of the patient, the guidewire 122 is extended past the distal end of the needle and into the vessel by distally advancing the bottom housing portion 112B. Such advancement is achieved in the present embodiment by placing a user's fingers on the folded-up flaps 172 of the bottom housing portion 112B and pushing the flaps distally, thus extending the guidewire 122. The guidewire 122 is advanced until fully extended. The lock out arm 136 of the needle hub 114 then engages the back plate 124 of the bottom housing portion 112B and prevents retraction of the guidewire 122.


At this stage, the handle 146 of the catheter advancement assembly 140 is distally advanced, by a user grasping of one or both arms 150 thereof, so as to distally advance the catheter 42 through the insertion site and into the patient vasculature. This is shown in FIG. 14C, wherein the catheter tube 44 is shown distally advancing over the needle 116 and the guidewire 122.


As shown in FIG. 14D, continued distal advancement of the catheter 42 causes the catheter hub 146 to urge the flaps 172 to open, thus providing a suitable opening through which the hub may pass from the insertion tool housing 112. Note that the flaps 172 are shaped such that contact with the catheter hub 46 urges each flap to fold outward, as seen in FIG. 14D. Note also that the flaps 172 are no longer disposed within the track 174 due to full distal advancement of the guidewire 122 via finger pressure applied to the flaps 172 as described above.



FIG. 14E shows that, with the flaps no longer engaged within the track 174, the top housing portion 112A and bottom housing portion 112B are able to separate at the distal ends thereof such that the handle 146, still attached to the catheter hub 46, can separate from the housing 112. Though not shown at this stage, the needle safety component 156 disposed in the recess 152 of the handle 146 isolates the distal end of the needle 116. The handle 146 can then be manually removed from the catheter hub 46 (FIG. 14F), and placement and dressing of the catheter 42 can be completed. The insertion tool 110, including the needle 116 isolated by the needle safety component 156 of the handle 146, can be safely discarded.


Reference is now made to FIGS. 15A-18 in describing a catheter insertion tool 210 according to one embodiment. The insertion tool 210 includes a housing 212 defined by a top housing portion 212A and a bottom housing portion 212B that together partially enclose the catheter 42. A sliding needle hub 214 supporting a distally extending hollow needle 216 is slidably attached to the housing 212. In particular, the needle hub 214 includes tracks 214A that slidably engage corresponding rails 218 defined on the top and bottom housing portions 212A, 212B in a manner described further below. As shown in FIG. 15A, the needle hub 214 is positioned distally with respect to the housing 212 such that the needle 216 extends through a needle channel 224 (FIG. 18) and out a hole defined in a distal end of the top housing portion 212A so that the needle is positioned as shown in FIG. 15A.


As seen in FIG. 15A, the housing 212 of the insertion tool 210 encloses a portion of the catheter 42. An integrated guidewire/dilator 220 is included and disposed within the lumen of the catheter tube 44, as shown in FIGS. 15B and 16. The guidewire/dilator 220 includes a distal guidewire portion 220A and a proximal dilator portion 220B. So configured, the guidewire/dilator 220 can not only serve as a guidewire in directing the catheter tube 44 through the insertion site of the patient into the accessed vessel, but can dilate the insertion site in advance of catheter insertion therethrough. In other embodiment, no guidewire/dilator need be used. In one embodiment, it is appreciated that the guidewire/dilator 220 can proximally extend through the entire catheter 42 and include on a proximal end thereof a luer cap connectable to a proximal luer connector of the catheter. Note also that FIG. 15A shows a sterile bag 217 attached to the housing 212 so as to cover and isolate the proximal portion of the catheter 42. For clarity, the bag 217 is included only in FIG. 15A, but could be included with insertion tools of varying configurations so as to protect and isolate portions of the catheter.


As seen in FIGS. 17A-17C, the needle 216 includes a longitudinally extending needle slot 226 extending from a beginning point along the length of the needle to the distal end thereof. FIG. 17B shows that the slot 226 can be optionally wider in a proximal portion thereof relative to more distal slot portions. So configured, the needle slot 226 enables the guidewire/dilator 220 to be inserted into, slid relative to, and removed from the needle 216 during operation of the insertion tool 210, described below. Note that the needle slot can extend the entire length of the needle, in one embodiment.



FIG. 18 shows the manner of entry of the guidewire/dilator 220 into the slot 226 of the needle 216 according to one embodiment, wherein the guidewire/dilator extends distally along a guide channel 222 defined in the top housing portion 212A and into the hollow needle 216, which is disposed in the needle channel 224, via the needle slot. (The guide channel 222 is also seen in FIG. 15B.) In this way, the guidewire/dilator 220 can be distally slid through the hollow needle 216 so as to extend beyond the distal needle end while still being able to be removed from the needle via the slot 226 when the guidewire/dilator and needle are separated from one another, as will be seen.



FIG. 18 also shows a support structure 270 for stabilizing the needle 216, including an interface 272 defined by portions of the top housing portion 212A and the bottom housing portion 212B about the hole through which the needle extends. Of course, other support structures can be employed to provide stability to the needle to assist in inserting the needle into the patient vasculature. FIG. 19 shows details of a lockout 230 for the needle hub 214, included on the bottom housing portion 212B, for preventing further movement of the needle hub after it has been retracted, as described below.



FIGS. 19-24 depict various stages of use of the insertion tool 210 in inserting a catheter into a patient. With the insertion tool 210 in the configuration shown in FIG. 19, vascular access is achieved with the needle 216 via user insertion of the needle into the patient at an insertion site.


Once the distal portion of the needle 116 is disposed within a vessel of the patient, the guidewire/dilator 220 is manually fed through the hollow needle 216 so as to extend past the distal end of the needle and into the vessel. Such advancement is achieved in the present embodiment by distally moving the housing 212 and catheter 42 together while keeping the needle hub 214 stationary. The guidewire 122 is advanced distally a suitable distance, which in the present embodiment, includes advancement until a distal end of the housing 212 arrives at the skin insertion site.



FIGS. 20A and 20B show that after the guidewire/dilator 220 has been distally extended into the vessel, the needle 216 is retracted from the vessel by proximally sliding the needle hub 214 along rail portions 218A disposed on the top housing portion 212A. Proximal sliding of the needle hub 214 continues until the hub engages the rail portions 218B of the bottom housing portion 212B and is fully slid to the proximal end of the housing 212, as shown in FIGS. 21A and 21B. The needle hub 214 engages the lock out 230 (FIG. 20B) so as to prevent future distal movement of the needle hub or needle 216. In this position, the needle 216 is fully retracted into the insertion tool housing 212 such that the distal end of the needle is safely isolated from the user (FIG. 21B). Note that in one embodiment a needle safety component can be added to the insertion tool to further isolate the tip of the needle. Note that the distal portion of the guidewire/dilator 220 remains in the vessel of the patient, having been able to separate from the needle 216 during refraction thereof via the needle slot 226.


At this stage, the bottom housing portion 212B (FIG. 22) and the top housing portion 212A (FIG. 23) are removed from the catheter 42. The catheter 42 can then be inserted through the insertion site and into the vessel of the patient. Note that the guidewire/dilator 220 is still disposed within the catheter tube 44 and that the dilator portion assists the distal end of the catheter tube to enter the vessel by gradually enlarging the insertion site and the vessel entry point.


As mentioned, in one embodiment, the proximal portion of the catheter 42, including the hub 46 and connected extension leg, is covered by a sterile bag, which is attached to the housing 212. The sterile bag can be removed after the catheter is fully inserted into the patient vessel or can be removed when the housing portions 212A and 212B are removed. In FIG. 24, the guidewire/dilator 220 is then removed from the catheter 42 and the catheter dressed and finalized for use. The guidewire/dilator 220 and other portions of the insertion tool 210 are discarded.



FIGS. 25A and 25B depict details regarding a needle blunting system for isolating a distal end 316A of a hollow needle 316, according to one embodiment. As shown, the needle distal end 316A includes a bevel that is configured such that its cutting surfaces are disposed at an inner diameter 318 of the needle 316. Thus, when a suitably sized guidewire 320 is distally extended past the distal end 316A of the needle 316, the cutting surfaces of the needle are blocked by the proximity thereto of the guidewire, thus safely isolating the needle end from a user. In addition, blunting the distal end 316A of the needle 316 in this manner prevent the needle end from damaging sensitive inner walls of the vessel after the needle tip has been inserted herein. At this point, a distal end 44A of the catheter tube 44 can then be distally advanced over the needle 316 and guidewire 320. FIG. 26 depicts a needle end bevel 316A according to another embodiment, including an additional fillet component 319. Such a blunting system can be employed in one or more of the insertion tools described herein.


Reference is now made to FIG. 27 in describing a catheter insertion tool 410 according to one embodiment. The insertion tool 410 includes a housing 412 that partially encloses the catheter 42. A distally extending hollow needle 416 is disposed with the housing 412 such that the needle extends out the distal end of the housing 412


A guidewire advancement assembly 420 is shown for selectively advancing a guidewire 422, including a slide 428 that slides along a track 430 defined in the housing 412. The guidewire 422 is attached to the slide 428 and extends proximally within the housing 412 until it bends, forming a guidewire bend 422A, toward the distal end of the housing and passes into the hollow needle 416 via a proximal end 416A thereof for selective distal advancement past the distal end of the needle via user actuation of the slide. Distal advancement of the guidewire 422 out the distal end of the needle 416 is stopped when the guidewire bend 422A engages the needle proximal end 416A.


A catheter advancement assembly 440 is also shown for selectively advancing the catheter tube 44 over the needle 416, including a slide 448 that slides along the track 430, and a carriage 450 disposed within the housing 412 and operably connected to the slide 448. The carriage 450 is initially engaged with the catheter hub 46 such that distal sliding of the slide 448 causes the catheter to be distally advanced toward the distal housing end.


The insertion tool 410 further includes a support structure 470 for stabilizing the needle 416, including two doors 472 hingedly attached via pins to the distal end of the housing 412. The doors 472 serve to stabilize the needle 416 during insertion into the patient. Later, when the catheter tube 44 and catheter hub 46 are advanced distally by the slide 448, the doors 472 are opened, enabling the catheter 42 to pass through the doors and be separated by the user from the insertion tool 410. In the present embodiment, a wedge feature is included on the bottom surface of the slide 428, the wedge feature being configured to push the doors 472 open when the slide is slid distally, as described herein. Such a wedge or other suitable feature can be included in other embodiments described herein as well.


After separation from the insertion tool 410, the catheter 42 can then be advanced and placed as needed into the patient by the user. Note that, though none is shown, a needle safety component can be included for isolating the distal tip of the needle 416. In one embodiment, distal sliding of the guidewire slide 428 can partially open the doors 472 in preparation for catheter advancement.



FIG. 28 shows the insertion tool 410 including a support structure 480 according to another embodiment, wherein two half-conically shaped doors 482 are hingedly connected to the housing 412 (via living hinges or other suitable connective scheme) and configured to stabilize the needle 416. The carriage of the insertion tool 410 in FIG. 28 is also longer relative to that of FIG. 27. Thus, it is appreciated that various different support structures and configurations can be employed for stabilizing the needle at or near its exit point from the insertion tool housing.


Reference is now made to FIGS. 29A and 29B in describing a catheter insertion tool 510 according to one embodiment. The insertion tool 510 includes a housing 512 that partially encloses the catheter 42. A hollow needle 516 distally extends from a needle hub 514 that caps a proximal end of the housing 512 such that the needle extends out the distal end of the housing 512.


A guidewire advancement assembly 520 is shown for selectively advancing a guidewire 522, including a slide 528 that slides along a track 530 defined in the housing 512. The guidewire 522 is attached to the slide 528 and extends proximally within the housing 512 and out through a pigtail 524, attached to the proximal end of the housing 512, via a top one of two holes 514A defined in the needle hub 514. Near the proximal end of the pigtail 524, the guidewire 522 bends to form a U-shaped guidewire bend 522A and distally extends back into the housing 512 to pass into the hollow needle 516 via a bottom one of the two needle hub holes 514A, for eventual distal advancement out the distal end of the needle when the slide 528 is selectively actuated by a user. Such distal advancement of the guidewire 522 out the distal end of the needle 416 is stopped when the guidewire bend 522A abuts the holes 514A defined in the needle hub 514.


A catheter advancement assembly 540 is also shown for selectively advancing the catheter tube 44 over the needle 516, including a slide 548 that slides along the track 530, and a carriage 550 disposed within the housing 512 and operably connected to the slide. The carriage 550 can be initially engaged with the catheter hub 46 such that distal sliding of the slide 548 causes the catheter to be distally advanced toward the distal housing end. In the present embodiment a bulge 522B is included on the guidewire 522 such that, when the guidewire is distally advanced by user actuation of the (guidewire advancement) slide 528, the bulge is advanced and engages an internal portion of the (catheter advancement) slide 548. This in turn causes the slide 548 to be advanced as well, resulting in distal advancement of the catheter 42. Thus, the catheter can be advanced directly via the slide 548, or indirectly via the slide 528, in one embodiment.


The insertion tool 510 further includes a support structure 570 for stabilizing the needle 516, including a plug 572 that includes a plug hole 574 defined therein through which the needle 516 extends. The plug 572 is attached via the track 530 to the slide 528 and occludes the distal end of the housing 512, thus serving to stabilize the needle 516 that passes therethrough during needle insertion into the patient. Later, when the guidewire 522 is advanced distally by the slide 528, the plug 572 also distally advances out the housing 512, thus opening the housing distal end and enabling the catheter 42 to pass therethrough. The catheter 42 can then be separated by the user from the insertion tool 510 and advanced into final position by the user. Note that, though none is shown, a needle safety component can be included for isolating the distal tip of the needle 516. Note also that after the plug 572 is removed from its initial position in the housing 512, the catheter tube 44 and needle 516, no longer being constrained by the support structure plug hole 574, can axially relocate toward the center of the housing, in one embodiment. This holds true for the embodiments of FIGS. 30 and 31 as well.


Reference is now made to FIG. 30 in describing a catheter insertion tool 610 according to one embodiment. The insertion tool 610 includes a housing 612 that partially encloses the catheter 42. A hollow needle 616 distally extends from a needle hub 614 that caps a proximal end of the housing 612 such that the needle extends out the distal end of the housing 612. The needle 616 includes a longitudinally extending proximal slot 616A that extends from the proximal end of the needle 616 to a distal end 616B of the slot.


A guidewire advancement assembly 620 is shown for selectively advancing a guidewire 622, including a slide 628 that slides along a track 630 defined in the housing 612. The guidewire 622 is attached to the slide 628 and extends proximally within the housing 612 until it bends, forming a U-shaped guidewire bend 622A, toward the distal end of the housing and passes into the hollow needle 616 via the proximal slot 616A thereof for selective distal advancement past the distal end of the needle via user actuation of the slide. Note that distal advancement of the slide 628 causes the slide to separate from the housing 612 while still being attached to the guidewire 622. Distal advancement of the guidewire 622 out the distal end of the needle 616 is stopped when the guidewire bend 622A engages the distal end 616B of the proximal slot 616A of the needle.


A catheter advancement assembly 640 is also shown for selectively advancing the catheter tube 44 over the needle 616, including a carriage 650 disposed within the housing 612 and operably connected to the slide 628 such that actuation of the slide distally advances both the guidewire 622 and the carriage 650. The carriage 650 is not initially engaged with the catheter hub 46, but engages the hub after an amount of distal advancement. This in turn causes the catheter 42 to be distally advanced toward the distal housing end.


The insertion tool 610 further includes a support structure 670 for stabilizing the needle 616, including a plug 672 that includes a plug hole 674 defined therein through which the needle 616 extends. The plug 672 is attached via the track 630 to the slide 628 and occludes the distal end of the housing 612, thus serving to stabilize the needle 616 that passes therethrough during needle insertion into the patient. Later, when the guidewire 622 is advanced distally by the slide 628, the plug 672 also distally advances out the housing 612, thus opening the housing distal end and enabling the catheter 42 to pass therethrough. The catheter 42 can then be separated by the user from the insertion tool 610 and advanced into final position by the user. Note that, in one embodiment, the carriage 650 can include a needle safety component for isolating the distal end of the needle 616.


Reference is now made to FIG. 31 in describing a catheter insertion tool 710 according to one embodiment. The insertion tool 710 includes a housing 712 that partially encloses the catheter 42. A hollow needle 716 distally extends from a needle hub 714 that caps a proximal end of the housing 712 such that the needle extends out the distal end of the housing 712.


An advancement assembly 720 is shown for selectively advancing a guidewire 722 and catheter 42. The advancement assembly 720 includes a wheel 730, selectively rotatable by a user, that is attached via a filament 726 or other suitable component to a carriage 750. The guidewire 722 is attached to the carriage 750 and extends proximally within the housing 712 and out through a pigtail 724, attached to the proximal end of the housing 712, via a one of two holes defined in the needle hub 514 (similar to the holes 514A in the needle hub 514 of FIGS. 29A, 29B). Near the proximal end of the pigtail 724, the guidewire 722 bends to form a U-shaped guidewire bend 722A and distally extends back into the housing 712 to pass into the hollow needle 716 via the other of the two holes defined in the needle hub 714 for eventual distal advancement out the distal end of the needle when the wheel 730 is selectively actuated by a user. Such distal advancement of the guidewire 722 out the distal end of the needle 716 is stopped when the guidewire bend 722A abuts the above-mentioned holes defined in the needle hub 714.


The advancement assembly 720 selectively advances the catheter tube 44 over the needle 716 and includes the aforementioned carriage 750 disposed within the housing 712 and operably connected to the wheel 730 via the filament 726 such that rotation of the wheel distally advances the carriage 750. The guidewire 722, a proximal end of which being attached to the carriage 750, is also advanced distally through the needle, as described above. Note that in one embodiment the wheel 730, by virtue of the non-rigid filament 726 connecting the wheel to the carriage 750, ensures that the guidewire 722 is only distally advanced, and not proximally retractable.


Distal advancement of the carriage 750 causes the carriage—which is not initially engaged with the catheter hub 46—to engage the hub after an amount of distal advancement. This in turn causes the catheter 42 to be distally advanced toward the distal housing end.


The insertion tool 710 further includes a support structure 770 for stabilizing the needle 716, including a door 772 hingedly attached to the distal end of the housing 712 and including a hole 774 therein for enabling passage of the needle 716 therethrough. The door 772 serves to stabilize the needle 716 during insertion into the patient. Later, when the catheter tube 44 and catheter hub 46 are advanced distally by the wheel 730 and the carriage 750, the door 772 is pushed open by the hub, enabling the catheter 42 to be separated by the user from the insertion tool 710. The catheter 42 can then be advanced for final placement within the patient by the user. Note that, though none is shown, a needle safety component can be included for isolating the distal tip of the needle 716.


Reference is now made to FIGS. 32A-32I in describing a catheter insertion tool 810 according to one embodiment. The insertion tool 810 includes a housing 812 that at least partially encloses the catheter 42. A hollow needle 816 distally extends from a needle hub 814 included within the housing 812 such that the needle initially extends out the distal end of the housing 812. The needle 816 includes a distal slot 816A, similar to the previously described needle slot 226 (FIGS. 17A-17C), for enabling a guidewire/dilator 822, similar to the previously described guidewire/dilator 220 (FIG. 16) to be removably inserted therein. The catheter 42 is disposed over the guidewire/dilator 822.


The needle hub 814 further includes a needle refraction system 818 for selectively retracting the needle 816 into the housing 812 so as to isolate the distal tip of the needle from the user in a safe manner. The retraction system 818 includes a spring 819 or other suitable retraction device operably coupled to the needle 816 for effecting the needle retraction.


An advancement assembly 820 is shown for selectively advancing the guidewire/dilator 822 as well as the catheter 42. The advancement assembly 820 includes a slide 828 that travels in a track 830 defined in the housing 812. The slide 828 is operably attached to a ratchet bar 824 slidably disposed within the housing 812. The ratchet bar 824 includes a plurality of upper teeth 826 for selective catheter advancement, and at least one lower tooth 826A for actuating a retraction trigger 880 of the needle retraction system 818, as will be described. The hub 46 of the catheter 42 disposed within the housing 812 has removably attached thereto a cap 834 including a prong 836 for engaging the upper teeth 826 of the ratchet bar 824.


The insertion tool 810 further includes a support structure 870 for stabilizing the needle 816, including a housing hole 872 defined by the distal end of the housing 812. The housing hole 872 is sized to provide stability to the needle 816 at its point of exit from the housing.



FIGS. 32A-32I depict various stages of use of the insertion tool 810 in inserting a catheter into a patient. With the insertion tool 810 in the configuration shown in FIG. 32A, vascular access is achieved with the needle 816 via user insertion of the needle into the patient at an insertion site. Blood flashback can be observed via the distal slot 816A of the needle 816 to confirm proper positioning of the distal end of the needle within the patient's vessel. As shown in FIG. 32B, the slide 828 is slid distally to advance the guidewire/dilator 822, a distal portion of which is pre-disposed within the needle 816 via the distal slot 816A, distally out the distal end of the needle and into the vessel of the patient. As shown, the guidewire/dilator 822 is advanced indirectly by the ratchet bar 824, which is moved by the slide 828. In particular, a proximate one of the upper teeth 826 of the ratchet bar 824 engages the prong 836 of the cap 834 fitted over the catheter hub 46. Thus, when the slide 828 and ratchet bar 824 are moved distally, the catheter 42 and guidewire/dilator 822 disposed therein are also moved distally, as shown in FIG. 32B. Similar ratcheting movement occurs in the successive steps as well.


Sliding of the slide 828 in the stage shown in FIG. 32B also causes the bottom tooth 826A of the ratchet bar 824 to engage the retraction trigger 880 of the needle retraction system 818. This in turn enables the spring 819 to expand and retract the needle 816 and retraction system 818 into the housing 812 such that the distal tip of the needle is isolated from the user within the housing.



FIG. 32C shows the return of the slide 828 to its initial position, which causes the ratchet bar 824 to also return to its initial position. Because the prong 836 of the cap 834 attached to the catheter hub 46 is distally angled, however, the teeth 826 of the ratchet bar slide past without retracting the catheter 42 such that the catheter remains in position.


In FIG. 32D, the slide 828 is again distally advanced, which causes a proximate upper tooth 826 of the ratchet bar 824 to engage the cap prong 836 and further advance the guidewire/dilator 822 distally into the vessel. As it is disposed over the guidewire/dilator 822, the catheter 42 at this or a successive stage is also advanced into the vessel, depending on catheter length, distance to insertion site, etc. The slide 828 is subsequently retracted to its initial position, as shown in FIG. 32E. Note that ratchet retraction can be user activated or automatically activated by a suitable system included in the insertion tool 810.


In FIG. 32F, the slide 828 and ratchet bar 824 are again distally advanced, resulting in further distal advancement out of the housing 812 of the guidewire/dilator 822 and catheter 42. The slide 828 is subsequently refracted to its initial position, as shown in FIG. 32G. In FIG. 32H, the slide 828 and ratchet bar 824 are distally advanced a final time, resulting in near-complete distal advancement of the guidewire/dilator 822 and attached catheter 42 from the housing 812 of the insertion tool 810. At this stage, the hub 46 of the catheter 42 can be grasped and the catheter removed from the insertion tool 810, which can then be discarded. Final positioning of the catheter 43 within the vessel can then be manually performed by the user. The cap 834 is also removed from the catheter hub 46.



FIGS. 33A-33C depict details of a needle safety component for isolating the distal end 16A of the needle 16, the needle including the distal notch 18 as discussed above in connection with FIGS. 1A-10C, according to one embodiment. As shown, a safety housing 954 including a hinged door is included so as to ride over the needle 16. Two needle safety components 956 are oppositely disposed within the safety housing 954 and each also rides over the needle 16. Each needle safety component includes a base 958 defining a hole through which the needle 16 passes and a plurality of arms 960. The arms 960 extend from the base 958 and converge toward one another in conical fashion such that an end of each arm abuts the needle surface. The arms 960 are configured to engage the notch 18 defined in the distal portion of the needle 16 and prevent further movement of the needle 16 with respect to the needle safety component 956. In particular, each arm 960 compressively engages the outer surface of the needle 16 such that when one of the arms encounters the needle notch 18, the arm will descend into the notch slightly so as to lock the needle 16 in place with respect to the needle safety component 956. Two needle safety components 956 are disposed in the safety housing 954 so as to prevent further needle movement in either direction, distally or proximally. Thus, the distal end 16A of the needle 16 is safely isolated within the safety housing 954, as seen in FIGS. 33A-33C. Note that the needle safety component described here is useful for isolating a needle even when the guidewire 22 still extends therethrough, as seen in FIG. 33C, for example.


In other embodiments, only one needle safety component as described above may be used. Thus, the needle safety component described here serves as one example of a variety of needle safety components that may be employed in connection with the present disclosure.


It is appreciated that in one embodiment the insertion tool can include a sterile sheath or bag that is disposed over a distal portion of the catheter that distally extends from the insertion tool housing so as to isolate the catheter. The needle, pre-disposed within the catheter and retractable into the insertion tool housing, can extend from the bag to gain vascular access. Thereafter, the bag can be compressed toward the housing as the catheter is advanced into the vasculature, then disposed of once the catheter is fully inserted. In one embodiment, the bag can include a grip wing or other device that helps to grasp the catheter or needle through the bag during insertion. Further note that the insertion tools described herein can include a cap or other protective device that is removably attached to the insertion tool before use so as to preserve the sterility of the needle and catheter.


Reference is now made to FIG. 34, which depicts an exploded view of the catheter insertion device 10 according to one embodiment, including components similar to those that have already been described above. As such, only selected differences are discussed below.



FIG. 34 shows that in the present embodiment the guidewire 22 is looped back on itself to substantially define a U-shaped configuration. FIGS. 36A and 36B shows the manner in which the guidewire 22 is disposed within the housing 12 of the catheter insertion device 10. In particular, these figures show that a proximal end of the guidewire 22 is anchored to a portion of the device 10, namely, at an anchor point 982 on the top portion 12A of the housing 12. FIG. 37 shows that the guidewire 22 extends proximally and removably within a guide channel 984 defined on an interior surface of the top housing portion 12A. FIGS. 36A and 36B show that an intermediate portion of the guidewire 22 loops back on itself proximate the proximal end of the device 10. Guide surfaces 980 (FIG. 35) disposed near the proximal end of the guidewire lever 24 constrain the flexible guidewire 22 into the looped, substantially U-shaped configuration. The looped-back intermediate portion of the guidewire 22 then extends toward the distal end of the device 10 along a channel 986, best seen in FIG. 38, defined on an interior surface of the bottom housing portion 12B of the housing 12 before it passes into the hollow needle 16. The free distal end of the guidewire 22 initially resides within the needle 16.


So disposed as described immediately above, the guidewire 22 is positioned for selective advancement by the guidewire advancement assembly 20 such that the free distal end thereof can distally extend from the open distal tip of the needle 16. This selective advancement of the guidewire 22 is achieved in the present embodiment via distal movement of the guidewire advancement slide 28 included on the device housing 12. Distal movement of the guidewire advancement slide 28 causes corresponding distal sliding movement of the guidewire lever 24. The guide surfaces 980 of the guidewire lever 24 push the bend of the guidewire 22 distally as the lever advances. Note that the guidewire 22 is sufficiently rigid so as to be advanced by the guidewire lever 24 without buckling. Also, the guide surfaces 980 and guidewire 22 are configured to enable retraction of the guidewire 22 back into the insertion tool housing 12 when the guidewire advancement slide 28 or other suitable mechanism is slid proximally.


This pushing movement of the slidable guidewire lever 24 causes the distal end of the guidewire 22 to extend distally from the open distal tip of the needle 16. Because of its anchored proximal end at anchor point 982 and its bent or looped U-shape configuration, the guidewire 22 is distally advanced at a rate of about twice the rate of sliding of the guidewire advancement slide 28 and about twice the rate of guidewire advancement in the device configuration of FIGS. 1A-9, which results in about twice the length of guidewire extension when compared with the length of movement of the guidewire advancement slide 28. This further desirably results in a relatively longer length of guidewire extension into the vein or other patient vessel so as to more suitably guide the catheter 42 into the patient's body. As such, the guidewire and advancement assembly described here operates as a type of “reverse pulley” system for distal guidewire advancement. Note that other looping configurations of the guidewire can be included with the device 10 in addition to those shown and described herein. Also, differing ratios of guidewire extension vs. advancement assembly movement are also possible in other embodiments.


Note that the looping conduit and guidewire advancement handle are only examples of structures that can suitably perform the desired functionality described herein. Indeed, other structures can be employed to accomplish the principles described in connection with the present embodiment. Also, though shown and described above to be attached to the catheter insertion device housing, the proximal end of the guidewire can be attached to other structures within/on the device, such as the needle hub 14, for instance. The majority length of the guidewire in one embodiment includes a metal alloy of nickel and titanium commonly referred to as nitinol, which is sufficiently rigid and can be disposed in the U-shaped configuration without retaining a memory of that position when the guidewire is advanced. Note that other suitable guidewire materials can also be employed.



FIGS. 39A and 39B depict various details regarding the binding element 80, described further above, of the needle safety component 56 for shielding the distal tip of the needle 16 once catheter insertion is complete. As shown, the binding element 80 (which is also referred to herein as a binding member) includes a front plate 992 defining a hole 992A, and a forked back plate 994. A protuberance 996 extends from one of the forks of the back plate 994. A horseshoe-shaped needle pass-through element 998 is also included in a spaced-apart arrangement from the front plate 992 and defines a hole 998A in coaxial alignment with the hole 992A of the front plate.


A friction element 1000, also referred to herein as a friction member, is also included with the binding element 80 in the present embodiment, namely, an annular elastomeric element, or O-ring 1002, as seen in FIGS. 40A and 40B. As shown, the O-ring 1002 is configured to wrap around both a portion of the needle 16 and the forked back plate 994. The protuberance 996 is employed to aid in maintaining the O-ring 1002 in place as shown in FIGS. 40A and 40B. With the O-ring 1002 so positioned, a relatively constant urging force is imparted by the O-ring to the binding element 80, for use in shielding the distal tip of the needle 16, as will be described further below. Note that the elastomeric element can take forms other than an O-ring while performing the same functionality. For instance, a rod or length of elastomeric material that is wrapped about a portion of the binding element and the needle could also be employed.



FIGS. 40C and 40D show the binding element 80 disposed in the carriage 1008, which is in turn disposed within the safety housing 54. As shown, the carriage 1008 defines two constraining surfaces 1010 against which corresponding portions of the front plate 992 of the binding element initially rest when the needle 16 initially extends through the carriage and the binding element. A retaining ring 1008A through which the needle 16 slidably passes enables engagement of the needle with the carriage 1008.


The binding element 80 is initially slidably disposed with the needle 16 in the state shown in 40A-40D (showing the binding element before it has shielded the distal tip of the needle) such that relative sliding movement between the needle and the binding element is permitted. Passage of the needle 16 through the hole 998A of the needle pass-through element 998 initially limits canting movement of the binding element 80.


The needle 16 also passes through the hole 992A of the front plate 992 such that the needle is straddled by the forks of the forked back plate 994. As mentioned, the O-ring 1002 is disposed about the needle 16 and the back plate 994 so as to provide a drag force when the carriage 1008 and binding element 80 (both housed within the safety housing 54 (FIG. 34) are slid distally along the length of the needle 16 during use of the device 10. The drag force provided by the O-ring 1002 during such distal sliding in turn imparts a rotational moment on the binding element 80 (by virtue of forces provided via the contact of the binding element with the O-ring) to urge the binding element to rotate in a clockwise motion, from the perspective of the drawing shown in FIG. 40C.


Such clockwise rotation of the binding element 80 is prevented by the needle pass-through feature 998 while the needle 16 extends through the binding element. Once the safety housing 54 containing the carriage 1008 and binding element 80 has been slid distally a sufficient distance such that the needle pass-through element 998 slides past and off the distal end of the needle 16, however, the binding element is no longer constrained and the drag force imparted by the O-ring 1002 causes the binding element to cant clockwise with respect to the needle, from the perspective of the drawing shown in FIG. 40C. This canting locks movement of the binding element 80 and, by extension, the carriage 1008, with respect to the needle 16, by virtue of physical binding between the outer surface of the needle 16 with the perimeter of the front plate hole 992A, which thus acts as a binding surface. With the distal tip of the needle 16 safely disposed within the locked carriage 1008, the user is thus protected from an accidental needle stick.


As mentioned above, the O-ring 1002 imparts a relatively constant urging force for canting the binding element 80, which keeps the binding element canted (after withdrawal of the needle distal tip into the carriage as described above) so as to more securely lock the carriage 1008 over the distal tip of the needle 16. This constant urging force is beneficial, for example, in instances when the needle 16 is pushed back and forth with respect to safety housing 54/carriage 1008 after it has been locked over the needle distal tip to ensure that the binding element does not return to an orientation in which the needle pass-through feature 998 can re-engage the needle 16 and unlock the needle safety component 56. Note that the O-ring 1002 can be employed with needles and binding elements larger or smaller than those shown and described herein.


The O-ring 1002 in the above embodiments is sufficiently compliant so as to stretch over the aforementioned structures while imparting the desired force, as explained above. In one embodiment, the O-ring 1002 material includes any one or more of natural or synthetic rubber, elastomers, polymers, thermoplastics, silicones, etc. In one embodiment, the O-ring material is selected so as to provide sufficient tear resistance, ability to impart the desired friction, and chemical compatibility. The size of the O-ring can vary according to the size and configuration of the binding element and needle. In other embodiments, the O-ring can include other shapes, materials, and positional placements while still providing the intended functionality.



FIG. 41A shows that the guidewire lever 24 can include a catheter advancement feature that enables the guidewire lever to distally advance the catheter 42 in addition to advancing the guidewire 22 as described above. In the present embodiment, the catheter advancement feature includes an advancement tab 1014 disposed on the proximal portion 24A of the guidewire lever 24 and disposed so as to physically engage the cap 58 of the safety housing 54 when the guidewire lever 24 is moved distally via distal sliding by the user of the slide 28 (FIG. 34). Such engagement is shown in FIG. 41B. Further distal movement of the guidewire lever 24 results in distal advancement of the safety can 54 and the catheter 42 indirectly but operably attached thereto (FIG. 34). The slide 28 in the present embodiment can be slid to distally advance the catheter 42 a predetermined distance via the advancement tab 1014 of the guidewire lever 24. In one embodiment, the predetermined distance advances the catheter 42 until its distal end distally advances over the distal tip of the needle 16. Further distal advancement of the catheter 42 can be achieved via distal sliding of the handle 48 as needed (FIG. 34). In another embodiment, the slide 28 is configured to distally advance the catheter the full distal distance needed, via the advancement tab 1014.


The position of the advancement tab 1014 of FIG. 41A is such so as to provide staged advancement of the guidewire 22 and catheter 42. In particular, distal advancement of the guidewire lever 24 from the position shown in FIG. 41A produces immediate advancement of the guidewire 22 while the safety housing 54 and catheter 42 remain in place. Further distal advancement of the guidewire lever 24 to the position shown in FIG. 41B causes the advancement tab 1014 to engage and distally advance the safety can 54 and catheter 42, as described above, while continuing to distally advance the guidewire 22.


Thus, in addition to distally advancing the guidewire 22 out through the needle 16, the guidewire lever 24 can also advance the catheter 42 distally along the needle 16 and into a vessel of the patient, as described further above. Note that the particular shape and configuration of the advancement tab 1014, together with its manner of engagement with, and magnitude of travel imparted to, the safety housing and/or catheter can vary from what is shown and described herein.



FIGS. 42 and 43 depict details of the guidewire 22 configured in accordance with one embodiment. As shown in FIG. 42, the guidewire 22 includes an elongate core wire 1102 that includes a reduced-diameter distal portion 1104. An outer coil 1108 extends about the core wire 1102 proximally from the distal end 1102B thereof. A stiffening sleeve 1110 is disposed about the core wire 1102 proximal and adjacent to the coil 1108 within the reduced-diameter distal portion 1104. The stiffening sleeve 1110 can be glued, welded, press-fit, or otherwise secured to the core wire 1102.


The portion of the guidewire 22 on which the coil 1108 is included is designed so as to be relatively flexible so as to non-traumatically enter a vein or other vessel of a patient and to guide the catheter 42 into the vein during catheter insertion using the insert tool described herein. In contrast, the portion of the guidewire 22 on which the stiffening sleeve 1110 is included is relatively rigid. As seen in FIG. 43, the stiffening sleeve 1110 is positioned so that it is disposed adjacent the distal tip 16B of the needle 16 of the insertion tool upon full extension of the guidewire 22 during insertion tool use. Together with the back-cut bevel of the needle distal tip 16B, the stiffening sleeve 1110 effectively blunts the needle distal tip, thus preventing inadvertent piercing or shearing of the catheter tube 44 by the needle distal tip during catheter insertion into the vein. The stiffening sleeve 1110 can be sized so as to substantially occupy the whole of the diameter of the needle lumen at the distal tip 16B so that it effectively prevents the needle distal tip from being able to pierce the catheter tube 44, even if the catheter tube is retracted while disposed over the needle, or if the needle is re-inserted into the catheter tube. Note that, in another embodiment, the core wire itself can be used to blunt the needle distal tip. In one embodiment, the coil 1108 can include platinum, stainless steel, titanium, nitinol, or other material having suitable tensile strength and formability. In one embodiment, the stiffening sleeve 1110 includes stainless steel, titanium, high-rigidity thermoplastic, or other suitable material, and the core wire 1102 includes nitinol, though other suitable materials may be used for these and other related components.



FIG. 42 further shows that the core wire 1102 of the guidewire 22 can include a notch 1112 disposed proximal to the distal portion 1104 of the core wire. The notch 1112 serves as a relative weak point for preferential breaking of the guidewire 22 at the notch should the guidewire be subjected to excessive physical forces. By breaking at the notch 1112, the broken-off distal segment of the guidewire is large enough as to not be embolized into the vessel of the patient and can be readily removed manually from the body. The particular location of the notch on the guidewire can vary.



FIG. 44 shows that, in one embodiment, the distal end of the catheter tube 44 of the catheter 42 of the insertion tool can include a reinforcement component 1118 disposed substantially at the distal end 44A of the catheter tube. As shown in FIG. 44, the reinforcement component 1118 here includes an annular sleeve that defines the distal end 44A of the catheter tube 44. Including a sufficiently rigid material, such as aromatic polyurethane, carbothane, isoplast, pebax, nylon, or other suitable medical grade thermoplastic, metals including stainless steel, titanium, nitinol, etc., the reinforcement component 1118 is positioned and designed to prevent collapse of the distal end 44A of the catheter tube 44 during fluid aspiration through a lumen 1114 of the catheter tube after the catheter 42 has been placed within the patient vasculature. In one embodiment, the reinforcement component 1118 includes a material that is non-softening at internal body temperature, includes a similar melt temperature to that of the material of the catheter tube 44, and is biocompatible. In one embodiment, the reinforcement component 1118 includes a material having a hardness between about 60D and about 75D Shore hardness, though other hardness ratings are possible. In another embodiment, the reinforcement component 1118 can include a radiopacifier, such as bismuth trioxide, barium sulfate, etc., to enhance radiopacity of the distal end 44A of the catheter tube 44.



FIGS. 45A and 45B depict details regarding the manufacture of the catheter tube 44 of FIG. 44, according to one embodiment, though other techniques can be employed. As shown, during manufacture a shaped mandrel 1120 is disposed within the lumen 1114 of the catheter tube 44. The pre-formed, annular reinforcement component 1118 is disposed about a tip portion 1122 of the mandrel 1120 as to be interposed between the mandrel and the catheter tube 44 and substantially co-terminal with the distal end 44A thereof, in the present embodiment. In other embodiments, the reinforcement component 1118 can also positioned so as to produce a finished reinforcement component position that terminates proximal to the distal end 44A of the catheter tube 44, co-terminal therewith, or distal thereto, so as to customize a desired reinforcement profile, or to accommodate processing parameters, etc.


A tipping die 1124 is then paced over the distal end of the catheter tube 44, and a radio frequency (“RF”) tipping process is carried out so as to form the distal end of the catheter tube with the reinforcement component 1118 included therein, as shown n FIG. 44. A plug 1126 of excess material is often created as a result of the tipping process, and can be discarded. In addition to this, other processes can be employed to form the reinforcement structure with the distal end of the catheter tube.


Other embodiments of reinforcement structures for the distal end 44A of the catheter tube 44 are possible, such as the reinforcement components 1118 shown in FIGS. 46 and 47A, for example. FIG. 47B shows another embodiment, wherein the reinforcement component 1118 is set back proximal to the distal end of the catheter tube 44, thus illustrating that the reinforcement component need not be disposed at the distal end of the catheter tube in one embodiment. As such, these and other reinforcement designs are therefore contemplated.



FIGS. 48A-48F depict various details of the insertion tool 10 according to another embodiment. As shown in FIG. 48A, the insertion tool 10 includes the top and bottom housing portions 12A, 12B of the housing 12, from which extends the catheter 42 disposed over the needle 16. Also shown is a finger pad 1218 of the guidewire advancement assembly 20 slidably disposed in a slot 1236 defined in the top housing portion 12A, and a portion of a handle assembly 1220 of the catheter advancement assembly 40. Further details are given below of the present insertion tool 10 and its various details in accordance with the present embodiment.



FIGS. 48A-48F show that the finger pad 1218 as part of the guidewire advancement assembly 20 can be slid by a finger(s) of the user distally along the slot 1236 in order to enable selective advancement of the guidewire 22 (initially disposed within the lumen of the needle 16) out past the distal end 16B of the needle 16. As before, a proximal end of the guidewire 22 is attached to an interior portion of the top housing portion 12A such that a single unit of distal sliding advancement of the finger pad 1218 results in two units of distal guidewire advancement. This, as before, is made possible by looping the guidewire 22 from its attachment point on the top housing portion 12A and through the guide surfaces 980 included on the guidewire lever 24 (FIGS. 53A and 53B) before extending into the lumen of the needle 16. Note that in the present embodiment the guidewire lever 24 and finger pad 1218 of the guidewire advancement assembly 20 are integrally formed with one another, though they may be separately formed in other embodiments. Note also that the guidewire 22 can be attached to other external or internal portions of the insertion tool 10, including the bottom housing portion 12B, the needle hub 1214, etc.



FIGS. 48A-48F further show that the catheter advancement assembly 40 for selectively advancing the catheter 42 in a distal direction out from the housing 12 of the insertion tool 10 includes a handle assembly 1220, which in turn includes among other components two wings 1280 that are grasped by the fingers of the user when the catheter is to be advanced. As will discussed in further detail below, the wings 1280 distally advanced via the gap 1250 defined between the top and bottom housing portions 12A, 12B.


The top and bottom housing portions 12A, 12B are mated together via the engagement of four tabs 1230 (FIGS. 48D, 49) of the top housing portion with four corresponding recesses 1232 located on the bottom housing portion. Of course, other mating mechanisms and schemes can be employed for joining the top and bottom housing portions together.


The exploded view of the insertion tool 10 in FIG. 49 shows that the handle assembly 1220 includes a head portion 1222 from which extend the wings 1280, and a tail portion 1224. Both the head portion 1222 and the tail portion 1224 are removably attached to the catheter hub 46, as will be discussed further below. Internal components of the insertion tool 10 that are disposed within the housing 12, each of which is passed through by the needle 16 include valve 52, the safety housing 54 in which the carriage 1008 and the needle safety component 56 is disposed, and the cap 58 of the safety housing. The O-ring 1002 that is included with the needle safety component 56 is also shown, as is a needle hub 1214, which is secured to a proximal end of the needle 16 and is mounted to the housing 12 to secure the needle 16 in place within the insertion tool 10. Note in FIG. 49 that, in one embodiment, the slot 1236 in which the finger pad of the guidewire advancement assembly 20 is disposed includes a relatively wide portion to enable the guidewire lever 24 to be inserted therethrough in order to couple the guidewire advancement assembly to the housing 12.



FIGS. 50A and 50B depict various details regarding the stability structure 70 for supporting and stabilizing the needle 16 at its exit point from the housing 12, according to the present embodiment. As shown, proximal portions of the top and bottom housing 12A, 12B inter-engage to provide the stability structure 70 for the needle 16. The bottom housing portion 12B includes two distally-disposed arms 1248 separated by a slot 1246 that enables the arms, when unconstrained, to separate from one another. The top housing portion 12A defines a distal slot 1240 and a horseshoe feature 1242 distal to the slot. Given the downward curvature of the top housing portion 12A (see FIG. 48C), the slot 1240 enables the arms 1248 of the bottom housing portion 12B to protrude upward through the slot to surround and support the needle 16 in order to stabilize it. The horseshoe feature 1242 is disposed about the needle 16 at the distal end of the bottom housing arms 1248 and acts as a collar to stabilize the needle.


The arms 1248 of the bottom housing portion 12B are configured to be able to move back and forth in the x-direction, according to the x-y axis shown in FIGS. 50A and 50B, while remaining substantially rigid in the y-direction. Conversely, the distal portion of the top housing portion 12A that includes the slot 1240 and the horseshoe feature 1242 is configured so as to flex in the y-direction according to the x-y axis shown in FIGS. 50A and 50B, while remaining substantially rigid in the x-direction. Thus, when overlapped or inter-engaged as shown in FIGS. 50A and 50B, the above-referenced components of the stability structure 70 cooperate to support the needle 16 and prevent its substantial movement when the housing 12 is in the configuration shown in FIGS. 50A, 50B, that is, before removal of the catheter 42 from the housing 12. This in turn assists the user in accurately piercing the skin and accessing a vessel of the patient. It is appreciated that the stability structure can include other components to stabilize the needle in addition to those explicitly described herein.



FIGS. 51-54 depict various details regarding the catheter advancement assembly 40 and the guidewire advancement assembly 20, according to the present embodiment. As discussed, the catheter advancement assembly 40 includes the handle assembly 1220, which in turn includes the head portion 1222 with the corresponding wings 1280, and the tail portion 1224 disposed about a portion of the catheter hub 46 and the safety housing 54. As will be discussed further below, the handle assembly 1220 is employed in distally advancing and removing the catheter 42 from the insertion tool 10.



FIGS. 51-54 further show the finger pad 1218 and the guidewire lever 24 of the guidewire advancement assembly 20 for the present embodiment. As shown, the guidewire lever 24 extends proximally from the finger pad 1218 and includes on its proximal end the previously discussed guide surfaces 980 for guiding the looping of the guidewire 22. An actuation block 1258 is also included near the proximal end of the guidewire lever 24 for use in enabling catheter advancement, as will be described further below. Note that the particular size, shape, and other configuration of the actuation block can vary from what is shown and described herein while retaining the desired functionality.


A spring arm 1260 extends downward from the guidewire lever 24 and is configured to be slidably retained between two guide posts 1264 of the needle hub 1214, as best seen in FIGS. 53A and 53B. The spring arm 1260 is employed for locking further movement of the guidewire advancement assembly 20 once the guidewire 22 has been fully distally extended from the insertion tool 10 and the catheter 43 advanced an incremental amount. In particular, distal sliding by the user of the finger pad 1218 causes the guidewire lever 24 to also distally move, which in turn distally advances the guidewire 22 (which internally loops past the guide surfaces 980 of the guidewire lever 24 and into the needle lumen) through the lumen of the needle 16 and past the needle distal end 16B, as seen in FIG. 54.


Upon full distal advancement of the finger pad 1218 and guidewire lever 24 as seen in FIG. 54, the free end of the spring arm 1260 is disposed just above a pocket 1266 defined between the guide posts 1264 of the needle hub 1214, as seen in FIG. 53B. Because of the location of the safety housing 54 proximal and adjacent to the needle hub 1214 at this stage (the catheter 42—and also the attached safety housing—in its initial seated position due to it having not yet been distally advanced via distal advancement of the catheter advancement assembly 40 as described further below), the free end of the spring arm 1260 cannot yet seat in the pocket 1266. Once the catheter 42 is advanced an incremental distance distally, however, the attached safety housing 54 no longer impedes downward movement of the spring arm 1260 and the free end thereof seats into the pocket 1266 of the needle hub 1214. Further distal movement of the guidewire advancement assembly 20 is prevented by impingement of the finger pad 1218 on the distal end of the slot 1236, while proximal movement is prevented by the seating of the spring arm in the pocket 1266 of the needle hub.


Note that the finger pad 1218 includes on its underside proximate its distal end a protrusion 1254 that engages with a depression 1252 defined on the top housing portion 12A when the finger pad is completely distally advanced. This assists in keeping the finger pad 1218 seated in its distal position and provides a tactile cue that the finger pad has been fully distally advanced.


Note also that, should the catheter advancement assembly 40 be moved proximally back to its initial position (as seen in FIG. 52), the safety housing 54 will once again abut against the needle hub 1214 and push the free end of the spring arm 1260 up and out of the pocket 1266. This in turn enables the guidewire advancement assembly 20 to again move proximally and distally, causing corresponding proximal and distal advancement of the guidewire 22 itself. Thus, locking of the guidewire advancement is reversible, in the present embodiment.


In another embodiment it is appreciated that a push button can be included with the guidewire advancement assembly 20 to enable the guidewire to be extended or retracted anew after locking of the guidewire has initially occurred, such as via depressing of the button to disengage the spring arm 1260 from the pocket 1266 of the needle hub, for instance. These and other variations are therefore contemplated.



FIGS. 55-56C show that, in accordance with the present embodiment, the insertion tool 10 as presently described further includes locking of catheter movement prior to the distal advancement of the guidewire 22 as described above. In detail, FIGS. 55 and 56A shows the guidewire advancement assembly 20 and the tail portion 1224 of the handle assembly 1220 of the catheter advancement assembly 40 in their initial positions within the insertion tool housing 12, that is, prior to distal guidewire advancement and catheter distal advancement. In this position, two spring arms 1272 of the tail portion 1224 are positioned such that both guide posts 1264 of the needle hub 1214 are seated within respective notches 1274 of the spring arms, best seen in FIG. 56A. In this position, the tail portion 1224 is prevented from movement. Given the attachment of the tail portion 1224 to the hub 46 of the catheter 42, this also prevents distal advancement of the catheter or any other portion of the catheter advancement assembly 40.


As seen in FIGS. 56A and 56B, distal advancement of the guidewire lever 24 causes its actuation block 1258 to engage slanted surfaces 1276 of each spring arm 1272. As best seen in FIG. 56B, continued distal movement of the guidewire lever 24 causes the actuation block 1258 to spread open the spring arms 1272, which disengages the guide posts 1264 from spring arm notches 1274. The actuation block 1258 impacts the guide posts 1264, as seen in FIG. 56B, at the point of full distal advancement of the guidewire 22 and the positioning of the free end of the spring arm 1260 of the guidewire lever 24 just above the pocket 1266 of the needle hub 1214, as was described above in connection with FIGS. 52-54. At this point, the spring arms 1272 of the tail portion 1224 are disengaged from the guide posts 1264 of the needle hub 1214, and distal catheter advancement is thus enabled, as shown by the distal movement of the spring arms in FIG. 56C. Also, and as was described above in connection with FIGS. 52-54, this distal catheter advancement correspondingly distally moves the safety housing 54, which is attached to the catheter 42. Movement of the safety housing causes the free end of the spring arm 1260 of the distally advanced guidewire lever 24 fall into the pocket 1266 of the needle hub 1214, locking further movement of the guidewire 22 barring return of the safety housing to its initial position adjacent the needle hub.


Thus, it is seen that the configuration of the insertion tool 10 of the present embodiment prevents distal movement of the catheter 42 until full distal extension of the guidewire 22 has occurred. Also, further movement of the guidewire 22 is prevented while the catheter 42 has been distally advanced at least incrementally from its original proximal position. In another embodiment, an incremental amount of guidewire distal advancement could enable catheter advancement.


In yet another embodiment, locking of guidewire movement is made permanent after full distal advancement. This could be achieved, in one embodiment, by configuring the spring arm 1260 of the guidewire lever 24 and the pocket 1266 of the needle hub 1214 to not interact with the safety housing 54; as such, once the free end of the spring arm 1260 seats within the needle hub pocket 1266, it remains seated permanently. In another embodiment, locking of catheter movement is made after full distal catheter advancement. In still another embodiment, guidewire and/or catheter advancement can be achieved via a ratcheting mechanism.


In another embodiment, the ability to advance the catheter is unrelated to guidewire advancement. In yet another embodiment, the spring arm 1260 of the guidewire lever 24 can be removed such that no locking of the guidewire advancement assembly 20 occurs. In turn, this enables locking of catheter advancement until full distal guidewire advancement has occurred. These and other variations are therefore contemplated.



FIGS. 57A and 57B depict various details regarding the distal advancement of the catheter 42 from the insertion tool 10. As shown, once the guidewire advancement assembly 20 has distally advanced the guidewire 22 such that it extends past the distal end 16B of the needle 16, the catheter advancement assembly 40 is free (as described above in connection with FIGS. 55-56C) to be employed in distally advancing the catheter 42 out the distal end of the insertion tool housing 12. The catheter 42 is advanced by a user grasping one or both of the wings 1280 of the head portion 1222 of the handle assembly 1220 and moving the wings distally. Note that ridges 1282 (FIG. 50B) are included to assist the user in gripping the wings 1280. The wings 1280 slide distally in the gap 1250 defined between the top and bottom housing portions. Given the attachment of the wings 1280 to the head portion 1222, which in turn is attached to the hub 46 of the catheter 42, distal sliding of the wings distally advances the catheter.



FIGS. 57A and 57B show that, as the catheter 42 is distally advanced, the distal movement of the wings 1280 causes the wings to impinge on and push upwards the top housing portion 12A, which in turn lifts the distal portion of the top housing portion, including the slot 1240 and the horseshoe feature 1242 of the stability structure 70. Lifting of the slot 1240 causes the arms 1248 of the bottom housing portion 12B to disengage from the slot, thus enabling them to spread apart. FIGS. 57A and 57B show that two posts 1286 disposed on the head portion 1222 of the handle assembly 1220 (see also FIG. 60) push against each of the arms 1248 as the catheter distally advances, which causes the arms to separate. This separation of the arms 1248, together with the lifting by the wings 1280 of the top housing portion, enables the catheter 42 to pass through the distal end of the housing 12.



FIGS. 58 and 59 show removal of the catheter 42 and catheter advancement assembly 40 from the insertion tool housing 12, wherein continued distal advancement of the head portion 1222 via the user grasping and advancing the wings 1280 causes the catheter 42, the handle assembly 1220 (including the head portion 1222 and the tail portion 1224), and the safety housing 54 removably attached to the catheter hub 46 to slide distally along the needle 16 and out of the housing 12. This action is performed, for instance, to advance the catheter tube 44 into the vessel of the patient after the needle 16 and the guidewire 22 have cooperated to provide a pathway into the vessel.



FIG. 59 shows that further separation of the catheter 42 and handle assembly 1220 from the housing 12 causes the safety housing 54 to arrive at the distal end 16B of the needle 16, at which point the needle safety component 56 disposed in the safety housing (FIG. 49) engages the needle distal tip to prevent accidental needle sticks for the user, and the safety housing laterally detaches from the catheter hub 46 and remains with the needle.



FIG. 60 shows various features of the handle assembly 1220, which includes the head portion 1222 and the tail portion 1224. After the above separation of the safety housing 54 and needle 16 from the catheter 42 and handle assembly 1220, the head portion 1222 and the tail portion 1224 remain attached to the needle hub 46 and its corresponding strain relief 47 via clip arms 1300 and 1304, respectively. At this point, the head portion 1222 can be removed from the catheter hub 46/strain relief 47 by the hand of the user to overcome the friction fit of the clip arms 1300. The tail portion 1224, which includes a loop 1306 disposed about the valve 52, can also be removed via pulling and twisting by the user to overcome the friction fit of the clip arms 1304 and avoid the threads of the catheter hub 46. This action will remove the valve 52 (see FIG. 49), which is attached to the tail portion 1224. In another embodiment, the tail portion loop 1306 is configured so that the valve 52 is exposed after removal of the tail portion 1224 so as to enable removal of the valve by the user when desired. Once the head portion 1222 and the tail portion 1224 of the handle assembly 1220 have been removed from the catheter 42, the catheter can be dressed and used as desired.


The handle assembly 1220 can be configured in other ways, in addition to what has been described above. FIGS. 61 and 62 give one example of the handle assembly 1220, wherein the head portion and the tail portion are unified in a singular body 1312. As shown in FIG. 62, this enables the safety housing 54 to be removed laterally from the handle assembly 1220, after which the catheter hub 46 can be removed vertically therefrom. FIG. 63 includes a similar configuration for the handle assembly 1220, wherein the valve 52 includes oppositely-disposed extensions 1316, which enables the extensions to be gripped (after lateral removal of the safety housing 54) and the handle assembly 1220 is removed vertically. These actions leave the valve 52 and its extensions 1316 attached to the hub 46 of the catheter 42, at which point the valve can be removed from the hub laterally, using the extensions if desired.


In FIG. 64, the handle assembly 1220 includes a singular body that defines a living hinge 1320 disposed just distal to the loop 1306, though other locations for the living hinge are possible. Note that the loop 1306 captures the valve 52. In one embodiment, the valve 52 is integrally formed with or attached to the handle assembly body. In another embodiment, the valve 52 is separate from the handle assembly 1220 and is not affected by removal of the handle assembly 1220. The handle assembly 1220 further includes the clip arms 1304 that removably attach to the catheter hub 46 to secure the catheter 42 in place. Posts 1286 are also included on the handle assembly 1220, as in previous embodiments.


As FIG. 65 shows, the wings 1280 can be grasped to arcuately pull the distal portion of the handle assembly 1220 proximally, which then disengages the clip arms 1304 and posts 1286 from the catheter hub 46 and enables the handle assembly and valve 52 to be pulled from the catheter hub laterally. These and other handle assembly configurations are therefore contemplated.



FIGS. 66A-66C depict details of an insertion tool including a catheter advancement configuration according to one embodiment, wherein an insertion tool housing 1340 includes a catheter advancement lever 1344 that engages with a guidewire advance button such that the catheter advancement lever is initially maintained in a depressed position underneath the guidewire advance button, preventing catheter advancement. Once the guidewire advance button 1348 is moved distally, the catheter advancement lever 1344 pops upward, which unlocks catheter advancement and enables the catheter tube 44 to be distally advanced, such as by distal movement of the catheter advancement lever. It is appreciated that one or more of a variety of internal mechanisms can be included in the housing 1340 to facilitate the functionality described here.


Note that the insertion tool 10 as described immediately above is configured so that it can be grasped by a hand of the user and employed in deploying the catheter into the patient without the need for the user to move the hand grasping the device. In particular, the finger pad 1218 of the guidewire advancement assembly 20 and the wings 1280 of the catheter advancement assembly 40 are positioned distal relative to the location where the user grasps the housing 12 in order to use the insertion tool 10, thus eliminating the need for the user to move the grasping hand during advancement of the finger pad or wings.


In one embodiment, the user grasps the insertion tool housing 12 with one hand and uses the other hand to advance at least one of the finger pad 1218 and the wings 1280, again without moving the hand grasping the insertion tool housing. In another embodiment, the user can use the fingers of the hand grasping the insertion tool housing to advance one or both of the finger pad 1218 and the wings 1280.


Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the embodiments is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims
  • 1. An insertion tool for inserting a catheter into a body of a patient, comprising: a housing in which at least a portion of the catheter is initially disposed;a needle distally extending from the housing, at least a portion of the catheter pre-disposed over the needle;a guidewire;a guidewire advancement assembly for selectively distally advancing a distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter; anda catheter advancement assembly for selectively advancing the catheter in a distal direction, the catheter advancement assembly including a proximal portion in locking engagement in the housing when the guidewire advancement assembly is in a guidewire retracted position, the guidewire advancement assembly including an actuation member designed to disengage the proximal portion in a guidewire advanced position.
  • 2. The insertion tool as defined in claim 1, wherein the guidewire advancement assembly includes a locking member to prevent proximal retraction of the guidewire after the catheter advancement assembly has been distally advanced from a catheter retracted position.
  • 3. The insertion tool as defined in claim 2, wherein the locking member is a spring arm that is configured to engage with a pocket within the housing to prevent proximal retraction of the guidewire.
  • 4. The insertion tool as defined in claim 3, wherein the spring arm is disposed on a guidewire lever, the guidewire lever attached to a finger pad slidably disposed on the housing, and wherein the pocket is included in a needle hub within the housing, a proximal end of the needle mounted to the needle hub.
  • 5. The insertion tool as defined in claim 4, wherein the catheter advancement assembly includes a safety housing, a needle safety component disposed within the safety housing, the safety housing initially disposed at an initial position adjacent the needle hub, and wherein distal movement of the safety housing via the catheter advancement assembly enables a free end of the spring arm to seat in the pocket of the needle hub after full distal advancement of the guidewire is performed.
  • 6. The insertion tool as defined in claim 5, wherein the catheter advancement assembly is configured such that proximal movement of the safety housing to the initial position adjacent the needle hub pushes the free end of the spring arm out of the pocket of the needle hub to once again enable guidewire advancement and retraction.
  • 7. The insertion tool as defined in claim 4, wherein the guidewire lever includes the actuation member.
  • 8. The insertion tool as defined in claim 7, wherein the proximal portion of the catheter advancement assembly is in locking engagement with the needle hub in the guidewire retracted position, the actuation member on the guidewire lever disengaging the proximal portion from the needle hub in the guidewire advanced position.
  • 9. An insertion tool for inserting a catheter into a body of a patient, comprising: a housing in which at least a portion of the catheter is initially disposed, the housing including: a top housing portion;a bottom housing portion; anda stability structure having a top portion included with the top housing portion and a bottom portion included with the bottom housing portion, wherein: the bottom portion of the stability structure is configured to be substantially flexible in a first direction and substantially rigid in a second direction, andthe top portion of the stability structure is configured to be substantially flexible in the second direction and substantially rigid in the first direction;a needle distally extending from the housing, at least a portion of the catheter pre-disposed over the needle, the stability structure disposed at an exit point of the needle from the housing, the stability structure configured to support the needle extending from the housing and to separate upon distal advancement of the catheter to enable the catheter to exit the housing;a guidewire; anda guidewire advancement assembly for selectively advancing a distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter.
  • 10. The insertion tool as defined in claim 9, wherein the top portion and the bottom portion of the stability structure are configured to overlap one another so as to provide support to the needle.
  • 11. The insertion tool as defined in claim 10, wherein the bottom portion of the stability structure includes a first arm laterally spreadable from a second arm to enable the catheter to pass.
  • 12. The insertion tool as defined in claim 11, wherein the top portion of the stability structure is included on a distal portion of the top housing portion, the top portion of the stability structure being vertically flexible and including a slot defined in the distal portion of the top housing portion, the first arm and the second arm of the bottom portion of the stability structure extending partially through the slot before distal advancement of the catheter.
  • 13. The insertion tool as defined in claim 12, wherein the top portion of the stability structure includes a horseshoe feature that is disposed adjacent the slot and partially about the needle.
  • 14. The insertion tool as defined in claim 13, further comprising a catheter advancement assembly coupled to the catheter, wherein distal advancement of the catheter advancement assembly moves the first arm and the second arm of the bottom portion of the stability structure out of the slot of the top portion of the stability structure and separates the first arm from the second arm.
  • 15. The insertion tool as defined in claim 9, wherein the guidewire includes a rigid portion that is disposed adjacent a distal end of the needle upon full distal advancement of the guidewire, the rigid portion configured to prevent piercing of the catheter by the distal end of the needle.
  • 16. The insertion tool as defined in claim 15, wherein the rigid portion includes a sleeve that is included on the guidewire.
  • 17. The insertion tool as defined in claim 9, wherein the guidewire includes a notch, the notch configured to provide a preferential break point for the guidewire, a portion of the guidewire that is distal to the notch including a length that is sufficient to safely remove the guidewire from the patient.
  • 18. The insertion tool as defined in claim 9, wherein a distal portion of the catheter includes a reinforcement structure configured to prevent collapse of the distal portion of the catheter during aspiration of fluids through the catheter.
  • 19. The insertion tool as defined in claim 18, wherein the reinforcement structure includes an annular sleeve that is included in a wall of the catheter.
  • 20. An insertion tool for inserting a catheter into a body of a patient, comprising: a housing in which at least a portion of the catheter is initially disposed;a needle distally extending from the housing, at least a portion of the catheter pre-disposed over the needle;a guidewire;a guidewire advancement assembly for selectively distally advancing a distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter; anda catheter advancement assembly for selectively advancing the catheter in a distal direction, the catheter advancement assembly including a handle assembly, the handle assembly including a proximal portion in locking engagement in the housing when the guidewire advancement assembly is in a guidewire retracted position, the guidewire advancement assembly including an actuation member designed to disengage the proximal portion in a guidewire advanced position.
  • 21. The insertion tool as defined in claim 20, wherein the handle assembly includes a head portion and a tail portion, the head portion and the tail portion removably attached to the catheter, the tail portion including the proximal portion.
  • 22. The insertion tool as defined in claim 20, wherein the catheter includes a catheter hub, the handle assembly removably attached to the catheter hub, wherein a valve is removably included in the catheter hub, wherein a safety housing is removably disposed in the valve, the safety housing configured to be removed in a lateral direction, and wherein the handle assembly and catheter hub are configured to separate from one another in a vertical direction.
  • 23. The insertion tool as defined in claim 22, wherein the valve includes at least one laterally extending rib to assist in removal of the valve from the catheter hub.
  • 24. The insertion tool as defined in claim 20, wherein the catheter includes a catheter hub, the handle assembly removably attached to the catheter hub, the handle assembly including a living hinge configured to enable the handle assembly to be selectively removed from the catheter hub.
  • 25. The insertion tool as defined in claim 24, wherein the handle assembly includes a valve that is removably disposed in the catheter hub.
  • 26. The insertion tool as defined in claim 20, wherein the handle assembly includes first and second wings, the wings including ridges to assist with user grasping of the wings.
  • 27. An insertion tool for inserting a catheter into a body of a patient, comprising: a housing in which at least a portion of the catheter is initially disposed, the housing including: a top housing portion;a bottom housing portion; anda stability structure comprising: a top portion included on a distal portion of the top housing portion, the top portion being vertically flexible and including a slot defined in the distal portion of the top housing portion; anda bottom portion included with the bottom housing portion, the bottom portion configured to overlap the top portion, the bottom portion including a first arm spreadable from a second arm to enable the catheter to pass, the first arm and the second arm extending partially through the slot prior to distal advancement of the catheter;a needle distally extending from the housing, at least a portion of the catheter pre-disposed over the needle, the stability structure disposed at an exit point of the needle from the housing, the stability structure configured to support the needle extending from the housing and to separate upon distal advancement of the catheter to enable the catheter to exit the housing;a guidewire; anda guidewire advancement assembly for selectively advancing a distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent application Ser. No. 14/099,050, filed Dec. 6, 2013, and titled “Guidewire Extension System for a Catheter Placement Device, which claims the benefit of U.S. Provisional Patent Application No. 61/771,703, filed Mar. 1, 2013, and titled “Needle Safety and Guidewire Extension Systems for a Catheter Insertion Device,” and which is a continuation-in-part of U.S. patent application Ser. No. 13/107,781, filed May 13, 2011, now U.S. Pat. No. 8,932,258, and titled “Catheter Placement Device and Method,” which claims the benefit of the following U.S. Provisional Patent Application Nos. 61/345,005, filed May 14, 2010, and titled “Catheter Insertion System Including an Integrated Guidewire Dilator;” 61/345,022, filed May 14, 2010, and titled “Systems and Methods for Placement of an Intermediate Dwell Catheter Including a Needle Blunting System;” 61/372,050, filed Aug. 9, 2010, and titled “Catheter Insertion Tool Including Fold-out Guidewire Advancement Flaps;” and 61/385,844, filed Sep. 23, 2010, and titled “Catheter Insertion Tool Including Guidewire Advancement.” This application also claims the benefit of U.S. Provisional Patent Application No. 61/988,114, filed May 2, 2014, and titled “Catheter Placement Device Including Catheter and Guidewire Control Systems.” Each of the aforementioned applications is incorporated herein by reference in its entirety.

US Referenced Citations (875)
Number Name Date Kind
2211975 Hendrickson Aug 1940 A
2259488 Raiche Oct 1941 A
2330400 Winder Sep 1943 A
D138589 Brandenburg Aug 1944 S
3185151 Czorny May 1965 A
3297030 Czorny et al. Jan 1967 A
3416567 von Dardel et al. Dec 1968 A
3469579 Hubert Sep 1969 A
3500828 Podhora Mar 1970 A
3552384 Pierie et al. Jan 1971 A
3572334 Petterson Mar 1971 A
3585996 Reynolds et al. Jun 1971 A
3589361 Loper et al. Jun 1971 A
3592192 Harautuneian Jul 1971 A
3595230 Suyeoka et al. Jul 1971 A
3610240 Harautuneian Oct 1971 A
3682173 Center Aug 1972 A
3884242 Bazell et al. May 1975 A
3921631 Thompson Nov 1975 A
3995628 Gula et al. Dec 1976 A
4027668 Dunn Jun 1977 A
4037600 Poncy et al. Jul 1977 A
4079738 Dunn et al. Mar 1978 A
4106506 Koehn et al. Aug 1978 A
4177809 Moorehead Dec 1979 A
4292970 Hessian, Jr. Oct 1981 A
4317445 Robinson Mar 1982 A
4345602 Yoshimura et al. Aug 1982 A
4354491 Marbry Oct 1982 A
4368730 Sharrock Jan 1983 A
4387879 Tauschinski Jun 1983 A
4417886 Frankhouser et al. Nov 1983 A
4449693 Gereg May 1984 A
4456017 Miles Jun 1984 A
4464171 Garwin Aug 1984 A
4509534 Tassin, Jr. Apr 1985 A
4509945 Kramann et al. Apr 1985 A
4511359 Vaillancourt Apr 1985 A
4512766 Vailancourt Apr 1985 A
4581019 Curelaru et al. Apr 1986 A
4585440 Tchervenkov et al. Apr 1986 A
D287877 Holewinski et al. Jan 1987 S
4728322 Walker et al. Mar 1988 A
4738659 Sleiman Apr 1988 A
4747831 Kulli May 1988 A
4767407 Foran Aug 1988 A
4772264 Cragg Sep 1988 A
4772267 Brown Sep 1988 A
4781703 Walker et al. Nov 1988 A
4792531 Kakihana Dec 1988 A
4798193 Giesy et al. Jan 1989 A
4813934 Engelson et al. Mar 1989 A
4826070 Kakihana May 1989 A
4828547 Sahi et al. May 1989 A
4834708 Pillari May 1989 A
4834718 McDonald May 1989 A
4840613 Balbierz Jun 1989 A
4840622 Hardy Jun 1989 A
4842591 Luther Jun 1989 A
4846812 Walker et al. Jul 1989 A
4869259 Elkins Sep 1989 A
D304079 McFarlane Oct 1989 S
4871358 Gold Oct 1989 A
4874377 Newgard et al. Oct 1989 A
4883461 Sawyer Nov 1989 A
4883699 Aniuk et al. Nov 1989 A
4894052 Crawford Jan 1990 A
4895346 Steigerwald Jan 1990 A
4900307 Kulli Feb 1990 A
4906956 Kakihana Mar 1990 A
4908021 McFarlane Mar 1990 A
4909793 Vining et al. Mar 1990 A
4911691 Aniuk et al. Mar 1990 A
4913704 Kurimoto Apr 1990 A
4917102 Miller et al. Apr 1990 A
4917671 Chang Apr 1990 A
4929235 Merry et al. May 1990 A
4935010 Cox et al. Jun 1990 A
4944725 McDonald Jul 1990 A
4944728 Carrell et al. Jul 1990 A
4955863 Walker et al. Sep 1990 A
4961729 Vaillancourt Oct 1990 A
4966586 Vaillancourt Oct 1990 A
4966589 Kaufman Oct 1990 A
4994042 Vadher Feb 1991 A
4994047 Walker et al. Feb 1991 A
4995866 Amplatz et al. Feb 1991 A
5007901 Shields Apr 1991 A
5009642 Sahi Apr 1991 A
5019048 Margolin May 1991 A
5019049 Haining May 1991 A
D318733 Wyzgala Jul 1991 S
5034347 Kakihana Jul 1991 A
5047013 Rossdeutscher Sep 1991 A
D321250 Jepson et al. Oct 1991 S
5053014 Van Heugten Oct 1991 A
5054501 Chuttani et al. Oct 1991 A
5061254 Karakelle et al. Oct 1991 A
5064416 Newgard et al. Nov 1991 A
5078694 Wallace Jan 1992 A
5078696 Nedbaluk Jan 1992 A
5078702 Pomeranz Jan 1992 A
5084023 Lemieux Jan 1992 A
5085645 Purdy et al. Feb 1992 A
5088984 Fields Feb 1992 A
5093692 Su et al. Mar 1992 A
5098392 Fleischhacker et al. Mar 1992 A
5098395 Fields Mar 1992 A
5098405 Peterson et al. Mar 1992 A
5108375 Harrison et al. Apr 1992 A
5108376 Bonaldo Apr 1992 A
5112312 Luther May 1992 A
5116323 Kreuzer et al. May 1992 A
5120317 Luther Jun 1992 A
5125906 Fleck Jun 1992 A
5135487 Morrill et al. Aug 1992 A
5137515 Hogan Aug 1992 A
5149326 Woodgrift et al. Sep 1992 A
5154703 Bonaldo Oct 1992 A
5156590 Vilmar Oct 1992 A
5156596 Balbierz et al. Oct 1992 A
5158544 Weinstein Oct 1992 A
5167637 Okada et al. Dec 1992 A
5176650 Haining Jan 1993 A
5186168 Spofford et al. Feb 1993 A
5186712 Kelso et al. Feb 1993 A
5188607 Wu Feb 1993 A
5190528 Fonger et al. Mar 1993 A
5192301 Kamiya et al. Mar 1993 A
5195974 Hardy Mar 1993 A
5195980 Catlin Mar 1993 A
5195985 Hall Mar 1993 A
5205830 Dassa et al. Apr 1993 A
5215527 Beck et al. Jun 1993 A
5215528 Purdy et al. Jun 1993 A
5217435 Kring Jun 1993 A
5219335 Willard et al. Jun 1993 A
5221255 Mahurkar et al. Jun 1993 A
5222944 Harris Jun 1993 A
5225369 Su et al. Jul 1993 A
5226899 Lee et al. Jul 1993 A
D338955 Gresl et al. Aug 1993 S
5234410 Graham et al. Aug 1993 A
5242411 Yamamoto et al. Sep 1993 A
5246426 Lewis et al. Sep 1993 A
5246430 MacFarlane Sep 1993 A
5254107 Soltesz Oct 1993 A
5257980 Van Antwerp et al. Nov 1993 A
5267982 Sylvanowicz Dec 1993 A
5269771 Thomas et al. Dec 1993 A
D345419 Horrigan et al. Mar 1994 S
5290310 Makower et al. Mar 1994 A
5297546 Spofford et al. Mar 1994 A
5312359 Wallace May 1994 A
5312361 Zadini et al. May 1994 A
5320608 Gerrone Jun 1994 A
5322517 Sircom et al. Jun 1994 A
5330435 Vaillancourt Jul 1994 A
5334159 Turkel Aug 1994 A
5338311 Mahurkar Aug 1994 A
5352205 Dales et al. Oct 1994 A
5358796 Nakamura et al. Oct 1994 A
5366441 Crawford Nov 1994 A
5368661 Nakamura et al. Nov 1994 A
D353668 Banks et al. Dec 1994 S
5376082 Phelps Dec 1994 A
5376094 Kline Dec 1994 A
5380290 Makower et al. Jan 1995 A
5380292 Wilson Jan 1995 A
5395341 Slater Mar 1995 A
5397311 Walker et al. Mar 1995 A
5405323 Rogers et al. Apr 1995 A
5415177 Zadini et al. May 1995 A
5415645 Friend et al. May 1995 A
5419766 Chang et al. May 1995 A
5419777 Hofling May 1995 A
5423760 Yoon Jun 1995 A
5425718 Tay et al. Jun 1995 A
5431506 Masunaga Jul 1995 A
5445625 Voda Aug 1995 A
5454785 Smith Oct 1995 A
5454790 Dubrul Oct 1995 A
5456258 Kondo et al. Oct 1995 A
5456668 Ogle, II Oct 1995 A
5458658 Sircom Oct 1995 A
5466230 Davila Nov 1995 A
5480389 McWha et al. Jan 1996 A
5482395 Gasparini Jan 1996 A
5484419 Fleck Jan 1996 A
5487734 Thorne et al. Jan 1996 A
5489273 Whitney et al. Feb 1996 A
5496281 Krebs Mar 1996 A
5501675 Erskine Mar 1996 A
5507300 Mukai et al. Apr 1996 A
5512052 Jesch Apr 1996 A
5514108 Stevens May 1996 A
5520655 Davila et al. May 1996 A
5520657 Sellers et al. May 1996 A
D371195 Krebs Jun 1996 S
5522807 Luther Jun 1996 A
5527290 Zadini et al. Jun 1996 A
5531701 Luther Jul 1996 A
5531713 Mastronardi et al. Jul 1996 A
5533988 Dickerson et al. Jul 1996 A
5535785 Werge et al. Jul 1996 A
5542933 Marks Aug 1996 A
5554136 Luther Sep 1996 A
5562629 Haughton et al. Oct 1996 A
5562630 Nichols Oct 1996 A
5562631 Bogert Oct 1996 A
5562633 Wozencroft et al. Oct 1996 A
5562634 Flumene et al. Oct 1996 A
5569202 Kovalic et al. Oct 1996 A
5569217 Luther Oct 1996 A
5571073 Castillo Nov 1996 A
5573510 Isaacson Nov 1996 A
5591194 Berthiaume Jan 1997 A
5599291 Balbierz et al. Feb 1997 A
5599327 Sugahara et al. Feb 1997 A
5609583 Hakki et al. Mar 1997 A
5613663 Schmidt et al. Mar 1997 A
5613954 Nelson et al. Mar 1997 A
5630802 Moellmann et al. May 1997 A
5630823 Schmitz-Rode et al. May 1997 A
5634475 Wolvek Jun 1997 A
5634913 Stinger Jun 1997 A
5637091 Hakky et al. Jun 1997 A
5645076 Yoon Jul 1997 A
5651772 Arnett Jul 1997 A
D383538 Erskine et al. Sep 1997 S
5662622 Gore et al. Sep 1997 A
5674241 Bley et al. Oct 1997 A
5676658 Erskine Oct 1997 A
5683368 Schmidt Nov 1997 A
5683370 Luther et al. Nov 1997 A
5685855 Erskine Nov 1997 A
5685858 Kawand Nov 1997 A
5685860 Chang et al. Nov 1997 A
5688249 Chang et al. Nov 1997 A
5693025 Stevens Dec 1997 A
5695474 Daugherty Dec 1997 A
5700250 Erskine Dec 1997 A
5702369 Mercereau Dec 1997 A
5704914 Stocking et al. Jan 1998 A
5722425 Bostrom Mar 1998 A
5725503 Arnett Mar 1998 A
5730150 Peppel et al. Mar 1998 A
5730733 Mortier et al. Mar 1998 A
5730741 Horzewski et al. Mar 1998 A
5738144 Rogers Apr 1998 A
5738660 Luther Apr 1998 A
5743882 Luther Apr 1998 A
5743888 Wilkes et al. Apr 1998 A
5749371 Zadini et al. May 1998 A
5749857 Cuppy May 1998 A
5750741 Crocker et al. May 1998 A
5755693 Walker et al. May 1998 A
5755709 Cuppy May 1998 A
5762630 Bley et al. Jun 1998 A
5762636 Rupp et al. Jun 1998 A
5765682 Bley et al. Jun 1998 A
5779679 Shaw Jul 1998 A
5779680 Yoon Jul 1998 A
5779681 Bonn Jul 1998 A
5782807 Falvai et al. Jul 1998 A
D397434 Pike Aug 1998 S
5792124 Harrigan et al. Aug 1998 A
5800395 Botich et al. Sep 1998 A
5807339 Bostrom et al. Sep 1998 A
5807342 Musgrave et al. Sep 1998 A
5807350 Diaz Sep 1998 A
5810835 Ryan et al. Sep 1998 A
5813411 Van Bladel et al. Sep 1998 A
5817058 Shaw Oct 1998 A
5817069 Arnett Oct 1998 A
5824001 Erskine Oct 1998 A
5827202 Miraki et al. Oct 1998 A
5827221 Phelps Oct 1998 A
5827227 DeLago Oct 1998 A
5830190 Howell Nov 1998 A
5839470 Hiejima et al. Nov 1998 A
5843038 Bailey Dec 1998 A
5846259 Berthiaume Dec 1998 A
5851196 Arnett Dec 1998 A
5853393 Bogert Dec 1998 A
5855615 Bley et al. Jan 1999 A
5858002 Jesch Jan 1999 A
5865806 Howell Feb 1999 A
5873864 Luther et al. Feb 1999 A
5879332 Schwemberger et al. Mar 1999 A
5885217 Gisselberg et al. Mar 1999 A
5885251 Luther Mar 1999 A
5891098 Huang Apr 1999 A
5891105 Mahurkar Apr 1999 A
5895398 Wensel et al. Apr 1999 A
5902274 Yamamoto et al. May 1999 A
5902832 Van Bladel et al. May 1999 A
5911705 Howell Jun 1999 A
5911710 Barry et al. Jun 1999 A
5913848 Luther et al. Jun 1999 A
5916208 Luther et al. Jun 1999 A
5928199 Nakagami Jul 1999 A
5935110 Brimhall Aug 1999 A
5941854 Bhitiyakul Aug 1999 A
5944690 Falwell et al. Aug 1999 A
5947930 Schwemberger et al. Sep 1999 A
5951520 Burzynski et al. Sep 1999 A
5954698 Pike Sep 1999 A
5957893 Luther et al. Sep 1999 A
5964744 Balbierz et al. Oct 1999 A
5967490 Pike Oct 1999 A
5984895 Padilla et al. Nov 1999 A
5984903 Nadal Nov 1999 A
5989220 Shaw et al. Nov 1999 A
5989271 Bonnette et al. Nov 1999 A
5997507 Dysart Dec 1999 A
5997510 Schwemberger Dec 1999 A
6004278 Botich et al. Dec 1999 A
6004294 Brimhall et al. Dec 1999 A
6004295 Langer et al. Dec 1999 A
6011988 Lynch et al. Jan 2000 A
6019736 Avellanet et al. Feb 2000 A
6022319 Willard et al. Feb 2000 A
6024727 Thorne et al. Feb 2000 A
6045734 Luther et al. Apr 2000 A
6056726 Isaacson May 2000 A
6066100 Willard et al. May 2000 A
6074378 Mouri et al. Jun 2000 A
6077244 Botich et al. Jun 2000 A
6080137 Pike Jun 2000 A
6083237 Huitema et al. Jul 2000 A
6096004 Meglan et al. Aug 2000 A
6096005 Botich et al. Aug 2000 A
6120494 Jonkman Sep 2000 A
6126641 Shields Oct 2000 A
6139532 Howell et al. Oct 2000 A
6139557 Passafaro et al. Oct 2000 A
6159179 Simonson Dec 2000 A
6171234 White et al. Jan 2001 B1
6171287 Lynn et al. Jan 2001 B1
6176842 Tachibana et al. Jan 2001 B1
6193690 Dysarz Feb 2001 B1
6197001 Wilson et al. Mar 2001 B1
6197007 Thorne et al. Mar 2001 B1
6197041 Shichman et al. Mar 2001 B1
6203527 Zadini et al. Mar 2001 B1
6213978 Voyten Apr 2001 B1
6217558 Zadini et al. Apr 2001 B1
6221047 Green et al. Apr 2001 B1
6221049 Selmon et al. Apr 2001 B1
6224569 Brimhall May 2001 B1
6228060 Howell May 2001 B1
6228062 Howell et al. May 2001 B1
6228073 Noone et al. May 2001 B1
6245045 Stratienko Jun 2001 B1
6251092 Qin et al. Jun 2001 B1
6268399 Hultine et al. Jul 2001 B1
6270480 Dorr et al. Aug 2001 B1
6273871 Davis et al. Aug 2001 B1
6280419 Vojtasek Aug 2001 B1
6309379 Willard et al. Oct 2001 B1
6319244 Suresh et al. Nov 2001 B2
6322537 Chang Nov 2001 B1
D452003 Niermann Dec 2001 S
6325781 Takagi et al. Dec 2001 B1
6325797 Stewart et al. Dec 2001 B1
6336914 Gillespie, III Jan 2002 B1
6352520 Miyazaki et al. Mar 2002 B1
6368337 Kieturakis et al. Apr 2002 B1
6379333 Brimhall et al. Apr 2002 B1
6379372 Dehdashtian et al. Apr 2002 B1
D457955 Bilitz May 2002 S
6406442 McFann et al. Jun 2002 B1
D460179 Isoda et al. Jul 2002 S
6422989 Hektner Jul 2002 B1
6436070 Botich et al. Aug 2002 B1
6436112 Wensel et al. Aug 2002 B2
6451052 Burmeister et al. Sep 2002 B1
6461362 Halseth et al. Oct 2002 B1
6475217 Platt Nov 2002 B1
6478779 Hu Nov 2002 B1
6485473 Lynn Nov 2002 B1
6485497 Wensel et al. Nov 2002 B2
6497681 Brenner Dec 2002 B1
6506181 Meng et al. Jan 2003 B2
6514236 Stratienko Feb 2003 B1
6524276 Halseth et al. Feb 2003 B1
D471980 Caizza Mar 2003 S
6527759 Tachibana et al. Mar 2003 B1
6530913 Giba et al. Mar 2003 B1
6530935 Wensel et al. Mar 2003 B2
6540725 Ponzi Apr 2003 B1
6540732 Botich et al. Apr 2003 B1
6544239 Kinsey et al. Apr 2003 B2
6547762 Botich et al. Apr 2003 B1
6558355 Metzger et al. May 2003 B1
6582402 Erskine Jun 2003 B1
6582440 Brumbach Jun 2003 B1
6585703 Kassel et al. Jul 2003 B1
6589262 Honebrink et al. Jul 2003 B1
6595955 Ferguson et al. Jul 2003 B2
6595959 Stratienko Jul 2003 B1
6607511 Halseth et al. Aug 2003 B2
6616630 Woehr et al. Sep 2003 B1
6620136 Pressly, Sr. et al. Sep 2003 B1
6623449 Paskar Sep 2003 B2
6626868 Prestidge et al. Sep 2003 B1
6626869 Bint Sep 2003 B1
6632201 Mathias et al. Oct 2003 B1
6638252 Moulton et al. Oct 2003 B2
6641564 Kraus Nov 2003 B1
6645178 Junker et al. Nov 2003 B1
6652486 Bialecki et al. Nov 2003 B2
6652490 Howell Nov 2003 B2
6663577 Jen et al. Dec 2003 B2
6663592 Rhad et al. Dec 2003 B2
6666865 Platt Dec 2003 B2
6679900 Kieturakis et al. Jan 2004 B2
6689102 Greene Feb 2004 B2
6692508 Wensel et al. Feb 2004 B2
6692509 Wensel et al. Feb 2004 B2
6695814 Greene et al. Feb 2004 B2
6695856 Kieturakis et al. Feb 2004 B2
6695860 Ward et al. Feb 2004 B1
6699221 Vaillancourt Mar 2004 B2
6702811 Stewart et al. Mar 2004 B2
6706018 Westlund et al. Mar 2004 B2
6711444 Koblish Mar 2004 B2
6712790 Prestidge et al. Mar 2004 B1
6712797 Southern, Jr. Mar 2004 B1
6716197 Svendsen Apr 2004 B2
6730062 Hoffman et al. May 2004 B2
6740063 Lynn May 2004 B2
6740096 Teague et al. May 2004 B2
6745080 Koblish Jun 2004 B2
6749588 Howell et al. Jun 2004 B1
6764468 East Jul 2004 B1
D494270 Reschke Aug 2004 S
6776788 Klint et al. Aug 2004 B1
6796962 Ferguson et al. Sep 2004 B2
6824545 Sepetka et al. Nov 2004 B2
6832715 Eungard et al. Dec 2004 B2
6835190 Nguyen Dec 2004 B2
6837867 Kortelling Jan 2005 B2
6860871 Kuracina et al. Mar 2005 B2
6872193 Shaw et al. Mar 2005 B2
6887220 Hogendijk May 2005 B2
6902546 Ferguson Jun 2005 B2
6905483 Newby et al. Jun 2005 B2
6913595 Mastorakis Jul 2005 B2
6916311 Vojtasek Jul 2005 B2
6921386 Shue et al. Jul 2005 B2
6921391 Barker et al. Jul 2005 B1
6929624 Del Castillo Aug 2005 B1
6939325 Haining Sep 2005 B2
6942652 Pressly, Sr. et al. Sep 2005 B1
6953448 Moulton et al. Oct 2005 B2
6958054 Fitzgerald Oct 2005 B2
6958055 Donnan et al. Oct 2005 B2
6960191 Howlett et al. Nov 2005 B2
6972002 Thorne Dec 2005 B2
6974438 Shekalim Dec 2005 B2
6994693 Tal Feb 2006 B2
7001396 Glazier et al. Feb 2006 B2
7004927 Ferguson et al. Feb 2006 B2
7008404 Nakajima Mar 2006 B2
7018372 Casey et al. Mar 2006 B2
7018390 Turovskiy et al. Mar 2006 B2
7025746 Tal Apr 2006 B2
7029467 Currier et al. Apr 2006 B2
7033335 Haarala et al. Apr 2006 B2
7044935 Shue et al. May 2006 B2
7060055 Wilkinson et al. Jun 2006 B2
7090656 Botich et al. Aug 2006 B1
7094243 Mulholland et al. Aug 2006 B2
7097633 Botich et al. Aug 2006 B2
7125396 Leinsing et al. Oct 2006 B2
7141040 Lichtenberg Nov 2006 B2
7153276 Barker et al. Dec 2006 B2
7163520 Bernard et al. Jan 2007 B2
7169159 Green et al. Jan 2007 B2
7179244 Smith et al. Feb 2007 B2
7191900 Opie et al. Mar 2007 B2
7192433 Osypka et al. Mar 2007 B2
7204813 Shue et al. Apr 2007 B2
7291130 McGurk Nov 2007 B2
7303547 Pressly, Sr. et al. Dec 2007 B2
7303548 Rhad et al. Dec 2007 B2
7314462 O'Reagan et al. Jan 2008 B2
7331966 Soma et al. Feb 2008 B2
7344516 Erskine Mar 2008 B2
7354422 Riesenberger et al. Apr 2008 B2
7381205 Thommen Jun 2008 B2
7396346 Nakajima Jul 2008 B2
7413562 Ferguson et al. Aug 2008 B2
7422572 Popov et al. Sep 2008 B2
7458954 Ferguson et al. Dec 2008 B2
7465294 Vladimirsky Dec 2008 B1
7468057 Ponzi Dec 2008 B2
7470254 Basta et al. Dec 2008 B2
7491176 Mann Feb 2009 B2
7494010 Opie et al. Feb 2009 B2
7500965 Menzi et al. Mar 2009 B2
7507222 Cindrich et al. Mar 2009 B2
7513887 Halseth et al. Apr 2009 B2
7513888 Sircom et al. Apr 2009 B2
7524306 Botich et al. Apr 2009 B2
7530965 Villa et al. May 2009 B2
7534227 Kulli May 2009 B2
7544170 Williams et al. Jun 2009 B2
7556617 Voorhees, Jr. et al. Jul 2009 B2
7566323 Chang Jul 2009 B2
D601243 Bierman et al. Sep 2009 S
7597681 Sutton et al. Oct 2009 B2
D604839 Crawford et al. Nov 2009 S
7611485 Ferguson Nov 2009 B2
7618395 Ferguson Nov 2009 B2
7628769 Grandt et al. Dec 2009 B2
7632243 Bialecki et al. Dec 2009 B2
7645263 Angel et al. Jan 2010 B2
7654988 Moulton et al. Feb 2010 B2
7658725 Bialecki et al. Feb 2010 B2
D612043 Young et al. Mar 2010 S
7678080 Shue et al. Mar 2010 B2
7682358 Gullickson et al. Mar 2010 B2
7691088 Howell Apr 2010 B2
7691090 Belley et al. Apr 2010 B2
7691093 Brimhall Apr 2010 B2
7695458 Belley et al. Apr 2010 B2
7699807 Faust et al. Apr 2010 B2
D615197 Koh et al. May 2010 S
7708721 Khaw May 2010 B2
7713243 Hillman May 2010 B2
7717875 Knudson et al. May 2010 B2
7722567 Tal May 2010 B2
7722569 Soderholm et al. May 2010 B2
D617893 Bierman et al. Jun 2010 S
7731691 Cote et al. Jun 2010 B2
7736332 Carlyon et al. Jun 2010 B2
7736337 Diep et al. Jun 2010 B2
7736339 Woehr et al. Jun 2010 B2
7736342 Abriles et al. Jun 2010 B2
7740615 Shaw et al. Jun 2010 B2
7744574 Pederson et al. Jun 2010 B2
7753877 Bialecki et al. Jul 2010 B2
7753887 Botich et al. Jul 2010 B2
7762984 Kumoyama et al. Jul 2010 B2
7762993 Perez Jul 2010 B2
7766879 Tan et al. Aug 2010 B2
7776052 Greenberg et al. Aug 2010 B2
7785296 Muskatello et al. Aug 2010 B2
7794424 Paskar Sep 2010 B2
7798994 Brimhall Sep 2010 B2
7803142 Longson et al. Sep 2010 B2
7828773 Swisher et al. Nov 2010 B2
7828774 Harding et al. Nov 2010 B2
7850644 Gonzalez et al. Dec 2010 B2
D634843 Kim et al. Mar 2011 S
7896862 Long et al. Mar 2011 B2
7905857 Swisher Mar 2011 B2
7914488 Dickerson Mar 2011 B2
7914492 Heuser Mar 2011 B2
7922696 Tal et al. Apr 2011 B2
7922698 Riesenberger et al. Apr 2011 B2
7927314 Kuracina et al. Apr 2011 B2
7935080 Howell et al. May 2011 B2
7959613 Rhad et al. Jun 2011 B2
7972324 Quint Jul 2011 B2
8029470 Whiting et al. Oct 2011 B2
8029472 Leinsing et al. Oct 2011 B2
8048031 Shaw et al. Nov 2011 B2
8048039 Carlyon et al. Nov 2011 B2
8057404 Fujiwara et al. Nov 2011 B2
8079979 Moorehead Dec 2011 B2
D653329 Lee-Sepsick Jan 2012 S
8105286 Anderson et al. Jan 2012 B2
8105315 Johnson et al. Jan 2012 B2
8123727 Luther et al. Feb 2012 B2
8152758 Chan et al. Apr 2012 B2
8162881 Lilley, Jr. et al. Apr 2012 B2
8167851 Sen May 2012 B2
8177753 Vitullo et al. May 2012 B2
RE43473 Newby et al. Jun 2012 E
8192402 Anderson et al. Jun 2012 B2
8202253 Wexler Jun 2012 B1
8206343 Racz Jun 2012 B2
8221387 Shelso et al. Jul 2012 B2
8251923 Carrez et al. Aug 2012 B2
8251950 Albert et al. Aug 2012 B2
D667111 Robinson Sep 2012 S
8257322 Koehler et al. Sep 2012 B2
8273054 St Germain et al. Sep 2012 B2
8286657 Belley et al. Oct 2012 B2
8298186 Popov Oct 2012 B2
8308691 Woehr et al. Nov 2012 B2
D672456 Lee-Sepsick Dec 2012 S
8328762 Woehr et al. Dec 2012 B2
8328837 Binmoeller Dec 2012 B2
8333735 Woehr et al. Dec 2012 B2
8337463 Woehr et al. Dec 2012 B2
8337471 Baid Dec 2012 B2
D675318 Luk et al. Jan 2013 S
8361020 Stout Jan 2013 B2
8377006 Tal et al. Feb 2013 B2
8388583 Stout et al. Mar 2013 B2
8403886 Bialecki et al. Mar 2013 B2
8412300 Sonderegger Apr 2013 B2
8419688 Woehr et al. Apr 2013 B2
8454536 Raulerson et al. Jun 2013 B2
8460247 Woehr et al. Jun 2013 B2
8469928 Stout et al. Jun 2013 B2
8496628 Erskine Jul 2013 B2
D687548 Hayashi Aug 2013 S
8506533 Carlyon et al. Aug 2013 B2
8509340 Michelitsch Aug 2013 B2
8517959 Kurosawa et al. Aug 2013 B2
8535271 Fuchs et al. Sep 2013 B2
8540728 Woehr et al. Sep 2013 B2
8574203 Stout et al. Nov 2013 B2
8585660 Murphy Nov 2013 B2
8591467 Walker et al. Nov 2013 B2
8591468 Woehr et al. Nov 2013 B2
8597249 Woehr et al. Dec 2013 B2
8622931 Teague et al. Jan 2014 B2
8622972 Nystrom et al. Jan 2014 B2
D700318 Amoah et al. Feb 2014 S
8647301 Bialecki et al. Feb 2014 B2
8647313 Woehr et al. Feb 2014 B2
8647324 DeLegge et al. Feb 2014 B2
8652104 Goral et al. Feb 2014 B2
8657790 Tal et al. Feb 2014 B2
8672888 Tal Mar 2014 B2
8679063 Stout et al. Mar 2014 B2
8690833 Belson Apr 2014 B2
8721546 Belson May 2014 B2
8728030 Woehr May 2014 B2
8728035 Warring et al. May 2014 B2
8740964 Hartley Jun 2014 B2
8747387 Belley et al. Jun 2014 B2
8753317 Osborne et al. Jun 2014 B2
8764711 Kuracina et al. Jul 2014 B2
D710495 Wu et al. Aug 2014 S
8814833 Farrell et al. Aug 2014 B2
D713957 Woehr et al. Sep 2014 S
D714436 Lee-Sepsick Sep 2014 S
8845584 Ferguson et al. Sep 2014 B2
D715931 Watanabe et al. Oct 2014 S
8864714 Harding et al. Oct 2014 B2
8900192 Anderson et al. Dec 2014 B2
8932257 Woehr Jan 2015 B2
8932258 Blanchard et al. Jan 2015 B2
8956327 Bierman et al. Feb 2015 B2
8974426 Corcoran et al. Mar 2015 B2
8979802 Woehr Mar 2015 B2
8986227 Belson Mar 2015 B2
D726908 Yu et al. Apr 2015 S
8998852 Blanchard et al. Apr 2015 B2
9005169 Gravesen et al. Apr 2015 B2
9011351 Hoshinouchi Apr 2015 B2
9011381 Yamada et al. Apr 2015 B2
D728781 Pierson et al. May 2015 S
9033927 Maan et al. May 2015 B2
D733289 Blanchard et al. Jun 2015 S
9044583 Vaillancourt Jun 2015 B2
D735321 Blanchard Jul 2015 S
9095683 Hall et al. Aug 2015 B2
9101746 Stout et al. Aug 2015 B2
9114241 Stout et al. Aug 2015 B2
9138252 Bierman et al. Sep 2015 B2
9138545 Shaw et al. Sep 2015 B2
9138559 Odland et al. Sep 2015 B2
RE45776 Root et al. Oct 2015 E
D740410 Korkuch et al. Oct 2015 S
9162036 Caples et al. Oct 2015 B2
9162037 Belson et al. Oct 2015 B2
9180275 Helm Nov 2015 B2
D746445 Lazarus Dec 2015 S
9216109 Badawi et al. Dec 2015 B2
9220531 Datta et al. Dec 2015 B2
9220871 Thorne et al. Dec 2015 B2
D748254 Freigang et al. Jan 2016 S
9227038 Woehr Jan 2016 B2
D748774 Caron Feb 2016 S
D748777 Uenishi et al. Feb 2016 S
D749214 Uenishi et al. Feb 2016 S
D749727 Wapler et al. Feb 2016 S
D751194 Yu et al. Mar 2016 S
D752737 Ohashi Mar 2016 S
D755368 Efinger et al. May 2016 S
9522254 Belson Dec 2016 B2
9616201 Belson Apr 2017 B2
9675784 Belson Jun 2017 B2
9757540 Belson Sep 2017 B2
20010014786 Greene et al. Aug 2001 A1
20010020153 Howell Sep 2001 A1
20020077595 Hundertmark et al. Jun 2002 A1
20020103446 McFann et al. Aug 2002 A1
20020107526 Greenberg et al. Aug 2002 A1
20020128604 Nakajima Sep 2002 A1
20020165497 Greene Nov 2002 A1
20020177812 Moulton et al. Nov 2002 A1
20030032922 Moorehead Feb 2003 A1
20030032936 Lederman Feb 2003 A1
20030060760 Botich et al. Mar 2003 A1
20030073956 Hoffman et al. Apr 2003 A1
20030120214 Howell Jun 2003 A1
20030153874 Tal Aug 2003 A1
20030187396 Ponzi Oct 2003 A1
20030204186 Geistert Oct 2003 A1
20040019329 Erskine Jan 2004 A1
20040044302 Bernard et al. Mar 2004 A1
20040044313 Nakajima Mar 2004 A1
20040092879 Kraus et al. May 2004 A1
20040106903 Shue et al. Jun 2004 A1
20040111059 Howlett et al. Jun 2004 A1
20040122373 Botich et al. Jun 2004 A1
20040176758 Yassinzadeh Sep 2004 A1
20040193118 Bergeron Sep 2004 A1
20040236288 Howell et al. Nov 2004 A1
20040243061 McGurk Dec 2004 A1
20040267204 Brustowicz Dec 2004 A1
20050004524 Newby et al. Jan 2005 A1
20050010095 Stewart et al. Jan 2005 A1
20050020940 Opie et al. Jan 2005 A1
20050027256 Barker et al. Feb 2005 A1
20050033137 Oral et al. Feb 2005 A1
20050040061 Opie et al. Feb 2005 A1
20050075606 Botich et al. Apr 2005 A1
20050107769 Thommen May 2005 A1
20050119619 Haining Jun 2005 A1
20050131350 Shaw et al. Jun 2005 A1
20050165355 Fitzgerald Jul 2005 A1
20050197623 Leeflang et al. Sep 2005 A1
20050245847 Schaeffer Nov 2005 A1
20050256505 Long et al. Nov 2005 A1
20050273057 Popov Dec 2005 A1
20060025721 Duffy et al. Feb 2006 A1
20060079787 Whiting et al. Apr 2006 A1
20060084964 Knudson et al. Apr 2006 A1
20060155245 Woehr Jul 2006 A1
20060167405 King et al. Jul 2006 A1
20060229563 O'Reagan et al. Oct 2006 A1
20060264834 Vaillancourt Nov 2006 A1
20070043422 Shmulewitz et al. Feb 2007 A1
20070060999 Randall et al. Mar 2007 A1
20070083162 O'Reagan et al. Apr 2007 A1
20070083188 Grandt et al. Apr 2007 A1
20070100284 Leinsing et al. May 2007 A1
20070123803 Fujiwara et al. May 2007 A1
20070142779 Duane et al. Jun 2007 A1
20070179446 Carrez et al. Aug 2007 A1
20070191777 King Aug 2007 A1
20070193903 Opie et al. Aug 2007 A1
20070225647 Luther et al. Sep 2007 A1
20070244438 Perez Oct 2007 A1
20070276288 Khaw Nov 2007 A1
20080097330 King et al. Apr 2008 A1
20080108911 Palmer May 2008 A1
20080108944 Woehr et al. May 2008 A1
20080108974 Yee Roth May 2008 A1
20080125709 Chang et al. May 2008 A1
20080131300 Junod et al. Jun 2008 A1
20080243165 Mauch et al. Oct 2008 A1
20080262430 Anderson et al. Oct 2008 A1
20080262431 Anderson et al. Oct 2008 A1
20080294111 Tal et al. Nov 2008 A1
20080300574 Belson et al. Dec 2008 A1
20090030380 Binmoeller Jan 2009 A1
20090036836 Nystrom et al. Feb 2009 A1
20090048566 Ferguson et al. Feb 2009 A1
20090131872 Popov May 2009 A1
20090157006 Nardeo et al. Jun 2009 A1
20090221961 Tal et al. Sep 2009 A1
20090292243 Harding et al. Nov 2009 A1
20090299291 Baid Dec 2009 A1
20100010447 Luther et al. Jan 2010 A1
20100036331 Sen Feb 2010 A1
20100087787 Woehr et al. Apr 2010 A1
20100094310 Warring et al. Apr 2010 A1
20100168674 Shaw et al. Jul 2010 A1
20100204654 Mulholland et al. Aug 2010 A1
20100204675 Woehr et al. Aug 2010 A1
20100210934 Belson Aug 2010 A1
20100246707 Michelitsch Sep 2010 A1
20100331732 Raulerson et al. Dec 2010 A1
20110009827 Bierman et al. Jan 2011 A1
20110015573 Maan et al. Jan 2011 A1
20110021994 Anderson et al. Jan 2011 A1
20110125097 Shaw et al. May 2011 A1
20110137252 Oster et al. Jun 2011 A1
20110196315 Chappel Aug 2011 A1
20110207157 Gautier et al. Aug 2011 A1
20110218496 Bierman Sep 2011 A1
20110251559 Tal et al. Oct 2011 A1
20110276002 Bierman Nov 2011 A1
20110282285 Blanchard et al. Nov 2011 A1
20110288482 Farrell et al. Nov 2011 A1
20110306933 Djordjevic et al. Dec 2011 A1
20110319838 Goral et al. Dec 2011 A1
20120053523 Harding Mar 2012 A1
20120078231 Hoshinouchi Mar 2012 A1
20120123332 Erskine May 2012 A1
20120157854 Kurrus et al. Jun 2012 A1
20120184896 DeLegge et al. Jul 2012 A1
20120197200 Belson Aug 2012 A1
20120220942 Hall et al. Aug 2012 A1
20120220956 Kuracina et al. Aug 2012 A1
20120259293 Bialecki et al. Oct 2012 A1
20120271232 Katsurada et al. Oct 2012 A1
20120296282 Koehler et al. Nov 2012 A1
20120316500 Bierman et al. Dec 2012 A1
20120323181 Shaw et al. Dec 2012 A1
20130204206 Morgan et al. Aug 2013 A1
20130204226 Keyser Aug 2013 A1
20130218082 Hyer et al. Aug 2013 A1
20130304030 Gray et al. Nov 2013 A1
20130324930 Fuchs et al. Dec 2013 A1
20140012203 Woehr et al. Jan 2014 A1
20140031752 Blanchard et al. Jan 2014 A1
20140039461 Anderson et al. Feb 2014 A1
20140058357 Keyser et al. Feb 2014 A1
20140073928 Yamashita et al. Mar 2014 A1
20140074034 Tanabe et al. Mar 2014 A1
20140088509 Sonderegger et al. Mar 2014 A1
20140094774 Blanchard Apr 2014 A1
20140094836 Feng et al. Apr 2014 A1
20140114239 Dib et al. Apr 2014 A1
20140128775 Andreae et al. May 2014 A1
20140135702 Woehr et al. May 2014 A1
20140135703 Yeh et al. May 2014 A1
20140180250 Belson Jun 2014 A1
20140188003 Belson Jul 2014 A1
20140194853 Morgan et al. Jul 2014 A1
20140214005 Belson Jul 2014 A1
20140221977 Belson Aug 2014 A1
20140249488 Woehr Sep 2014 A1
20140257359 Tegels et al. Sep 2014 A1
20140276224 Ranganathan et al. Sep 2014 A1
20140276434 Woehr et al. Sep 2014 A1
20140336582 Tisci et al. Nov 2014 A1
20140357983 Toomey et al. Dec 2014 A1
20140364809 Isaacson et al. Dec 2014 A1
20140371715 Farrell et al. Dec 2014 A1
20140378867 Belson Dec 2014 A1
20150025467 Woehr Jan 2015 A1
20150038909 Christensen et al. Feb 2015 A1
20150038910 Harding et al. Feb 2015 A1
20150038943 Warring et al. Feb 2015 A1
20150051584 Korkuch et al. Feb 2015 A1
20150080801 Tanabe et al. Mar 2015 A1
20150080810 Henderson et al. Mar 2015 A1
20150088095 Luther et al. Mar 2015 A1
20150119806 Blanchard et al. Apr 2015 A1
20150119852 Wexler Apr 2015 A1
20150126932 Knutsson May 2015 A1
20150190168 Bierman et al. Jul 2015 A1
20150190617 Anderson et al. Jul 2015 A1
20150202414 Hwang Jul 2015 A1
20150224267 Farrell et al. Aug 2015 A1
20150231364 Blanchard et al. Aug 2015 A1
20150290431 Hall et al. Oct 2015 A1
20150306347 Yagi Oct 2015 A1
20150306356 Gill Oct 2015 A1
20150328434 Gaur Nov 2015 A1
20150328438 Baid Nov 2015 A1
20150359473 Garrett et al. Dec 2015 A1
20160015943 Belson et al. Jan 2016 A1
20160015945 Warring et al. Jan 2016 A1
20160022963 Belson Jan 2016 A1
20160256667 Ribelin et al. Sep 2016 A1
20160331938 Blanchard et al. Nov 2016 A1
20170087338 Belson Mar 2017 A1
20170209668 Belson Jul 2017 A1
20170259036 Belson Sep 2017 A1
20170361071 Belson Dec 2017 A1
Foreign Referenced Citations (117)
Number Date Country
710967 Sep 1999 AU
1178707 Apr 1998 CN
1319023 Oct 2001 CN
1523970 Aug 2004 CN
101242868 Aug 2008 CN
102939129 Feb 2013 CN
105073174 Nov 2015 CN
105188826 Dec 2015 CN
105705191 Jun 2016 CN
20210394 Sep 2002 DE
0314470 May 1989 EP
417764 Mar 1991 EP
475857 Mar 1992 EP
515710 Dec 1992 EP
567321 Oct 1993 EP
652020 May 1995 EP
747075 Dec 1996 EP
750916 Jan 1997 EP
778043 Jun 1997 EP
800790 Oct 1997 EP
832663 Apr 1998 EP
910988 Apr 1999 EP
942761 Sep 1999 EP
1075850 Feb 2001 EP
1378263 Jan 2004 EP
1418971 May 2004 EP
1457229 Sep 2004 EP
1611916 Jan 2006 EP
1907042 Apr 2008 EP
2150304 Feb 2010 EP
2272432 Jan 2011 EP
2569046 Mar 2013 EP
2003-159334 Jun 2003 JP
2004-130074 Apr 2004 JP
2004-223252 Aug 2004 JP
2005-137888 Jun 2005 JP
2009-500129 Jan 2009 JP
2010-088521 Apr 2010 JP
2013-529111 Jul 2013 JP
8301575 May 1983 WO
1983001575 May 1983 WO
1992013584 Aug 1992 WO
9222344 Dec 1992 WO
1992022344 Dec 1992 WO
1995011710 May 1995 WO
9519193 Jul 1995 WO
1995019193 Jul 1995 WO
9523003 Aug 1995 WO
1995023003 Aug 1995 WO
9632981 Oct 1996 WO
1996032981 Oct 1996 WO
1996040359 Dec 1996 WO
9705912 Feb 1997 WO
1997005912 Feb 1997 WO
9721458 Jun 1997 WO
1997021458 Jun 1997 WO
1997045151 Dec 1997 WO
9824494 Jun 1998 WO
1998024494 Jun 1998 WO
1998030268 Jul 1998 WO
1998053875 Dec 1998 WO
1999008742 Feb 1999 WO
1999026682 Jun 1999 WO
0006226 Feb 2000 WO
0012160 Mar 2000 WO
2000012167 Mar 2000 WO
0047256 Aug 2000 WO
2001007103 Feb 2001 WO
2002041932 May 2002 WO
02066093 Aug 2002 WO
0311381 Feb 2003 WO
03043686 May 2003 WO
0343686 May 2003 WO
03047675 Jun 2003 WO
0347675 Jun 2003 WO
2004018031 Mar 2004 WO
2004106203 Dec 2004 WO
2005002659 Jan 2005 WO
2005074412 Aug 2005 WO
2005087306 Sep 2005 WO
2006062996 Jun 2006 WO
2007006055 Jan 2007 WO
2007032343 Mar 2007 WO
2007094841 Aug 2007 WO
2007098355 Aug 2007 WO
2007098359 Aug 2007 WO
2008005618 Jan 2008 WO
2008030999 Mar 2008 WO
2008131300 Oct 2008 WO
2008137956 Nov 2008 WO
2009001309 Dec 2008 WO
2008147600 Dec 2008 WO
2009031161 Mar 2009 WO
2009114837 Sep 2009 WO
2009124990 Oct 2009 WO
2010015676 Feb 2010 WO
2010048449 Apr 2010 WO
2010132608 Nov 2010 WO
2011036574 Mar 2011 WO
2011143621 Nov 2011 WO
2012106266 Aug 2012 WO
2012154277 Nov 2012 WO
2012174109 Dec 2012 WO
2013119557 Aug 2013 WO
2013126446 Aug 2013 WO
2013187827 Dec 2013 WO
2014006403 Jan 2014 WO
2014029424 Feb 2014 WO
2014074417 May 2014 WO
2014081942 May 2014 WO
2014133617 Sep 2014 WO
2014165783 Oct 2014 WO
2015035393 Mar 2015 WO
15108913 Jul 2015 WO
2015168655 Nov 2015 WO
15164912 Nov 2015 WO
2016037127 Mar 2016 WO
Non-Patent Literature Citations (120)
Entry
EP 12782187.4 filed Sep. 10, 2013 European search report and written opinion dated Aug. 30, 2016.
EP 12782187.4 filed Sep. 10, 2013 European search report and written opinion dated Dec. 17, 2015.
EP 13876666.2 filed Sep. 7, 2015 Extended European Search Report dated Sep. 20, 2016.
International search report and written opinion dated Apr. 2, 2012 for PCT/US2012/023192.
JP 2016-107046 filed May 30, 2016 Office Action dated Jul. 28, 2016.
Office action dated Mar. 27, 2013 for U.S. Appl. No. 13/358,099.
PCT/US15/28950 filed May 1, 2015 International Search Report and Written Opinion dated Oct. 19, 2015.
PCT/US2015/048676 filed Sep. 4, 2015 International search report and written opinion dated Dec. 4, 2015.
U.S. Appl. No. 14/099,050, filed Dec. 6, 2013 Non-Final Office Action dated Jul. 19, 2016.
U.S. Appl. No. 14/167,149, filed Jan. 29, 2014 Notice of Allowance dated Jul. 6, 2016.
U.S. Appl. No. 14/174071, filed Feb. 6, 2014 Non-Final Office Action dated Jul. 29, 2016.
U.S. Appl. No. 14/174071, filed Feb. 6, 2014 Non-Final Office Action dated Mar. 31, 2016.
U.S. Appl. No. 14/192,541, filed Feb. 27, 2014 Non-Final Office Action dated Jul. 20, 2016.
U.S. Appl. No. 14/585,800, filed Dec. 30, 2014 Non-Final Office Action dated May 16, 2016.
U.S. Appl. No. 14/866,441, filed Sep. 25, 2015 Final Office Action dated Sep. 23, 2016.
JP 2013-510353 filed Oct. 31, 2012 Office Action dated Dec. 15, 2016.
PCT/US2016/032449 filed May 13, 2016 International Search Report and Written Opinion dated Oct. 5, 2016.
PCT/US2016/032534 filed May 13, 2016 International Search Report and Written Opinion dated Oct. 5, 2016.
U.S. Appl. No. 14/174071, filed Feb. 6, 2014 Final Office Action dated Dec. 2, 2016.
U.S. Appl. No. 14/192,541, filed Feb. 27, 2014 Notice of Allowance dated Dec. 6, 2016.
U.S. Appl. No. 14/250,093, filed Apr. 10, 2014 Non-Final Office Action dated Nov. 16, 2016.
U.S. Appl. No. 14/585,800, filed Dec. 30, 2014 Non-Final Office Action dated Nov. 29, 2016.
U.S. Appl. No. 14/866,441, filed Sep. 25, 2015 Advisory Action dated Dec. 22, 2016.
U.S. Appl. No. 14/866,738, filed Sep. 25, 2015 Non-Final Office Action dated Oct. 31, 2016.
CN 201510079782.7 filed Feb. 13, 2015 Office Action dated Dec. 30, 2016.
U.S. Appl. No. 14/099,050, filed Dec. 6, 2013 Final Office Action dated Jan. 30, 2017.
U.S. Appl. No. 14/192,541, filed Feb. 27, 2014 Notice of Corrected Allowability dated Mar. 8, 2017.
U.S. Appl. No. 14/250,093, filed Apr. 10, 2014 Final Office Action dated Mar. 9, 2017.
U.S. Appl. No. 14/750,658, filed Jun. 25, 2016 Non-Final Office Action dated Mar. 9, 2017.
U.S. Appl. No. 14/866,738, filed Sep. 25, 2015 Final Office Action dated Feb. 24, 2017.
CN 2012800008866.6 filed Aug. 14, 2013 Second Office Action dated Aug. 17, 2015.
European search report and opinion dated Dec. 1, 2010 for EP Application No. 10075422.5.
International search report and written opinion dated Jan. 16, 2009 for PCT/US2008/062954.
International search report and written opinion dated Apr. 14, 2014 for PCT Application No. US2014/013557.
Notice of allowance dated Jan. 16, 2014 for U.S. Appl. No. 12/598,053.
Notice of allowance dated Feb. 17, 2015 for U.S. Appl. No. 14/477,717.
Office action dated May 8, 2013 for U.S. Appl. No. 12/598,053.
Office action dated Aug. 28, 2013 for U.S. Appl. No. 12/598,053.
Office action dated Oct. 24, 2013 for U.S. Appl. No. 12/598,053.
Office action dated Dec. 4, 2012 for U.S. Appl. No. 12/598,053.
Office action dated Dec. 18, 2014 for U.S. Appl. No. 14/477,717.
Access Scientific, The PICC Wand® Product Data Sheet, Revision F, May 22, 2012.
Access Scientific, The Powerwand® Extended Dwell Catheter Brochure.
BD Angiocath™ Autoguard™ Shielded IV Catheter Brochure, © 2001.
BD Medical Systems, I.V. Catheter Family Brochure.
BD Saf-T-Intima™ Integrated Safety IV Catheter Brochure, © 2001.
Becton Dickinson, Insyte® AutoGuard™ Shielded I.V. Catheter Brochure, 1998.
CN 201180029526.7 filed Dec. 14, 2012 First Office Action dated Apr. 21, 2014.
CN 2012800008866.6 filed Aug. 14, 2013 First Office Action dated Dec. 31, 2014.
Hadaway, Lynn C., A Midline Alternative to Central and Peripheral Venous Access, Caring, Magazine, May 1990, pp. 45-50.
JP 2013-510353 filed Oct. 31, 2012 First Office Action dated Feb. 19, 2015.
Menlo Care, Landmark™ Aquavene® Catheters Brochure, 1992.
Menlo Care, Landmark® Midline Catheter Maintenance and Reference Guide.
Menlo Care, Landmark® Midline Catheters Brochure, 1991.
Menlo Care, Landmark® Venous Access Device Insertion Instructions.
Menlo Care, Publications on Aquavene® Technology, Aug. 1992.
PCT/US2011/036530 filed May 13, 2011 International Search Report dated Oct. 6, 2011.
PCT/US2011/036530 filed May 13, 2011 Written Opinion of the International Searching Authority dated Oct. 6, 2011.
PCT/US2012/026618 International Preliminary Report on Patentability dated Aug. 27, 2013.
PCT/US2012/026618 International Search Report and Written Opinion dated Jun. 25, 2012.
PCT/US2013/073577 filed Dec. 6, 2013 International Search Report and Written Opinion dated Feb. 24, 2014.
PR Newswire, Luther Medical Products, Inc. Receives Approval to Supply Improved Neonatal Product to Japan, Aug. 20, 1998.
Rasor, Julia S, Review of Catheter-related infection rates: comparison of conventional catheter materials with Aquavene®, JVAN vol. 1, No. 3, Spring 1991.
U.S. Appl. No. 13/107,781, filed May 13, 2011 Final Office Action dated Jul. 18, 2014.
U.S. Appl. No. 13/107,781, filed May 13, 2011 Non-Final Office Action dated Dec. 30, 2013.
U.S. Appl. No. 13/405,096, filed Feb. 24, 2012 Advisory Action dated Apr. 18, 2014.
U.S. Appl. No. 13/405,096, filed Feb. 24, 2012 Final Office Action dated Jan. 31, 2014.
U.S. Appl. No. 13/405,096, filed Feb. 24, 2012 Non-Final Office Action dated Aug. 20, 2013.
U.S. Appl. No. 13/405,096, filed Feb. 24, 2012 Non-Final Office Action dated Nov. 18, 2014.
U.S. Appl. No. 13/405,096, filed Feb. 24, 2012 Notice of Allowance dated Mar. 11, 2015.
U.S. Appl. No. 14/044,623, filed Oct. 2, 2013 Notice of Allowance dated Nov. 6, 2014.
Waltimire, B. and Rasor, J.S., Midline catheter: Virtually bloodless insertion technique and needle safety tube minimize potential for transmission of bloodborne disease. Sponsored by national Foundation for Infectious Diseases. 5th National forum on AIDS, Hepatitis, and other blood-borne diseases. Atlanta, GA, Mar. 1992.
CN 201280008866.6 filed Aug. 14, 2013 Third Office Action dated Jan. 25, 2016.
Cook Medical “Lunderquist Extra-Stiff wire guide” (2012).
Endovascular Today “Coiled Stainless Steel Guidewires” Buyer's Guide pp. 13-20, (2012).
European office action dated Apr. 21, 2008 for EP Application No. 06800027.2.
European office action dated Aug. 6, 2012 for EP Application No. 07783404.2.
European office action dated Oct. 5, 2010 for EP Application No. 07783404.2.
European search report and opinion dated Jul. 10, 2009 for EP Application No. 07783404.2.
International search report and written opinion dated Jun. 1, 2007 for PCT/US2006/026671.
International search report and written opinion dated Oct. 23, 2008 for PCT/US2007/068393.
JP 2013-510353 filed Oct. 31, 2012 Second Office Action dated Jan. 28, 2016.
Notice of allowance dated Jan. 29, 2014 for U.S. Appl. No. 12/307,519.
Notice of allowance dated Jun. 10, 2015 for U.S. Appl. No. 11/577,491.
Office action dated Mar. 10, 2011 for U.S. Appl. No. 12/307,519.
Office action dated Mar. 15, 2011 for U.S. Appl. No. 11/577,491.
Office action dated Aug. 2, 2010 for U.S. Appl. No. 11/577,491.
Office action dated Aug. 18, 2014 for U.S. Appl. No. 11/577,491.
Office action dated Oct. 25, 2010 for U.S. Appl. No. 12/307,519.
Office action dated Nov. 4, 2013 for U.S. Appl. No. 12/307,519.
Office action dated Mar. 12, 2015 for U.S. Appl. No. 11/577,491.
U.S. Appl. No. 14/099,050 filed Dec. 6, 2013 Non-Final Office Action dated Dec. 22, 2015.
U.S. Appl. No. 14/167,149 filed Jan. 29, 2014 Non-Final Office Action dated Oct. 21, 2015.
U.S. Appl. No. 14/174,071, filed Feb. 6, 2014 Restriction Requirement dated Dec. 7, 2015.
U.S. Appl. No. 14/585,800, filed Dec. 30, 2014 Non-Final Office Action dated Oct. 8, 2015.
U.S. Appl. No. 14/866,441, filed Sep. 25, 2015 Non-Final Office Action dated Mar. 14, 2016.
CA 2,799,360 filed May 13, 2011 Office Action dated Jun. 7, 2017.
CN 201480019467.9 filed Sep. 29, 2015 Office Action dated Apr. 6, 2017.
JP 2016-107046 filed May 30, 2016 Office Action dated Apr. 26, 2017.
U.S. Appl. No. 14/099,050, filed Dec. 6, 2013 Advisory Action dated Jun. 1, 2017.
U.S. Appl. No. 14/099,050, filed Dec. 6, 2013 Notice of Panel Decision dated Aug. 1, 2017.
U.S. Appl. No. 14/250,093, filed Apr. 10, 2014 Advisory Action dated May 19, 2017.
U.S. Appl. No. 14/250,093, filed Apr. 10, 2014 Panel Decision dated Jul. 14, 2017.
U.S. Appl. No. 14/585,800, filed Dec. 30, 2014 Notice of Allowance dated Jul. 3, 2017.
U.S. Appl. No. 14/750,658, filed Jun. 25, 2016 Notice of Allowance dated Jul. 20, 2017.
U.S. Appl. No. 14/866,441, filed Sep. 25, 2015 Non-Final Office Action dated Apr. 7, 2017.
U.S. Appl. No. 14/866,738, filed Sep. 25, 2015 Notice of Panel Decision dated Jun. 23, 2017.
U.S. Appl. No. 14/876,735, filed Oct. 6, 2015 Non-Final Office Action dated Mar. 30, 2017.
CN 201510079782.7 filed Feb. 13, 2015 Office Action dated Sep. 19, 2017.
JP 2015-560173 filed Aug. 28, 2015 Office Action dated Sep. 19, 2017.
U.S. Appl. No. 14/099,050, filed Dec. 6, 2013 Notice of Allowance dated Sep. 14, 2017.
U.S. Appl. No. 14/846,387, filed Sep. 4, 2015 Non-Final Office Action dated Sep. 22, 2017.
U.S. Appl. No. 29/536,043, filed Aug. 12, 2015 Non-Final Office Action dated Aug. 31, 2017.
U.S. Appl. No. 29/545,436, filed Nov. 12, 2015 Non-Final Office Action dated Sep. 12, 2017.
EP 11781384.0 filed Sep. 21, 2012 Extended European Search Report dated Oct. 31, 2017.
EP 15785819.2 filed Dec. 2, 2016 Extended European Search Report dated Dec. 4, 2017.
PCT/CN2017/075370 filed Mar. 1, 2017 International Search Report and Written Opinion dated Nov. 30, 2017.
U.S. Appl. No. 14/250,093, filed Apr. 10, 2014 Final Office Action dated Nov. 6, 2017.
U.S. Appl. No. 14/585,800, filed Dec. 30, 2014 Non-Final Office Action dated Nov. 3, 2017.
U.S. Appl. No. 14/866,738, filed Sep. 25, 2015 Non-Final Office Action dated Nov. 6, 2017.
Related Publications (1)
Number Date Country
20150231364 A1 Aug 2015 US
Provisional Applications (6)
Number Date Country
61988114 May 2014 US
61771703 Mar 2013 US
61385844 Sep 2010 US
61372050 Aug 2010 US
61345005 May 2010 US
61345022 May 2010 US
Continuation in Parts (2)
Number Date Country
Parent 14099050 Dec 2013 US
Child 14702580 US
Parent 13107781 May 2011 US
Child 14099050 US