US20060212009A1 - Drainage catheter hub with rotatable lever handle - Google Patents

Abstract

A drainage catheter hub having a rotatable lever handle adapted to secure a suture thread to maintain the anchor configuration of the distal end of the catheter to secure the position of the catheter within the patient's body. The rotatable lever handle has a released position for allowing movement of the suture and a secured position for preventing movement of the suture. A suture securement ridge adapted to secure the proximal portion of the suture that may otherwise remain loose during the procedure. The rotatable lever handle and associated rotatable barrel can be depressed relative to hub body in a locked configuration to prevent inadvertent rotational movement of the rotatable lever handle and a release slot or release button that can be actuated by the practitioner to allow for rotational movement of the rotatable lever handle.

Description

BACKGROUND OF THE INVENTION
• 1. The Field of the Invention
• The present invention relates to catheters. In more particular, the present invention relates to a drainage catheter hub having a rotatable lever handle adapted to secure a suture thread to maintain the anchor configuration of the distal end of the catheter to secure the position of the catheter within the patient's body.
• 2. The Relevant Technology
• One problem often encountered in modern medicine relates to volumes of fluids that collect in a patient's tissue, body cavities, or other positions within a patient's body that exceed normal volumes. Collected fluids can contribute to infection, exert harm pressure on the patient's organs, or otherwise impede with proper care and recovery of a patient. Drainage catheters have long been utilized to drain such excess volumes of fluids from a patient's body. Typically, the catheter is adapted to be introduced into the patient to the site where the excess fluid is accumulated. A plurality of drainage bores are positioned in the distal end of the catheter to allow passage of the fluids and any materials suspended in the fluids from the volume of fluid to the drainage bore of the catheter.
• The distal end of drainage catheters are typically adapted to form an anchor configuration to secure the drainage catheter at the site where excess fluid is accumulated. However, the tissue surrounding drainage sites often does not provide a solid or reliable substrate to maintain the position of the catheter. As a result, the anchor configuration of the catheter is typically formed in a relatively large pigtail type loop that provides a reliable anchor regardless of the characteristics of the surrounding tissue. The pigtail loop is formed by curling the tip of the catheter tube such that the tip of the catheter contacts a more proximal position on the catheter tube. This is accomplished utilizing a suture that is threaded between the proximal position and the tip of the catheter. When the suture is foreshortened, the tip of the catheter is securely positioned relative to the proximal position on the catheter tube. The portion of the distal end of the catheter tube between the tip of the catheter and the proximal position where the suture exits the catheter tube forms a resulting pig-tail type loop.
• The suture is adapted to run the length of the catheter and exit the catheter at the proximal end of the catheter tube. This allows the user to manipulate the suture to maintain or release the anchor configuration of the distal end of the catheter while the distal end of the catheter is positioned inside the patient. Once the anchor configuration of the distal end of the catheter has been established, the practitioner secures the suture to maintain the anchor configuration of the catheter. Otherwise, inadvertent movement of the patient could pull the suture resulting in separation between the tip of the catheter and the proximal position on the catheter tube where the tip of the catheter tube is secured by the suture. Conventionally, a practitioner wraps or ties the free portion of the suture around the proximal portion of the catheter or proximally positioned catheter hub. However, wrapping or tying of the suture can be somewhat inconvenient to perform and make it difficult to release, reposition the anchor, or withdraw the drainage catheter.
• A number of devices have been developed to attempt to secure the suture to maintain the anchor configuration of the distal end of the drainage catheter. One device provides a catheter hub adapted such that the suture is threaded between a proximal portion and a distal portion of the hub. To secure the suture, the proximal portion and the distal portion of the hub are pushed toward one another resulting in clamping of the suture between the proximal portion and the distal portion and minimizing movement of the suture. A number of deficiencies are presented by currently available suture securement devices. Many such devices are difficult to manipulate while manually maintaining tension on the suture thread. Additionally, such devices may provide ease in securing the suture, but are not as easily released to allow subsequent manipulation of the suture. Other devices are not intuitive to practitioners utilizing the devices requiring training or leading to improper usage of the device. Some devices do not effectively secure the suture leading to slippage or undesired placement of the distal end of the catheter within the patient.
BRIEF SUMMARY OF THE INVENTION
• The present invention relates to catheters. In more particular, the present invention relates to a drainage catheter hub having a rotatable lever handle adapted to secure a suture thread to maintain the anchor configuration of the distal end of the catheter to secure the position of the catheter within the patient's body. The rotatable lever handle has a released position for allowing movement of the suture and a secured position for preventing movement of the suture.
• A practitioner positions the rotatable lever handle in the release position for positioning the distal end of the catheter tube in a desired position within a patient's body, such as a volume of bodily fluid to be drained. In the released position, the distal end of the catheter can be configured in a linear or straightened configuration without being restrained by the suture. Once the distal end of the catheter tube is positioned in the desired position within the patient's body, the practitioner grasps the proximal end of the suture and pulls in a rearward direction. This foreshortens the suture, drawing the tip of the catheter tube to a more proximal position on the catheter tube and forming an anchor loop in the distal end of the catheter tube. The anchor loop prevents removal of the distal end of the catheter from the desired positioning while minimizing injury to the patient.
• Once the distal end of the catheter is formed into an anchor loop the user rotates the rotatable lever handle to the secured position to maintain the desired positioning of the distal end of the catheter tube within the patient. In the secured position, movement of the suture is prevented and the anchor loop configuration of the distal end of the catheter is maintained. This retains the desired positioning of the distal end of the catheter within the patient and minimizes inadvertent repositioning of the catheter during operation.
• According to one embodiment of the present invention, the catheter hub includes a suture securement ridge. The suture securement ridge is adapted to secure the proximal portion of the suture extending from the catheter hub that may otherwise remain loose during the procedure. After the practitioner has rotated the rotatable lever handle to a secured position, the practitioner can then wind the proximal portion of the suture around the suture securement ridge. The practitioner then rotates the rotatable lever handle an additional amount in the secured position such that the rotatable lever handle contacts the suture securement ridge. This prevents unraveling of the proximal portion of the suture wrapped about the suture securement ridge.
• Typically, once the drainage catheter is positioned at a desired location within the patient, the drainage catheter remains in the patient for a substantial period of time. According to one embodiment of the present invention, the rotatable lever handle and associated rotatable barrel can be depressed relative to hub body in a locked configuration. The locked configuration prevents inadvertent rotational movement of the rotatable lever handle. As a result, inadvertent movement of the rotatable lever handle by movement of the patient, contact of the handle with clothing, the patient's bed, or other surface is prevented. The catheter hub can also include a release slot or release button that can be actuated by the practitioner to release the locked configuration of the rotatable lever handle and allow for rotational movement of the rotatable lever handle. This allows the user to rotate the rotatable lever handle to the released position to manipulate the suture or withdraw the catheter.
• As will be appreciated by those skilled in the art, a variety of types and configurations of rotatable lever handles and suture securement mechanisms can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment the rotatable lever handle is positioned to the side of the rotatable barrel rather than around the outer circumference of the catheter hub. In another embodiment, the distal end of the catheter does not form a pigtail-type loop when in the anchor configuration. In another embodiment, the suture is utilized in connection with a release stylet such that the suture can be released by the rotatable lever handle or the stylet.
• These and other objects and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
• To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which 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. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
• FIG. 1 is a perspective view of a drainage catheter illustrating a catheter hub having a rotatable lever handle in a released position and the catheter tip being introduced into a body cavity of a patient.
• FIG. 2 is a perspective view of the drainage catheter ofFIG. 1 illustrating the distal end of the catheter forming an anchor loop and the rotatable lever handle in a secured position.
• FIG. 3 is a perspective view of the drainage catheter ofFIG. 1 illustrating a suture securement ridge of the catheter hub.
• FIG. 4 is a perspective view of the drainage catheter ofFIG. 1 illustrating the rotatable lever handle positioned adjacent the suture securement ridge to secure the proximal end of the suture.
• FIG. 5 is a perspective rear view of the drainage catheter ofFIG. 1 illustrating a release slot for moving the rotatable lever handle from a locked position to an unlocked position.
• FIG. 6 is an exploded view of the catheter hub ofFIG. 1 illustrating the the components of the hub.
• FIG. 7A is a close up perspective view of the rotatable lever handle and a rotatable barrel utilized in connection with the rotatable lever handle illustrating a cam surface of the rotatable barrel.
• FIG. 7B is a close-up end view of the rotatable barrel illustrating the relief of the cam surface relative to the outer circumference of the rotatable barrel.
• FIG. 8A is a cross-sectional side view of the catheter hub illustrating the manner in which the rotatable lever handle and the rotatable barrel allow movement of the suture when the rotatable lever handle is in a released position.
• FIG. 8B is a cross-sectional side view of the catheter hub illustrating the manner in which the rotatable lever handle and the rotatable barrel secure the suture when the rotatable lever handle is in a secured position.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The present invention relates to catheters. In more particular, the present invention relates to a drainage catheter hub having a rotatable lever handle adapted to secure a suture thread to maintain the anchor configuration of the distal end of the catheter to secure the position of the catheter within the patient's body. The rotatable lever handle has a released position for allowing movement of the suture and a secured position for preventing movement of the suture. According to one embodiment of the present invention, the catheter hub includes a suture securement ridge adapted to secure the proximal portion of the suture that may otherwise remain loose during the procedure. According to one embodiment of the present invention, the rotatable lever handle and associated rotatable barrel can be depressed relative to hub body in a locked configuration to prevent inadvertent rotational movement of the rotatable lever handle. The catheter hub can also include a release slot or release button that can be actuated by the practitioner to release the rotatable barrel to allow for rotational movement of the rotatable lever handle including rotating the rotatable lever handle to release the suture.
• FIG. 1 is a perspective view ofdrainage catheter10 illustrating acatheter hub14 having a rotatable lever handle28 according to one embodiment of the present invention.Drainage catheter10 is configured to be utilized for potentially prolonged periods to drain fluid from a patient.Catheter hub14 and rotatable lever handle28 provide a simple and effective mechanism to allow a user to selectively secure the anchor configuration of adistal end17 ofcatheter tube12 ofdrainage catheter10. Rotatable lever handle28 is adapted to secure asuture thread26 to maintain the anchor configuration of a distal end of the catheter tube to secure the position of the catheter tube within the patient's body. The rotatable lever handle28 has a released position for allowing movement of the suture and a secured position for preventing movement of the suture. Rotatable lever handle28 is shown in the released position inFIG. 1.
• In the illustrated embodiment,catheter hub14 is utilized in connection withcatheter tube12 ofdrainage catheter10.Catheter tube12 comprises an elongate tubular member having a drainage lumen for allowing the passage of fluid from the distal end ofcatheter tube12 tocatheter tube12. The configuration ofcatheter tube12 allows fluids to be drained from a patient18 tocatheter hub14.Catheter tube12 includes adistal end17. In the illustrated embodiment,distal end17 is shown being introduced into abody cavity20 ofpatient18.Distal end17 is positioned in a straightened configuration to facilitate the introduction ofdistal end17 into abody cavity20 ofpatient18.Distal end17 is introduced intobody cavity20 at a position configured to optimize the drainage of the volume offluid22 fromcavity20. A plurality of drainage bores24 are positioned in thedistal end17 ofcatheter tube12. The plurality of drainage bores permit the passage of fluids fromcavity20 to the lumen ofcatheter tube12. The fluids can then flow along the length ofcatheter tube12 andexit catheter hub14. The fluids can then be passed to a biological disposal container or other disposal reservoir.
• In the illustrated embodiment,suture26 is utilized in connection withcatheter tube12 andcatheter hub14.Suture26 is adapted to facilitate and maintain formation of an anchor loop configuration indistal end17 ofcatheter tube12.Suture26 runs fromcatheter hub14, along the length of catheter tube, exits acatheter tube12 at a suture exit bore27, and is then secured to tip16 ofcatheter tube12.Catheter hub14 allows securement or release ofsuture26. Rotatable lever handle28 is utilized to allow a user to either secure or releasesuture26 during the procedure being performed. In the illustrated embodiment, rotatable lever handle28 is positioned in a released position. When rotatable lever handle28 is in a released position, the practitioner can manipulatesuture26. This allows the user to straightendistal end17 ofcatheter tube12 during introduction ofdistal end17 intobody cavity20 ofpatient18. When rotatable lever handle28 is in a released position, the practitioner can also retractsuture26 to remove the slack insuture26 in the portion of suture adjacentdistal end17 ofcatheter tube12.
• As will be appreciated by those skilled in the art, a variety of types and configurations of drainage catheters can be utilized for draining bodily fluids from a patient without departing from the scope and spirit of the present invention. For example, in one embodiment the fluids to be drained exit from a portion of the drainage catheter other than the catheter hub. In another embodiment, the drainage catheter is adapted to be positioned adjacent an organ or in the vasculature of the patient. In another embodiment, the drainage catheter is introduced utilizing a guidewire or rigid stylet.
• FIG. 2 is a perspective view ofdrainage catheter10 ofFIG. 1 illustratingdistal end17 ofcatheter tube12 in an anchor loop configuration and rotatable lever handle28 in a secured position. In the illustrated embodiment,distal end17 ofcatheter tube12 is positioned in a desired location within volume offluid22 inbody cavity20. Whendistal end17 is positioned in a desired location within the volume offluid22, drainage of the volume offluid22 can be facilitated in an efficient and advantageous manner.
• To maintain the desired positioning ofdistal end17 within thebody cavity20 ofpatient18, the practitioner grasps the portion ofsuture26 extending proximally fromcatheter hub14. The user then pullssuture26 in a rearward direction. Pullingsuture26 in a rearward direction drawstip16 ofcatheter tube12 to a suture exit bore27. Suture exit bore27 is a point oncatheteter tube12 wheresuture26 exits the side wall ofcatheter tube12. Suture exit bore27 is positioned proximally tocatheter tip12. Assuture26 draws tip16 to suture exit bore27,distal end17 forms a pig-tail type anchor configuration. The anchor loop configuration indistal end17 ofcatheter tube12 maintains the position ofdistal end17 inbody cavity20 even where the wall of body cavity is insufficiently rigid to secure other catheter securement devices.
• Typically, oncedistal end17 ofcatheter tube12 is positioned in the anchor loop configuration, thedrainage catheter10 will remain positioned within the body of the patient for a considerable period of time to facilitate ongoing drainage of the volume of bodily fluid from the patient. Due to the considerable period oftime drainage catheter10 remains in operation, it is often desirable to maintain the anchor loop configuration ofdistal end17 ofcatheter tube12 for prolonged periods of time. To maintain the anchor loop configuration ofdistal end17 ofcatheter tube12, the user rotates rotatable lever handle28 in the direction of directional arrows2-2. Rotating rotatable lever handle28 in the direction of directional arrows2-2 moves rotatable lever handle28 from the released position of rotatable lever handle28 depicted inFIG. 1 to the secured position of rotatable lever handle28 depicted inFIG. 2. When rotatable lever handle28 is in the secured position, the components ofcatheter hub14secure suture26 maintaining the tension on the portion ofsuture26 positioned distally tocatheter hub14. As a result, the user can release the portion ofsuture26 extending proximally fromcatheter hub14 while maintaining the anchor loop configuration ofdistal end17 ofcatheter tube12.
• In the illustrated embodiment, drainage bores24 are positioned on the inside diameter ofdistal end17 whendistal end17 is positioned in the anchor loop configuration. When drainage bores24 are positioned on the inside diameter ofdistal end17, contact by the walls ofbody cavity20 ondistal end17 does not obstruct drainage of the volume of volume offluid22 frombody cavity20. This can be particularly helpful where the drainage ofbodily fluid22 causes collapse of the walls ofbody cavity20 during operation ofdrainage catheter10.
• FIG. 3 is a perspective view ofdrainage catheter10 illustrating the manner in which rotatable lever handle28 can secure the portion ofsuture26 extending proximally fromcatheter hub14. In the illustrated embodiment, the orientation of the perspective view has been reversed to more clearly illustrate the components ofcatheter hub14 that facilitate securing of the portion ofsuture26 extending proximally fromcatheter hub14. Once rotatable lever handle28 has been rotated to the locked position the tension ofsuture26 is secured. The practitioner can then release the portion ofsuture26 extending proximally fromcatheter hub14. However, in some circumstances, the length of the proximal portion ofsuture26 can result in tangling of the proximal portion ofsuture26 or other undesired interference withsuture26.
• In the illustrated embodiment, the proximal portion ofsuture26 has been wrapped around aprojection32 and asuture securement ridge34.Projection32 andsuture securement ridge34 are provided on the surface ofcatheter hub14 adjacent the connection withcatheter tube12.Projection32 andsecurement ridge34 provide a groove for maintaining the wrapped configuration of a loose portion ofsuture26.Projection32 andsecurement ridge34 provide a simple and effective mechanism for securing the loose end ofsuture26 when rotatable handle28 is in a secured position. When the user is ready to remove or reposition anchor loop configuration ofdistal end17 ofcatheter tube12, the user simply unwraps the suture fromprojection32 andsuture securement ridge34. In the illustrated embodiment, ahandle base29 of rotatable handle28 is shown. Handlebase29 provides a rotation axis about which handle rotates. Additionally, the portion ofhandle28 grasped by the practitioner is secured to the internal components ofcatheter hub14 utilizinghandle base29. Handlebase29 has an amount of separation from a front surface ofrotatable hub14.
• FIG. 4 is a perspective view ofdrainage catheter10 illustrating rotatable handle28 in a locked configuration while being positioned adjacentsuture securement ridge34. In the illustrated embodiment, when a user has wrapped the free proximal end ofsuture26 aboutprojection32 andsuture securement ridge34, the user can utilizerotatable handle28 to maintain the wrapped configuration ofsuture26. To utilizerotatable handle28 to maintain the wrapped configuration ofsuture26, the user rotatesrotatable handle28 an additional amount in the direction ofsuture securement ridge34. Rotatable handle28 is configured to contact or be positioned in close proximity with one or both ofprojection32 andsuture securement ridge34. In this position,rotatable handle28 covers the wrapped portion ofsuture26 preventing unraveling or slippage ofsuture26 fromsuture securement ridge34. When rotatable handle28 is rotated an additional amount to the position depicted inFIG. 4, rotatable handle28 is in the secured position.
• In an alternative embodiment of the present invention, the user can wrap the suture around another portion of the hub such as the catheter tube or the catheter tube engagement member positioned between the catheter tube and the body of the catheter hub. The tail of the suture is threaded between the suture securement ridge and the rotatable handle such that the tail of the suture is locked between the suture securement ridge and the rotatable handle when the rotatable handle is rotated to a locked position. In the embodiment, the rotatable handle is securely positioned adjacent the projection and in contact with the suture securement ridge and pushed into a locked configuration. To release the suture, the user moves the rotatable handle from a locked position, rotates the rotatable handle, and unwraps the suture from the catheter tube or catheter tube engagement member.
• In the illustrated embodiment, handlebase29 has been depressed such that it is flush withfront surface31 ofcatheter hub14. Whenhandle base29 is depressed,rotatable handle28 is locked in the secured position. When rotatable handle28 is locked in the secured position, rotational forces exerted onrotatable handle28 will not result in rotation ofrotatable handle28. This prevents inadvertent and undesired rotation ofrotatable handle28 whendrainage catheter10 is in operation. As a result, in the event that therotatable handle28 is inadvertently contacted by the patient's clothing, bed, chair or other surface therotatable handle28 will not be rotated to the released position. In a typical procedure, the practitioner depresseshandle base29 to a locked position when the anchor loop configuration ofdistal end17 of catheter tube is in a desired position,suture26 has been wrapped aboutsuture securement ridge34, and rotatable lever handle28 has been rotated to a position in which it covers the wrapped portion ofsuture26.
• As will be appreciated by those skilled in the art, a variety of types and configurations of catheter hubs can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment only one of a suture securement ridge and a projection are provided with the catheter hub. In another embodiment, one or both the suture securement ridge and projection are provided on the side of catheter hub opposite the catheter tube. In another embodiment, a locking member is provided to secure the suture relative to the securement ridge and the projection that is a separate and distinct component from the rotatable lever handle. In one embodiment, securement ridge and projection provide a groove, slot, taper, channel, or other relief surface to maintain the wrapped position of a free portion of suture. In another embodiment, a secondary mechanism independent of rotatable handle is utilized to lock the secured position of the rotatable handle.
• FIG. 5 is a rear-perspective view ofcatheter hub14 illustrating arelease slot38 for releasing the locked position ofrotatable handle28 allowing rotation ofrotatable lever handle28. In the illustrated embodiment, the volume offluid22 inbody cavity20 has been substantially drained. Additionally, the size ofbody cavity20 has greatly decreased due to the smaller amount of fluid exerting outward pressure on the walls ofbody cavity20. As previously discussed, the anchor loop configuration of thedistal end17 ofcatheter tube12 secures the position ofdistal end17 inbody cavity20. Additionally, when rotatable handle28 is in the secured position, the tension onsuture26 is maintained and thetip16 ofcatheter tube12 is secured adjacent suture exit bore27. Whentip16 ofcatheter tube12 is maintained adjacent suture exit bore27, the anchor loop configuration ofdistal end17 ofcatheter tube12 is also maintained.
• To release the anchor loop configuration ofdistal end17 ofcatheter tube12, the user must rotaterotatable handle28 to a released position allowing movement of the length ofsuture26. As discussed with reference toFIG. 4, whenhandle base29 is depressed to a locked position, the user is prevented from rotatingrotatable handle28. Arelease slot38 is provided on therear surface36 ofcatheter hub14. The user can utilizerelease slot38 to movehandle base29 from the locked position to a released position.
• Release slot38 allows a user to insert a pointed tool or other implement to movehandle base29 from a depressed locked position to a non-depressed release position. In the illustrated embodiment, a practitioner is inserting the tip of ahemostat40 intorelease slot38. The tip ofhemostat40 or the tool or implement being utilized by the practitioner contacts a surface interior to releaseslot38. The surface interior to releaseslot38 conveys forces from the hemostat to handlebase29 to movehandle base29 from the locked position to the released position. The user places a requisite amount of force onhemostat40 to force handle base to the released position. Once the requisite amount of force has been relayed from the surface interior to releaseslot38, handlebase29 is moved to the non-depressed release position and rotatable lever handle28 can be rotated. The components ofcatheter hub14 which operate in connection withhandle base29 andrelease slot38 to provide locking and release of rotatable lever handle28 will be discussed in greater detail with reference toFIGS. 6 and 7A.
• As will be appreciated by those skilled in the art, a variety of locking and release mechanisms can be utilized to selectively secure the secured position of the rotatable lever handle. In one embodiment, a button is provided that can be pushed in a first direction to lock the secured position of the rotatable lever handle and pushed in a second direction to allow rotational movement of the rotatable lever handle. In another embodiment, the user locks and unlocks the rotational position of the rotatable lever handle by exerting force directly on the rotatable lever handle. In one exemplary embodiment, the rotatable lever handle can be secured in more than one rotational position.
• FIG. 6 is an exploded view of acatheter hub14 illustrating the component of the catheter hub including therotatable barrel42 utilized in connection withrotatable handle28. In the illustrated embodiment,catheter hub14 comprises arotatable lever handle28, arotatable barrel42, ahub body44, abarrel seat46, asuture seal48, asuture seal seat50, asuture channel51, ahousing52, astylet54, and astylet release member56. Rotatable lever handle28 is integrally coupled torotatable barrel42 utilizinghandle base29.Rotatable barrel42 comprises a substantially cylindrically shaped member positioned perpendicularly to axis ofcatheter tube12.Rotatable barrel42 includes a cam surface (not shown) configured to selectively secure or release suture26 (seeFIG. 5) to secure the tension and/or positioning ofsuture26.Rotatable barrel42 and the cam surface will be discussed in greater detail with reference toFIG. 7A.
• Hub body44 comprises a securement mechanism for holding the internal components ofcatheter hub14.Hub body44 includes abody locking projection45.Body locking projection45 comprises, a square or rectangular extension of the inner wall ofhub body44. Body locking projection is sized to be positioned in a slot on the mating surface ofrotatable barrel42 whenhandle base29 is depressed into a locked position. The mating interaction with body locking projection and the slot in rotatable barrel prevent rotational movement ofrotatable barrel42 and thusrotatable lever handle28.
• Release slot38 is configured to cooperatively engage a projection ofrotatable barrel42 to prevent rotational movement ofrotatable barrel42. By utilizingrelease slot38 andbody locking projection45 with the slot and projection ofrotatable barrel42 provides two points of securement for minimizing rotation ofrotatable barrel42.Release slot38 allows a user to contact a rear surface or projection ofrotatable barrel42 to movehandle base29 to a non-depressed release position. When the tool or implement utilized by the user to contact the rear surface ofrotatable barrel42,rotatable barrel42 is slid in the direction away frombody locking projection45. This slides the slot on the rear side ofrotatable barrel42 from cooperative engagement withbody locking projection45 allowing rotational movement ofrotatable barrel42. The rear relief surfaces ofrotatable barrel42 utilized in connection withrelease slot38 andbody locking projection45 will be discussed in greater detail with reference toFIG. 7A.
• Barrel seat46 comprises a curved relief surface inhub body44.Barrel seat46 is sized to accommodaterotatable barrel42 to allow for simple and advantageous rotation ofrotatable barrel42 relative tohub body44.Barrel seat46 androtatable barrel42 are configured to cooperatively engage suture26 (not shown) to selectively securesuture26 based on the rotational position ofrotatable barrel42. In one embodiment of the present invention, the barrel and barrel seat are comprised of smooth surface non-compressible materials such as acetyl, Delrine®, polycarbonate, or similar smooth surface materials.Suture seal48 is configured to be positioned insuture seal seat50 adjacentrotatable barrel42.Suture seal48 provides a fluid tight seal withsuture26 to minimize the leakage of fluids from the main lumen of thecatheter hub14 assuture26 passes from the main lumen of thecatheter hub14 to thesuture seal seat50.Suture channel51 provides a passageway for suture26 (not shown) from the interior ofcatheter hub14 to the exterior ofcatheter hub14.
• Astylet54 andstylet release member56 are provided in connection withdrainage catheter10.Stylet54 andstylet release member56 are shown separated from one another for the sake of clarity. As will be appreciated by those skilled in the art, sytlet54 andstylet release member56 are typically integrally coupled such that movement ofstylet release member56 results in movement ofsytlet54.Stylet54 runs fromcatheter hub14 todistal end17 ofcatheter tube12.Stylet54 provides a securement apparatus forsuture26. A variety of types and configurations of mechanisms can be utilized for providing a stylet and suture combination with a drainage catheter. In the illustrated embodiment,stylet54 is positioned in a secondary lumen positioned in the sidewall ofcatheter tube12. By utilizing a secondary lumen, materials that are drained through the primary lumen ofcatheter tube12 do not interfere with proper operation ofstylet54.Stylet54 and the secondary lumen run fromcatheter hub14 to thetip16 of thecatheter tube12. A small bore at thetip16 ofcatheter tube12 exposesstylet54 and allowssuture26 to be wrapped aroundstylet54.
• When the practitioner is ready to removedrainage catheter10 from the patient, the practitioner disengagesstylet release member56 from its coupling withcatheter hub12. As the user pullsstylet release member56 in the rearward direction,stylet54 begins to be withdrawn from the secondary lumen ofcatheter tube12. Oncestylet54 is sufficiently withdrawn,stylet54 is also withdrawn from the position in which it is engaged bysuture26. Sincesuture26 is solely secured to the tip ofcatheter tube12 utilizingstylet54, removal ofstylet54 results in release ofsuture26. Whensuture26 is released, there is nothing to maintain the anchor configuration of distal end of the catheter tube. As a result, as the user begins to withdraw distal end of the catheter tube from the patient's body cavity, distal end of the catheter tube can straighten and easily exit the entry channel ofcatheter tube12.
• As will be appreciated by those skilled in the art, a variety of types and configurations of catheter hubs can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment the hub body includes two slots which cooperatively engage two projections of the rotatable barrel. In another embodiment, the rotatable barrel can be locked in a plurality of rotational positions. In another embodiment, the catheter hub does not include a stylet and stylet release member.
• FIGS. 7A andFIG. 7B illustraterotatable barrel42 and rotatable lever handle28 and acam surface58 associated therewith.Cam surface58 is utilized withrotatable barrel42 and rotatable lever handle28 to release and secure suture26 (not shown). In the illustrated embodiment, rotatable lever handle28 is secured torotatable barrel42 utilizinghandle base29. Rotatable lever handle28 can be grasped by a user and rotated to change the rotational position ofrotatable barrel42.Rotatable barrel42 is one example of a cam means.
• As will be appreciated by those skilled in the art, a variety of types and configurations of mechanisms for causing rotation of the rotatable barrel can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment a graspable projection that can be grasped by a user to rotate the rotatable barrel is provided on the face of handle base. In another embodiment, a tool is provided that cooperatively engages the rotatable barrel in a male/female relationship to allow a user to rotate the rotatable barrel.
• Cam surface58 includes asecurement portion60 and arelease portion62.Cam surface58 extends inwardly from the outside diameter of therotatable barrel42 such that therelease portion62 of thecam surface58 has a greater displacement from the inner contact surface of barrel seat46 (seeFIG. 6) than thesecurement portion60. When therotatable barrel42 is rotated such that the suture is located between therelease portion62 and the barrel seat (not shown) the suture can be moved by the user. When therotatable barrel42 is rotated such that the suture is located between thesecurement portion60 and the inner contact surface, the suture is cooperatively engaged between the barrel seat andsecurement portion60 to prevent movement of the suture. In the embodiment illustrated inFIG.7B securement portions60aand60bare positioned on both sides ofrelease portion62.Cam surface58 is one example of a cam means.
• In the illustrated embodiment,rotatable barrel42 includes abarrel locking projection64 and abarrel locking slot66.Barrel locking projection64 comprises a approximately rectangular shaped projection that extends from the rear surface ofrotatable barrel42.Barrel locking projection64 is sized to be inserted into release slot38 (seeFIG. 6) of hub body44 (seeFIG. 6) whenhandle base29 is depressed into a locking position. Whenhandle base29 is depressed into a locking position,barrel locking projection64 slides into the release slot of hub body effectively locking the rotational position ofrotatable barrel42. In the illustrated embodiment, lockingprojection64 and release slot38 (seeFIG. 6) of hub body44 (seeFIG. 6) secure the rotational position ofrotatable barrel42 such that the suture is secured bysecurement portion60 ofcam surface58. When a user desires to unlock the rotational position ofrotatable barrel42, the user inserts a tool or implement into release slot38 (seeFIG. 6) and pushes lockingprojection64 out of engagement withrelease slot38. This allows the user to rotaterotatable barrel42 utilizingrotatable lever handle28.
• Barrel locking slot66 comprises an approximately square shaped slot which extends inward from the rear surface ofrotatable barrel42.Barrel locking slot66 is sized to receive body locking projection45 (seeFIG. 6) of hub body44 (seeFIG. 6). Whenhandle base29 is depressed into a locking position,barrel locking slot66 slides over the body locking projection of the hub body effectively locking the rotational position of therotatable barrel42.Barrel locking slot66 and the body locking projection provide a secondary point of securement in addition tobarrel locking projection64 and the release slot to secure the rotational position ofrotatable barrel42. When the rotational position ofrotatable barrel42 is secured, the user is prevented from rotatingrotatable lever handle28. When a user pushes lockingprojection64 out of engagement withrelease slot38 utilizing a tool or other implement, the pushing force is relayed to the other components ofrotatable barrel42 slidingbarrel locking slot66 out of engagement with the body locking projection. The disengagement ofbarrel locking projection64 and release slot38 (seeFIG. 6) combined with the disengagement ofbarrel locking slot66 and body locking projection allow rotational movement ofrotatable barrel42. This allows the user to rotate rotatable lever handle28 to the released position allowing movement of the suture and anchor configuration of the distal end of the catheter tube.
• As will appreciated by those skilled in the art, a variety of types and configurations of locking mechanisms can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment a spring loaded rotatable barrel that maintains a locked position configured to prevent rotation of the barrel is provided. The user depresses the rotatable barrel to disengage the locked position and rotate the barrel. When the user releases the rotatable barrel subsequent to rotation, the spring loaded configuration of the barrel again locks the barrel securing the rotational position of the barrel. In another embodiment, a locking mechanism is provided having components that are separate from the rotatable barrel and the hub body. In another embodiment, the locking mechanism secures the rotational position of the rotatable barrel without depressing the handle base relative to the hub body. In another embodiment, the locking mechanism can secure a plurality of rotatable positions of the locking mechanism.
• As will be appreciated by those skilled in the art, a variety of types and configurations rotatable barrels and cam surfaces can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment, the entire circumference of the rotatable barrel comprises the cam surface and the cam surface is covered with alternating securement portions and release portions such that the rotatable barrel can be rotated continuously while providing alternating locking and releasing of the suture. In another embodiment, the suture is secured using a surface other than the cam surface. In yet another embodiment, a movable member other than the rotatable lever handle is provided to allow the user to selectively secure the suture.
• FIGS. 8A and 8B are cross-sectional views ofcatheter hub14 andcatheter tube12 depicting the manner in which rotatablebarrel42 securessuture26. In the illustrated embodiments,catheter tube12 is coupled tocatheter hub14 utilizing acatheter tube12 at the distal end ofcatheter hub14. The coupling ofcatheter hub14 tocatheter tube12 positions a lumen ofcatheter tube12 in fluid communication with amain lumen68 ofcatheter hub14. This allows bodily fluids to be drained from the patient, to the lumen ofcatheter tube12, and then tomain lumen68 ofcatheter hub14 before exitingdrainage catheter10.
• Suture26 is threaded along the length of the lumen ofcatheter tube12 and intomain lumen68. Assuture26 passes through the lumen ofcatheter tube12,suture26 extends throughmain lumen68.Suture26 exitsmain lumen68 throughsuture seal seat50. Fromsuture seal seat50,suture26 is threaded along the surface ofbarrel seat46 before exiting through suture channel51 (not shown).
• FIG. 8A illustratesrotatable barrel42 and rotatable lever handle28 in a released portion. Whenrotatable barrel42 is in the released position,release portion62 ofcam portion58 is positioned adjacent the portion ofsuture26 in contact withbarrel seat46. As previously discussed,cam surface58 extends inwardly from the outside diameter of therotatable barrel42 such that therelease portion62 of thecam surface58 has a greater displacement from the inner contact surface ofbarrel seat46 than thesecurement portion60. Due to the fact thatrotatable barrel42 is rotated such thatsuture26 is located between therelease portion62 and thebarrel seat46 thesuture26 can be moved by the user.
• FIG. 8B illustratesrotatable barrel42 and rotatable lever handle28 in a secured position. When therotatable barrel42 in the secured position thesecurement portion60 ofcam surface58 is positioned adjacent the portion ofsuture26 in contact withbarrel seat46. In this position, the suture is cooperatively engaged betweenbarrel seat46 andsecurement portion60 effectively preventing movement ofsuture26. The pathway ofsuture26 provides both an effective conduit forsuture26 to the tip ofcatheter tube12 while providing simple and effective manipulation ofsuture26. Additionally, the juxtaposition ofsuture26 and the components ofcatheter hub14 allow a user to simply and efficiently secure the position ofsuture26. By being able to secure and release the position ofsuture26 the user can secure or release the anchor configuration of the distal end of thecatheter tube12 to position or remove thecatheter tube12 from the patient.
• As will be appreciated by those skilled in the art, a variety of types and configurations of sutures can be utilized without deparating from the scope and spirit of the present invention. For example, in one embodiment the stylet does not extend to the tip of the catheter tube. In this embodiment, the suture extends to the tip of the catheter tube, exits the catheter tube, and is threaded back to the position on the catheter tube where the stylet terminates to form the anchor configuration of the distal end of the catheter tube. In another embodiment, the suture is threaded from the tip of the catheter tube to the catheter hub in a side lumen positioned in the wall of the catheter tube. In another embodiment, the suture wraps around a majority of the circumference of the rotatable barrel before exiting the catheter hub.
• The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (36)

1. A drainage catheter hub for use with a drainage catheter tube which provides a fluid pathway for draining bodily fluid from a cavity or tissue of a patient, the drainage catheter being configured such that a suture utilized in connection with the drainage catheter selectively secures the distal end of the catheter in an anchor configuration, the catheter hub configured to be coupled to the proximal end of the catheter tube, the drainage catheter hub comprising:

a seat having an inner contact surface and adapted to be in contact with a portion of the suture; and

a rotatable barrel adapted to be positioned in the seat, the rotatable barrel having an outside diameter adapted to conform to the inner contact surface of the seat to permit rotation of the rotatable barrel and a cam surface for selectively securing the suture based on the rotatable position of the rotatable barrel, wherein the cam surface comprises;

a release portion extending inwardly from the outside diameter of the rotatable barrel wherein the suture can be moved by the user when the rotational position of the rotatable barrel positions the suture between the release portion and the seat;

a securement portion wherein the suture is cooperatively engaged between the seat and the securement portion to prevent movement of the suture when the rotational position of the rotatable barrel positions the suture between the securement portion and the seat; and

a rotatable lever handle integrally coupled to the rotatable barrel to rotate the rotatable barrel between a rotational position in which the securement portion is positioned adjacent the suture to prevent movement of the suture and a rotational position in which the release portion is positioned adjacent the suture to allow movement of the suture.

2. The drainage catheter hub ofclaim 1, wherein the cam surface is tapered such that the release portion is positioned adjacent the securement portion.

3. The drainage catheter hub ofclaim 2, further comprising a second securement portion.

4. The drainage catheter hub ofclaim 3, wherein one securement portion is positioned adjacent the release portion on the side opposite the other securement portion.

5. The drainage catheter hub of claim.3, wherein the rotatable lever handle has a released position and a secured position.

6. The drainage catheter hub ofclaim 5, wherein the rotatable lever handle is configured to selectively secure the loose portion of the suture extending from the catheter hub.

7. The drainage catheter hub ofclaim 6, further comprising a suture securement member for allowing the user to wrap the loose portion of the suture extending from the catheter hub.

8. The drainage catheter hub ofclaim 6, wherein the rotatable lever handle is configured to contact the suture to secure the loose portion of the suture.

9. The drainage catheter ofclaim 8, futher comprising a locking mechanism for securing the rotational position of the rotatable lever handle.

10. A drainage catheter hub for use with a drainage catheter tube which provides a fluid pathway for draining bodily fluid from a cavity or tissue of a patient, the drainage catheter being configured such that a suture utilized in connection with the drainage catheter selectively secures the proximal end of the catheter in an anchor configuration, the catheter hub configured to be coupled to the proximal end of the catheter tube, the drainage catheter hub comprising:

a hub body comprising a seat having an inner contact surface and adapted to be in contact with a portion of the suture while permitting a loose portion of the suture to extend therefrom such that it can be grasped by a user;

a rotatable barrel comprising a cam surface having a release portion and a securement portion, wherein the release portion extends inwardly from the outside diameter a sufficient amount to permit movement of the suture when the suture is positioned between the tapered camming surface and the seat and wherein the securement portion is positioned adjacent the seat for cooperatively clamping the suture when the suture is positioned between the securement portion and the seat; and

a rotatable lever handle integrally coupled to the rotatable barrel to rotate c: w the rotatable barrel between a position in which the securement portion contacts the suture to prevent movement of the suture and a position in which the release portion is positioned adjacent the suture to allow movement of the suture, and wherein the rotatable lever handle selectively secures the loose portion of the suture extending from the catheter hub.

11. The hub body ofclaim 10, further comprising a suture securement member for allowing the user to wrap the loose portion of the suture extending from the catheter hub.

12. The hub body ofclaim 11, wherein the rotatable lever handle is configured to cover the suture securement member to prevent unraveling of the suture wrapped about the suture securement member.

13. The hub body ofclaim 12, wherein the rotatable lever handle is configured to contact the suture securement member.

14. The hub body ofclaim 11, wherein the suture securement member comprises a suture securement ridge.

15. The hub body ofclaim 11, wherein the suture securement member comprises a projection about which the suture can be wrapped.

16. The hub body ofclaim 11, wherein the suture securement member comprises a suture securement ridge and a projection.

17. The hub body ofclaim 16, wherein the suture securement ridge and the projection are positioned on the surface of the hub body adjacent the catheter tube.

18. The hub body ofclaim 16, wherein the suture securement ridge and the projection are positioned on the surface of the hub body adjacent the position where the suture exits the hub body.

19. The hub body ofclaim 11, wherein the suture securement member provides securement of the suture in addition to the securement provided by the rotational handle.

20. A drainage catheter hub for use with a drainage catheter tube which provides a fluid pathway for draining bodily fluid from a cavity or tissue of a patient, the drainage catheter being configured such that a suture utilized in connection with the drainage catheter selectively secures the proximal end of the catheter in an anchor configuration, the catheter hub configured to be coupled to the distal end of the catheter tube, the drainage catheter hub comprising:

a hub body comprising a seat having an inner contact surface and adapted to be in contact with a portion of the suture while permitting a loose portion of the suture to extend therefrom such that it can be grasped by a user;

a rotatable barrel comprising a cam surface having a release portion and a securement portion, wherein the release portion extends inwardly from the outside diameter a sufficient amount to permit movement of the suture when the suture is positioned between the tapered camming surface and the seat and wherein the securement portion is positioned adjacent the seat for cooperatively clamping the suture when the suture is positioned between the securement portion and the seat;

a rotatable lever handle integrally coupled to the rotatable barrel to rotate the rotatable barrel between a position in which the securement portion contacts the suture to prevent movement of the suture and a position in which the release portion is positioned adjacent the suture to allow movement of the suture, and wherein the rotatable lever handle; and

a locking mechanism provided in connection with the rotatable lever handle, the locking mechanism adapted to secure the rotational position of the rotatable lever handle.

21. The catheter hub ofclaim 20, wherein the locking mechanism is integrally coupled to the rotatable barrel and the hub body.

22. The catheter hub ofclaim 20, wherein the locking mechanism is a separate and distinct component from the rotatable barrel and the hub body.

23. The catheter hub ofclaim 21, wherein the locking mechanism secures the rotatable lever handle in a secured position to prevent movement of the suture.

24. The catheter hub ofclaim 20, further comprising a release mechanism for allowing movement of the rotatable lever handle subsequent to actuation of the locking mechanism.

25. The catheter hub ofclaim 24, wherein the locking mechanism comprises one or more slots on one of the rotatable barrel and the hub body and one or more projections one or more of the rotatable barrel and the hub body.

26. The catheter hub ofclaim 25, wherein the one or more slots cooperatively engages the one or more projections when the locking mechanism is actuated.

27. The catheter hub ofclaim 26, wherein the release mechanism comprises a release slot allowing the user to disengage the one or more projections and the one or more slots.

28. The catheter hub ofclaim 27, wherein the user urges the rotatable lever handle in a lateral direction to actuate the locking mechanism.

29. The catheter hub ofclaim 28, wherein the rotatable lever release slot allows a user to urge the rotatable barrel in a reverese lateral direction to release the locking mechanism.

30. A drainage catheter hub for use with a catheter tube adapted to be positioned in a body cavity or other position within a patient and utilizing a suture to maintain an anchor configuration in the distal end of the catheter tube, the drainage catheter hub comprising:

a hub body;

a cam means for selectively securing a suture, wherein the cam means is configured to rotate relative to the hub body and being adapted to secure the suture when in a first rotational position and being adapted to allow movement of the suture when in a second rotational position; and

a rotatable lever handle linked to the cam means for moving the rotatable barrel between the first rotational position and the second rotational position.

31. The drainage catheter hub ofclaim 30, wherein the cam means comprises a rotatable barrel.

32. The drainage catheter hub ofclaim 30, wherein the cam means comprises a cam surface.

33. The drainage catheter hub ofclaim 30, wherein the rotatable lever handle is positioned on a top side of the hub body.

34. The drainage catheter hub ofclaim 33, wherein the rotatable lever handle is positioned so as to rotate around the outer circumference of the catheter hub.

35. The drainage catheter hub ofclaim 30, wherein the rotatable lever handle is positioned on a lateral side of the hub body.

36. A drainage catheter for use in providing a fluid pathway for draining bodily fluid from a cavity or tissue of a patient, the drainage catheter being configured such that a suture utilized in connection with the drainage catheter selectively secures the distal end of the catheter in an anchor configuration, the drainage catheter comprising:

a catheter tube having a proximal end and a distal end, the distal end of the catheter tube being configured to be positioned in tissue, cavity, or other location within the body of the patient having an amount of fluid to be drained;

a suture running the length of at least a portion of the catheter tube and being secured to the distal end of the catheter tube to selectively maintain the anchor configuration of the distal end of the catheter;

a catheter hub coupled to the proximal end of the catheter tube, the catheter hub comprising:

a seat having an inner contact surface and adapted to be in contact with a portion of the suture;

a locking cam adapted to be positioned in the seat, the locking cam having an outside diameter adapted to conform to the inner contact surface of the seat and a tapered camming surface having a release portion and a securement portion, the tapered camming surface extending inwardly from the outside diameter such that the release portion of the tapered camming surface has a greater displacement from the inner contact surface of the seat than the securement portion, wherein the suture can be moved by the user when the locking cam is rotated such that the suture is located between the release portion and the inner contact surface of the seat and when the locking cam is rotated such that the suture is located between the securement portion and the inner contact surface, the suture is cooperatively engaged between the inner contact surface and the securement portion to prevent movement of the suture; and

a rotatable lever handle integrally coupled to the locking cam to rotate the locking cam between a position in which the securement portion contacts the suture to prevent movement of the suture and a position in which the release portion contacts the suture to allow movement of the suture.

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