Devices and systems for placing surgical drains and methods for using them

Abstract

Devices and methods are provided for placing a surgical drain that include a guide member including an elongate body and first and second arms extending from opposite ends of the body to define an open area therebetween within which tissue may be positioned, the first arm comprising a seat for receiving a hub on one end of surgical drain tubing, the second arm comprising a passage therethrough for guiding a trocar therethrough along an axis oriented towards the seat. When a trocar is inserted through the passage and through tissue in the open area, a tip of the trocar is directed towards the seat to engage the hub of the tubing and, when the trocar is thereafter withdrawn, the trocar pulls the hub and tubing back through the tissue and passage.

Description

DEVICES AND SYSTEMS FOR PLACING SURGICAL DRAINS AND METHODSFOR USING THEM5

[0001] RELATED APPLICATION DATAThe present application claims benefit of co-pending U.S. provisionalapplication Serial No. 63 / 737,666, filed December 21, 2024, the entire disclosure of whichis expressly incorporated by reference herein..10

[0002] TECHNICAL FIELDThe present application relates generally to medical devices and, moreparticularly, to devices for placing surgical drains and to systems and methods for usingsuch devices.15BACKGROUND

[0003] Drains are placed in many different surgeries and the majority of spinalsurgeries. Currently, drains are tunneled out of wounds by hand, which is unwieldy,imprecise, and risks injury to the surgeon and patient.Therefore, improved devices and methods for placing surgical drains would

[0004] 20be useful.SUMMARY

[0005] The present application relates generally to medical devices and, more25particularly, to devices for placing surgical drains and to systems and methods for usingsuch devices. In various examples, devices are provided that may be used to tunnel drainsout of surgical wounds. In one example, the device may include a hand held frame or guidemember to direct the trajectory and protect critical anatomical structures and a trocar that isable to create a tunnel through soft tissue, and capture and pull a silastic drain to the surface.30

[0006] In accordance with one example, a device is provided for placing a surgicaldrain that includes a guide member including an elongate body and first and second armsextending from opposite ends of the body to define an open area therebetween within whichtissue may be positioned, the first arm comprising a seat for receiving a hub on one end ofsurgical drain tubing, the second arm comprising a passage therethrough for guiding a trocartherethrough along an axis oriented towards the seat. When a trocar is inserted through thepassage and through tissue in the open area, a tip of the trocar is directed towards the seat toengage the hub of the tubing and, when the trocar is thereafter withdrawn, the trocar pullsthe hub and tubing back through the tissue and passage.5

[0007] In accordance with still another example, a system or kit is provided forplacing a surgical drain that includes a trocar comprising a shaft including a proximal endand a sharpened tip on a distal end for directing the shaft through tissue; a length of tubingincluding a hub on a first end of the tubing; and a guide member comprising an elongatebody and first and second arms extending from opposite ends of the body to define an open10area therebetween within which tissue may be positioned, the first arm comprising a seat forreceiving one or both of the hub and the first end of the tubing, the second arm comprising apassage aligned along an axis oriented towards the seat and sized for slidably receiving thetrocar shaft, wherein the distal end of the trocar shaft comprises a connector that engageswith the hub when the trocar is inserted through the passage and through tissue in the open15area to the hub to couple movement of the hub to the trocar such that, when the trocar isthereafter withdrawn, the trocar pulls the hub and tubing back through the tissue andpassage.

[0008] In accordance with yet another example, a method is provided forassembling a surgical device that includes providing a guide member comprising an20elongate body and first and second arms extending from opposite ends of the body to definean open area therebetween within which tissue may be positioned, a seat in the first arm,and a passage in the second arm; providing a length of tubing including a hub on a first endof the tubing; and receiving the hub in the seat in the first arm such that the tubing extendsfrom the first arm away from the open area and a pocket in the hub is oriented towards the25second arm such that, when a trocar is inserted through the passage and through tissue in theopen area, a tip of the trocar is directed towards the seat to enter the pocket and engage thehub to the trocar such that, when the trocar is thereafter withdrawn, the trocar pulls the huband tubing back through the tissue and passage.

[0009] In accordance with another example, a system or kit is provided for placing a30surgical drain that includes a trocar comprising a shaft including a sharpened tip fordirecting the shaft through soft tissue; a length of tubing including a hub on a first end of thetubing; and a guide member comprising an elongate body and first and second armsextending from opposite ends of the body to define an open area therebetween within whichtissue may be positioned, the first arm comprising a seat for receiving one or both of the huband the first end of the tubing, the second arm comprising a passage aligned along an axisoriented towards the seat and sized for slidably receiving the trocar shaft. One or moreconnectors are provided on the trocar and the hub that engage when the trocar is inserted5through the passage and through tissue in the open area to the hub to couple movement ofthe hub to the trocar such that, when the trocar is thereafter withdrawn, the trocar pulls thehub and tubing back through the tissue and passage.

[00010] In accordance with still another example, a method is provided for placing asurgical drain that includes providing a guide member comprising an elongate body and first10and second arms extending from opposite ends of the body to define an open areatherebetween; providing a length of tubing with a hub on a first end of the tubing positionedin a seat in the first arm; positioning the first arm within a surgical space within the patient'sbody and the second arm adjacent the patient's skin such that tissue is positioned within theopen area between the first and second arms; inserting a trocar through a passage in the15second arm and through the patient's skin and the tissue within the open area until a tip ofthe trocar engages the hub on the first end of the tubing within the seat to secure the trocarto the hub; and withdrawing the trocar back through the tissue and the passage, therebypulling the hub and tubing through the tissue and passage.

[00011] In accordance with another example, a system is provided for placing a20surgical drain that includes a trocar comprising a curved shaft including a proximal end anda distal end terminating in a sharpened tip for directing the shaft through tissue; a length oftubing including a first end coupled to the proximal end of the trocar; a guide membercomprising an elongate body and first and second arms extending from opposite ends of thebody, the first arm comprising a tubular member extending from the body and including a25lumen for receiving the trocar therethrough, the second arm comprising a first end pivotallycoupled to the body such that second arm rotates about an axis and a second end including afoot configured for placement against a patient's skin; a locking mechanism for preventingmovement of the second arm about the axis when the locking mechanism is engaged; andone or more connectors on the trocar and the foot that engage when the trocar is inserted30through the lumen of the tubular member and through tissue towards the foot to couplemovement of the trocar to the second arm such that, when the second arm is thereaftermoved, the trocar follows movement of the second arm.

[00012] In accordance with still another example, a method is provided for placing asurgical drain within a patient's body that includes providing a trocar comprising a curvedshaft including a proximal end and a distal end terminating in a sharpened tip and a lengthof tubing including a first end coupled to the proximal end of the trocar; providing a guide5member comprising an elongate body and first and second arms extending from oppositeends of the body, the first arm comprising a tubular guide extending from the body andincluding a lumen, the second arm comprising a first end pivotally coupled to the body anda second free end; positioning the first arm within a surgical space within the patient's bodywith the second arm outside the patient's body; manipulating the second arm to place a foot10on the second free end against the patient's skin; inserting the trocar through the lumen ofthe tubular guide and through the tissue and the patient's skin until the tip of the trocarengages a locking mechanism on the foot to secure the trocar to the foot; and manipulatingthe second arm to direct the foot away from the patient's skin, thereby pulling the trocar andtubing through the tissue.15

[00013] Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunction with the accompanyingdrawings.BRIEF DESCRIPTION OF THE DRAWINGS20

[00014] It is believed the present invention will be better understood from thefollowing description of certain examples taken in conjunction with the accompanyingdrawings, in which like reference numerals identify the same elements and in which:

[00015] FIG. 1 shows an example of a system for placing a surgical drain including atrocar, a guide member, and a length of tubing including a hub received in a seat of the25guide member.

[00016]

[00017] FIG. 2A is a side view of an exemplary guide member.FIG. 2B is a cross-section of the guide member of FIG. 2A.

[00018] FIG. 3A and 3B are perspective and side views, respectively, of a hub thatmay be provided on a first end of a length of tubing.30

[00019] FIG. 3C is a cross-sectional view of the hub of FIGS. 3A and 3B.

[00020] FIG. 4 is a cross-sectional detail of the hub of FIGS. 3A-3C with a trocar tipreceived within the hub.

[00021] FIGS. 5A-6C show an exemplary method for placing drain tubing using thesystem of FIG. 1.

[00022] FIGS. 7A and 7B are perspective and side views, respectively, of anotherexample of a system for placing a surgical drain.5

[00023] FIGS. 8A-8H show an exemplary method for placing drain tubing using thesystem of FIGS. 7A and 7B.

[00024] The drawings are not intended to be limiting in any way, and it iscontemplated that various examples of the invention may be carried out in a variety of otherways, including those not necessarily depicted in the drawings. The accompanying10drawings incorporated in and forming a part of the specification illustrate several aspects ofthe present invention, and together with the description serve to explain the principles of theinvention; it being understood, however, that this invention is not limited to the precisearrangements shown.15DETAILED DESCRIPTION

[00025] The following description of certain examples of the invention should not beused to limit the scope of the present invention. Other examples, features, aspects,embodiments, and advantages of the invention will become apparent to those skilled in theart from the following description, which is by way of illustration, one of the best modes20contemplated for carrying out the invention. As will be realized, the invention is capable ofother different and obvious aspects, all without departing from the invention. Accordingly,the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[00026] Before the examples are described, it is to be understood that the invention isnot limited to particular examples described, as such may, of course, vary. It is also to be25understood that the terminology used herein is for the purpose of describing particularexamples only, and is not intended to be limiting, since the scope of the present inventionwill be limited only by the appended claims.

[00027] Where a range of values is provided, it is understood that each interveningvalue, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise,30between the upper and lower limits of that range is also specifically disclosed. Each smallerrange between any stated value or intervening value in a stated range and any other stated orintervening value in that stated range is encompassed within the invention. The upper andlower limits of these smaller ranges may independently be included or excluded in therange, and each range where either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specifically excluded limit in thestated range. Where the stated range includes one or both of the limits, ranges excludingeither or both of those included limits are also included in the invention.5

[00028] Unless defined otherwise, all technical and scientific terms used herein havethe same meaning as commonly understood by one of ordinary skill in the art to which thisinvention belongs. Although any methods and materials similar or equivalent to thosedescribed herein can be used in the practice or testing of the present invention, somepotential and exemplary methods and materials are now described.10

[00029] It must be noted that as used herein and in the appended claims, the singularforms "a," "an,” and “the” include plural referents unless the context clearly dictatesotherwise. Thus, for example, reference to “a compound" includes a plurality of suchcompounds and reference to "the polymer" includes reference to one or more polymers andequivalents thereof known to those skilled in the art, and so forth.15

[00030] Certain ranges are presented herein with numerical values being preceded bythe term "about." The term "about" is used herein to provide literal support for the exactnumber that it precedes, as well as a number that is near to or approximately the numberthat the term precedes. In determining whether a number is near to or approximately aspecifically recited number, the near or approximating unrecited number may be a number20which, in the context in which it is presented, provides the substantial equivalent of thespecifically recited number.

[00031] The term "substantially" is used throughout this document to indicatevariations in the thus qualified terms. These variations are variations that do not materiallyaffect the manner in which the invention works and can be due, for example, to uncertainty25in manufacturing processes or to small deviations from a nominal value or ideal shape thatdo not cause significant changes to the invention. Also, the terminology “proximal" and"distal" refers to a position relative to an operator using the present disclosure on a patient.For example, distal elements are closer to an intervention site, e.g., a patient's skin, andproximal elements are closer to an operator, for example, a doctor or other caregiver using30the devices herein.

[00032] Turning to the drawings, FIG. 1 shows an example of an apparatus, system,or kit 10 for placing a surgical drain within a patient's body. Generally, the system 10includes a guide member or frame 20 and a trocar 40 for introducing a length of tubing 50,e.g., a length of silastic or other flexible tubing, using a hub or locking clip 60 on a first end52 of the tubing 50 to tunnel and / or otherwise position the tubing 50 between a surgical siteand the patient's skin after a surgical procedure.

[00033] As shown, the trocar 40 includes a substantially straight elongate shaft 425including a proximal end 44 with a handle 45, and a distal end 46 terminating in asharpened tip 47 for directing the shaft 42 through tissue, similar to conventional trocars.The trocar shaft 42 may be formed from substantially rigid material, e.g., metal such asstainless steel, plastic or composite materials, having a substantially uniform diameterbetween the proximal and distal ends 44, 46. In addition, in the example shown, the handle1045 is a T-shaped member permanently attached to the proximal end 44 of the shaft 42, e.g.,by one or more of mating connectors, interference fit, bonding with adhesives, and the like,to facilitate manipulation of the trocar 40, particularly for advancing the tip 47 and shaft 42through tissue, e.g., as described elsewhere herein.

[00034] Unlike conventional trocars, the trocar 40 includes a connector adjacent the15tip 47, e.g., an annular groove 48 as shown in FIGS. 4 and 5C. In the example shown, thegroove 48 includes a tapered proximal edge 48a and a blunt distal edge 48b to facilitateinserting the tip 47 into the hub 60 and prevent subsequent removal, as described furtherelsewhere herein. Optionally, the tip 47 may have a proximal smaller diameter than thedistal end 46 of the shaft 42 proximal to the annular groove 48 or, alternatively, the tip 4720may be the same diameter of the shaft 42 before tapering to the pointed tip.

[00035] With additional reference to FIGS. 2A and 2B, the guide member 20includes an elongate body or frame 22 with first and second arms 24, 26 extending fromopposite ends of the body 22 to define an open area 28 therebetween within which tissuemay be positioned, e.g., during a surgical procedure in which a surgical drain is needed.25The guide member 20 may also include a handle 23 on the elongate body 22, e.g., closer tothe second arm 26, to facilitate manipulating the guide member 20, particularly forpositioning and holding the second arm 26 against a patient's skin while the trocar 40 isintroduced, as described further elsewhere herein.

[00036] The guide member 20 may be formed from substantially rigid material such30that the arms 24, 26 do not move substantially relative to one another during use of theguide member 20. For example, the guide member 20 may be formed from metal, plastic,or composite material, e.g., by one or more of molding, casting, 3D printing, machining,laser cutting, and the like. In the example shown, the elongate body 22, handle 23, andarms 24, 26 lie within a common plane and have a curved shape, e.g., a generally "C" or"U" shape within the plane.

[00037] The first arm 24 includes a seat 30 for receiving surgical tubing, e.g., sized toreceive the hub 60 on the first end of the tubing 50 shown in FIG. 1. In one example, the5seat 30 may be an enclosed cylindrical opening extending through the first arm 24 and sizedto receive the first end 52 of the tubing 50 and the hub 60 therein, e.g., such that the hub 60is oriented towards the second arm 26.

[00038] Optionally, the seat 30 may include a step-down therein to prevent the hub60 from passing entirely through the seat 30. In this example, during assembly or10preparation of the guide member 20, a second end 54 of the tubing 50 is inserted into theseat 30 from the open area side of the first arm 24, and the tubing 50 is fed through the seat30 until the hub 60 is received in the seat 30, e.g., as shown in FIG. 5C, thereby preventingfurther movement of the hub 60 through the seat 30. Alternatively, the seat 30 may includean open groove (not shown) in the first arm 24, e.g., having a "C" shaped cross-section,15which allows the tubing 50 and / or hub 60 to be snapped sideways into the groove from theside of the first arm 24, thereby securing the hub 60 oriented towards the second arm 26.

[00039] The second arm 26 includes a passage 32 therethrough for guiding the trocar40 therethrough along an axis 34. The passage 32 may be sized to slidably receive the shaft42 of the trocar 40, e.g., having a diameter slightly larger than the outer diameter of the20shaft 42 to allow the trocar 40 to be advanced through the passag32 with minimal lateralmovement. As shown, the axis 34 extends across the open area 28 between the arms 24, 26,i.e., such that the axis 34 is oriented towards the seat 30. For example, with the hub 60 fullyreceived within the seat 30, the hub 60 is aligned along the axis 34. Consequently, when thetrocar shaft 42 is inserted through the passage 32 and across the open area 28 along the axis2534, the tip 47 of the trocar 40 is directed towards the seat 30, e.g., to engage the hub 60 ofthe tubing 50, as described further elsewhere herein.

[00040] Optionally, multiple guide members or frames may be provided to a surgeonor other user that have different dimensions. For example, a plurality of guide membersmay be provided that include different distances between the first and second arms, e.g.,30such that a guide member may be selected based on the relative dimensions of the patient,e.g., the distance between the surgical space and skin location where the drain is beingplaced. In this option, a plurality of corresponding trocars may be provided, e.g., withdifferent lengths based on the distances between the arms in the corresponding guidemembers.

[00041] Optionally, a guide member or sleeve 27 may be provided in the passage 32.The sleeve 27 may be removable or permanently received in the passage 32. For example,5during initial manipulation of the guide member 20 and trocar 40, the trocar tip 47 may beinserted partially into the passage 32 to reduce the risk of contact with the tip 47 duringmanipulation of the guide member 20. In this option, the sleeve 27 may be sized to slidablyreceive the shaft 42 with minimal lateral movement to ensure the shaft 42 is directed acrossthe open area 28 towards the hub 60.10

[00042] Turning to FIGS. 3A-3C, the hub or locking member 60 generally includes aconnector portion 62 that secures the hub 60 to the first end 52 of the tubing 50 and a headportion 64 that includes a pocket 66 for receiving the tip 47 of the trocar 40, e.g., as shownin FIG. 4. In the example shown, the connector portion 62 may include a ribbed nipplesized to be received within the first end 52 of tubing 50. In addition or alternatively, the15connector portion may include additional features, e.g., external threads (not shown) thatmay be threaded into the first end 52 of the tubing 50 or internal threads that may threadedover the first end 52 of the tubing 50 (also not shown). In these alternatives, the first end 52of the tubing 50 may include threads to interact with the threads on the connector portion 62or, if the threads on the connector portion 62 are sufficiently sharp, the threads may bethreaded directly into the wall of the tubing 50.20

[00043] The hub 60 may be attached to the tubing 50 during a surgical procedure,e.g., by selecting a hub 60 and inserting or otherwise connecting the hub 60 to the first end52 of a desired length of tubing 50. For example, the tubing 50 may be provided in adesired length for the procedure, or a desired length may be cut from a longer spool or other25source of tubing. The ribbed nipple may then be inserted into the first end 52 of the tubing50, with the ribs preventing subsequent removal. Alternatively, the connector portion 62may be threaded or over or into the first end 52 of the tubing 50, thereby securing the hub60 to the tubing 50.

[00044] The hub 60 may then be received in the seat 30, e.g., immediately before30using the guide member 20 to place the tubing 50. Optionally, a plurality of different sizehubs and / or tubing lengths may be provided such that a surgeon or other user may select adesired combination of hub and tubing for the particular anatomy encountered during anindividual procedure. Thus, the user may select a hub, connected to a desired length oftubing, and insert the tubing and hub into the seat. Alternatively, the hub 60 and tubing 50may be received in the seat 30 before the procedure, e.g., during manufacturing or otherassembly. In this alternative, the hub 60 may be removable or permanently attached to thefirst end 52 of the tubing 50, e.g. by the connector portion 62 and / or by one or more5bonding with adhesive, fusing, sonic welding, and the like.

[00045] As best seen in FIG. 3C, the head portion 64 of the hub 60 includes anopening 68 opposite the connector portion 62 communicating with the pocket 66 throughwhich the trocar tip 47 may be introduced into the pocket 66. In the example shown, theopening 68 includes a tapered outer surface 68a and a blunt inner surface 68b, which may10facilitate inserting the trocar tip 47 into the pocket 66. For example, the tapered outersurface 68a may allow the trocar tip 47 to slide through the opening 68 into the pocket 66until the groove 48 is received in the opening 68. The blunt inner surface 68b of theopening 68 and the blunt distal edge 48b of the trocar groove 48 may then engage to preventthe trocar tip 47 from being withdrawn back through the opening 68, thereby coupling15subsequent movement of the hub 60 to the trocar 40, as described further elsewhere herein.

[00046] As best seen in FIGS. 3A and 3B, the head portion 64 of the hub 60 includesa longitudinal slot 65 extending axially along the length of the pocket 66, e.g., between theopening 68 and a base from which the connector portion 62 extends. The slot 65 may beprovided desired flexibility to allow the opening 68 to expand when the trocar tip 47 is20inserted through the opening 68 into the pocket 66, and then resiliently compress again toengage the connectors (the blunt inner surface 68b of the opening 68 and blunt distal edge48b of the trocar groove 48), e.g., as shown in FIG. 4. In addition or alternatively, thematerial of the hub 60 surrounding the opening 68 may be sufficiently flexible to expand,e.g., even if the opening 68 is fully enclosed (i.e., the head portion 64 is an enclosed tubular25body, not shown), to allow the trocar tip 47 to pass through the opening 68 and engage theconnectors.

[00047] Turning to FIGS. 5A-6C, an exemplary method is shown for using thesystem 10 to deliver the tubing 50 to place a surgical drain within a patient's body. It willbe appreciated that the system 10 may be used for placing drains in a variety of anatomical30locations and / or during various surgeries in which it is desired to place a drain. Initially, asshown in FIG. 1, the guide member 20 may be provided with the first end 52 of the tubing50 and hub 60 received in the seat 30.

[00048] For example, a surgeon, medical personnel assisting the surgeon, or otheruser may select a length of tubing 50, connect the hub 60 to the first end 52, and thenbackload the second end 54 of the tubing 50 through the seat 30 until the hub 60 is receivedin the seat 30. Optionally, multiple hubs may be provided that include different size5connector portions, if desired, e.g., such that the user may select a desired hub to connect toa desired size of tubing that is to be implanted. In addition or alternatively, multipledifferent lengths of tubing may be provided such that the user may select a desired lengthand connect the hub 60 to the first end 52 of the tubing 50. Alternatively, the hub 60 mayalready be attached to the tubing 50, e.g., during manufacturing (or a set of preassembled10hubs and tubing may be provided having different lengths or other dimensions), such that ahub / tubing combination may be selected and loaded into the seat 30. In a furtheralternative, the hub 60 and tubing 50 may be provided already loaded into the seat 30, e.g.,during manufacturing, such that the user begins the procedure with the guide member 20and tubing 60 preassembled. Optionally, in this alternative, multiple preassembled guide15members and tubing sets may be provided, if desired, to allow the user to select anappropriate combination for a particular procedure, e.g., based on the individual patientanatomy encountered.

[00049] With the hub 60 and tubing 50 loaded into the seat 30, the first arm 24 maybe positioned within a surgical space within the patient's body, e.g., through a surgical20opening, and the second arm 26 may be positioned adjacent the patient's skin, e.g., above orotherwise adjacent the surgical space, such that tissue is positioned within the open area 28between the first and second arms 24, 26. For example, the surgeon may hold the handle 23to place the second arm 26 against or otherwise adjacent the patient's skin above a selectedpath for drain placement.25

[00050] Once the second arm 26 is positioned at the desired location, the trocar 40may be inserted through the passage 32 and the tip 47 advanced into the patient's skin andthrough intervening tissue until the tip 47 enters the surgical space. With the passage 32and seat 30 aligned along axis 34, as the trocar 40 passes through the tissue, the tip 47travels along the axis 34 until the tip 47 reaches the hub 60, whereupon the tip 47 may be30advanced (e.g., as one continues motion) through the opening 68 into the pocket 66 of thehub 60, e.g., as shown in FIGS. 5A-5C. As explained above, once the trocar tip 47 passesthrough the opening 68 into the pocket 66, the blunt distal edge 48b of the trocar groove 48may engage the blunt inner surface 68b of the hub 60, thereby preventing the tip 47 frombeing subsequently removed from the pocket 66.

[00051] Turning to FIGS. 6A-6C, the trocar 40 may then be withdrawn back throughthe tissue and passage 32, thereby pulling the hub 60 and tubing 50 through the tissue and5passage 32 until the hub 60 and first end 52 are outside the patient's body. The tubing 50may slide freely through the seat 30, e.g., until the second end 54 of the tubing 50 passesthrough the seat 30. The second end 54 may be positioned as desired within the surgicalspace, and any desired excess tubing outside the patient's body may be cut or otherwiseremoved, thereby providing a drain extending from the patient's skin into the surgical space.10The resulting drain may be secured as desired and the surgical procedure completed usingconventional methods.

[00052] Turning to FIGS. 7A and 7B, another example of an apparatus 110 forplacing a drain is shown that includes a guide member or frame 120, a trocar 140, and alength of tubing 150. In this example, the guide member 120 includes an elongate body 12215including a first fixed arm or guide 124 and a second movable arm 126 on opposite ends ofthe body 122.

[00053] As shown, the first arm 124 may provide a tubular guide extending from thebody 122, e.g., orthogonal to a length of the body 122, and including a lumen 124atherethrough sized to receive the trocar 140. The lumen 124a communicates with a passage20or opening 123 extending through the body 122, thereby providing a guide path for thetrocar 140 during advancement, as described further below. In the example shown, thetubular guide 124 has a curved shape, e.g., with a radius of curvature similar to the trocar140. The tubular guide / first arm 124 may be permanently attached to the first end 122a ofthe body 122, e.g., by one or more of cooperating connectors, interference fit, bonding with25adhesive, sonic welding, fusing, and the like such that the tubular guide 124 remains fixedto the first end 122a of the body 122.

[00054] The trocar 140 includes a shaft 142 including a proximal end 144, optionallywith a handle or hub 145, and a distal end 146 terminating in a sharpened tip 147. A lengthof tubing 150 extends from the proximal end 144, e.g., having an outer diameter30substantially the same as the outer diameter of the shaft 142. For example, a first end 152of the tubing may be attached to the proximal end 144 of the shaft 142, e.g., by one or moreof bonding with adhesive, fusing, sonic welding, and the like, such that the first end 152 ofthe tubing 150 is aligned with the shaft 142 and the second end 154 (not shown, e.g., FIGS.8G and 8H) is free.

[00055] The shaft 142 may be formed from substantially rigid material, e.g., metalsuch as stainless steel, plastic, or composite material, having a fixed radius of curvature or5other arc shape, and the tubing 150 may be formed from flexible, biocompatible material,similar to the components of the device 10.

[00056] The handle or hub 145 may be removable from the trocar 140, e.g., such thatthe entire trocar 140 may be pulled through tissue along the tunnel path, as described furtherbelow. For example, the handle or hub 145 may include an actuator (not shown) to direct a10tab or other feature against the shaft 142 to secure the handle or hub 145 frictionally inplace. When desired, the actuator may be opened to release the feature and allow the handleor hub 145 to slide along the shaft 142. Alternatively, the handle or hub 145 may include aclamp (not shown) that may be opened and closed to releasably secure the handle or hub145 around the shaft 142.15

[00057] The trocar shaft 142 may have a desired arc length to facilitate advancing theshaft 142 through tissue, e.g., between about seventy and one hundred twenty degrees (70-120°), e.g., about ninety degrees (90°). The tubular guide 124 may have an arc lengthsubstantially shorter than the trocar shaft 142, e.g., not more than about between about thirtyand sixty degrees (30-60°) or about forty five degrees (45°). Optionally, multiple trocars20and guide members may be provided with different dimensions, e.g., such that a user mayselect an appropriate combination may be selected based on a patient's individual anatomy.In one example, a small guide may be provided that is configured to create a tunnel throughtissue about eight millimeters (80 mm) long, and a large guide may be provided that isconfigured to create a tunnel through tissue about one hundred thirty millimeters (130 mm)25long.

[00058] The movable arm 126 includes a first end 126a coupled to a second end 122bof the body 122 and a second, free end 126b including a foot 128 configured for placementagainst a patient's skin during use of the guide member 120. The first end 126a may bepivotally coupled to the second end 122b of the body 122 by a hinge or other mechanism30such that the movable arm 126 may pivot about an axis 126c. A locking mechanism 127may be provided to fix or limit movement of the movable arm 126 about the axis 126c. Forexample, the first end 126a may include a ratchet mechanism 127a, e.g., including aplurality of teeth or other locking elements, and a latch or other actuator 127b may beprovided on the body 122 adjacent the ratchet mechanism 127a, which may be manipulatedto selectively engage the latch 127b with one or more teeth of the ratchet mechanism 127a.For example, with the latch 127b disengaged, the movable arm 126 may be free to rotateabout the axis 126c; however, once the latch 127b is engaged with the ratchet mechanism5127a, the arm 126 is locked from subsequent movement until the latch 127b is disengaged.

[00059] In addition, the foot 128 and the trocar 140 may include one or moreconnectors for coupling the trocar 140 to the foot 128. For example, the trocar 140 mayinclude an annular groove 148 adjacent the tip 147, and the foot 128 may include a lockingmember 129 including one or more detents or other features therein (not shown) sized to10receive and engage the groove 148 when the tip 147 is directed towards the foot 128 (e.g.,similar to the hub 60 and trocar 40), as described further below. Alternatively, one or moredetents or other locking elements may be provided on the foot 128 itself, e.g., such that thelocking elements engage the groove 148 when the trocar tip 147 passes through the foot128.15

[00060] Turning to FIGS. 8A-8H, an exemplary method is shown for placing asurgical drain using the apparatus 110 within a patient's body 90. Initially, as shown inFIG. 8A, the guide member 120 is manipulated to position the tubular guide 124 within asurgical space 96, e.g., with the tubular guide 124 oriented towards a target tunnel path, andwith the movable arm 126 outside the surgical space 96, e.g., above the patient's skin 92.20Turning to FIG. 8B, the movable arm 126 may be manipulated to move the foot 128towards the patient's skin 92 above or otherwise adjacent the surgical space 96, i.e., on theopposite side of the target tunnel path, e.g., by rotating the movable arm 126 as representedby arrow 160 to place the foot 128 against the patient's skin 92. For example, with the latch127b disengaged from the ratchet mechanism 127a, the movable arm 126 may be positioned25as desired to place the foot 128 against the skin 92, whereupon the latch 127b may beengaged with one or more of the ratchets to prevent subsequent movement of the arm 126.Optionally, the foot 128 may be pivotably mounted on the movable arm 126 such that thefoot 128 may be seated properly against the patient's skin 92. The position of the movablearm 126 relative to the tubular guide 124 and the surgical space 96 may be selected as a30target path for the trocar and, consequently, a tunnel path for the tubing being placed toprovide the drain.

[00061] As shown in FIGS. 8B-8D, the trocar 140 may then be inserted into theopening 123 in the body 122 (FIG. 8B), through the lumen 124a of the tubular guide 124and then the tip 147 may be advanced through tissue 94 (FIG. 8C) until the tip 147 exits thepatient's skin 92 and encounters the foot 128 (FIG. 8D). Alternatively, the trocar 140 maybe provided partially inserted into the opening 123 during initial manipulation of the guidemember 120, e.g., with the tip 147 positioned within the lumen 124a to prevent the tip 1475from being exposed until the trocar 140 is advanced. As shown in FIG. 8D, as the trocar140 is advanced from the lumen 124a of the tubular guide 1240 and through the tissue 94and skin 92, the trocar 140 may pass through an opening in the foot 128 until the tip 147enters the locking member 129, e.g., such that the groove 148 adjacent the trocar tip 147 isengaged with the one or more detents or other connectors in the locking member 129.10

[00062] Turning to FIG. 8E, once the trocar 140 is locked to the foot 128, the latch127b may be disengaged from the ratchet mechanism 127a to allow the movable arm 126 tobe manipulated, e.g., to rotate the arm 126 about the axis 126c away from the skin 92. Forexample, the second arm 126 may be pulled upwardly away from the patient 90 to direct thefoot 128 away from the patient's skin 92, as represented by arrows 162 and 164 shown in15FIGS. 8F and 8G, thereby pulling the trocar 140 through the tissue tract or tunnel that hasbeen created by the trocar 140.

[00063] If the handle 145 is provided on the trocar 140, the handle 145 may beremoved from the shaft 142 before the second arm 126 is manipulated to allow the proximalend 144 of the trocar 140 to pass through the tubular guide 124 and tissue 94. Alternatively,20the handle 145 may be released to allow the handle 145 to slide freely along the trocar shaft142 as the shaft 142 enters the opening 123 and first arm 124, e.g., when the handle 145abuts the body 120.

[00064] As shown in FIGS. 8F and 8G, the movable arm 126 may be rotatedsufficiently to pull the entire trocar 140 through the tissue such that the tubing 150 coupled25to the proximal end 144 of the trocar 140 is pulled through the guide member 124, the tissueand skin. Once the first 152 is exposed from the patient's skin 92, the tubing 150 may becut or otherwise separated from the trocar 140, which may be disposed of. As shown inFIG. 8H, the tubing 150 may be pulled through the lumen 124a of the tubular guide torelease the tubing 150 from the guide member 120, which may then be disposed of, with the30second end 154 located within the surgical space 96. The tubing 150 may then bemanipulated as desired and / or any excess tubing may be cut or otherwise removed resultingin a surgical drain with the second 154 of the tubing 150 positioned within the surgicalspace 96 and the first end 152 outside the patient's skin 92, as shown in FIG. 8H. Thesurgical procedure may then be completed using conventional methods.

[00065] While the invention is susceptible to various modifications, and alternativeforms, specific examples thereof have been shown in the drawings and are herein described5in detail. It should be understood, however, that the invention is not to be limited to theparticular forms or methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

WE CLAIM:1.A device for placing a surgical drain, comprising:a guide member comprising an elongate body and first and second arms extendingfrom opposite ends of the body to define an open area therebetween within which tissuemay be positioned, the first arm comprising a seat for receiving a hub on one end of surgicaldrain tubing, the second arm comprising a passage therethrough for guiding a trocartherethrough along an axis oriented towards the seat,wherein, when a trocar is inserted through the passage and through tissue in the openarea, a tip of the trocar is directed towards the seat to engage the hub of the tubing and,when the trocar is thereafter withdrawn, the trocar pulls the hub and tubing back through thetissue and passage.2.The device of claim 1, wherein the elongate body and the first and secondarms lie within a common plane.

3. The device of claim 2, further comprising a handle on the elongate body tofacilitate manipulating the guide member.4.The device of claim 2, wherein the guide member has a curved shapebetween the first end, the elongate body, and the second end.5.The device of any one of claims 1-3, wherein the guide member has agenerally "C" or "U" shape between the first and second arms.

6. The device of any one of claims 1-4, wherein the seat comprises an enclosedpassage passing through the first arm.7.The device of claim 6, wherein the enclosed passage comprises a step-downto secure the hub within the enclosed passage to prevent the hub from being pulled throughthe seat.8.The device of any one of claims 1-4, wherein the seat comprises a "C"shaped groove into which the hub may be inserted.9The device of any one of claim 1-4, further comprising a sleeve in thepassage in the second arm for receiving the trocar tip.

10. A system for placing a surgical drain, comprising:a trocar comprising a shaft including a sharpened tip for directing the shaft throughtissue;a length of tubing including a hub on a first end of the tubing;a guide member comprising an elongate body and first and second arms extendingfrom opposite ends of the body to define an open area therebetween within which tissuemay be positioned, the first arm comprising a seat for receiving one or both of the hub andthe first end of the tubing, the second arm comprising a passage aligned along an axisoriented towards the seat and sized for slidably receiving the trocar shaft; andone or more connectors on the trocar and the hub that engage when the trocar isinserted through the passage and through tissue in the open area to the hub to couplemovement of the hub to the trocar such that, when the trocar is thereafter withdrawn, thetrocar pulls the hub and tubing back through the tissue and passage.11.The system of claim 10, wherein the hub comprises a connector portion thatsecures the hub to the first end of the tubing and a head portion comprising a pocket for atleast partially receiving the tip of the trocar.

12. The system of claim 11, wherein the one or more connectors comprise anannular recess on the trocar shaft adjacent the tip and one or more detents on the headportion that engage the annular recess when the tip of the trocar is received in the pocket.

13. The system of claim 12, wherein the head portion comprises a “C” shapedcross-section surrounding the pocket to accommodate inserting the tip of the trocar into thepocket.14.The system of claim 11, wherein the connector portion comprises a nippleextending from the head portion sized to be received within the first end of the tubing.15.A kit for placing a surgical drain, comprising:a trocar comprising a shaft including a proximal end and a sharpened tip on a distalend for directing the shaft through tissue;a length of tubing including a hub on a first end of the tubing; anda guide member comprising an elongate body and first and second arms extendingfrom opposite ends of the body to define an open area therebetween within which tissuemay be positioned, the first arm comprising a seat for receiving one or both of the hub andthe first end of the tubing, the second arm comprising a passage aligned along an axisoriented towards the seat and sized for slidably receiving the trocar shaft,wherein the distal end of the trocar shaft comprises a connector that engages withthe hub when the trocar is inserted through the passage and through tissue in the open areato the hub to couple movement of the hub to the trocar such that, when the trocar isthereafter withdrawn, the trocar pulls the hub and tubing back through the tissue andpassage.

16. The kit of claim 15, wherein the hub comprises a connector portion thatsecures the hub to the first end of the tubing and a head portion comprising a pocket for atleast partially receiving the tip of the trocar.17.The kit of claim 16, wherein the connector comprises an annular recess onthe trocar shaft adjacent the tip, and wherein the head portion comprises one or more detentsthat engage the annular recess when the tip of the trocar is received in the pocket.

18. The kit of claim 17, wherein the head portion comprises a "C" shaped cross-section surrounding the pocket to accommodate inserting the tip of the trocar into thepocket.

19. The kit of claim 16, wherein the connector portion comprises a nippleextending from the head portion sized to be received within the first end of the tubing.20.A method for assembling a surgical device, comprising:providing a guide member comprising an elongate body and first and second armsextending from opposite ends of the body to define an open area therebetween within whichtissue may be positioned, a seat in the first arm, and a passage in the second arm;providing a length of tubing including a hub on a first end of the tubing; andreceiving the hub in the seat in the first arm such that the tubing extends from thefirst arm away from the open area and a pocket in the hub is oriented towards the secondarm such that, when a trocar is inserted through the passage and through tissue in the openarea, a tip of the trocar is directed towards the seat to enter the pocket and engage the hub tothe trocar such that, when the trocar is thereafter withdrawn, the trocar pulls the hub andtubing back through the tissue and passage.

21. The method of claim 20, further comprising inserting a tip of a trocarpartially into the passage without extending from the second arm into the open area.22.The method of claim 20, wherein the hub comprises a connector portion thatsecures the hub to the first end of the tubing and a head portion comprising the pocket.23.The method of claim 22, further comprising an annular recess on the trocarshaft adjacent the tip and one or more detents on the head portion that engage the annularrecess when the tip of the trocar is received in the pocket.

24. The method of claim 23, wherein the head portion comprises a "C" shapedcross-section surrounding the pocket to accommodate inserting the tip of the trocar into thepocket.

25. The method of any one of claims 20-24, wherein providing the length oftubing comprises attaching the hub to the first end of the tubing.

26. The method of claim 25, wherein attaching the hub comprises inserting anipple extending from the hub into the first end of the tubing.27.The method of claim 25, wherein attaching the hub comprises threading thehub over or into the first end of the tubing.28.The method of claim 25, further comprising cutting the tubing from a longersource of tubing.29.The method of any one of claims 20-24, wherein receiving the hub comprisesinserting a second end of the tubing through the seat until the hub is received in the seat.

30. The method of any one of claims 20-24, wherein receiving the hub comprisessnapping the hub through a slot in the first arm to receive the hub in the seat.31.A system for placing a surgical drain, comprising:a trocar comprising a curved shaft including a proximal end and a distal endterminating in a sharpened tip for directing the shaft through tissue;a length of tubing including a first end coupled to the proximal end of the trocar;a guide member comprising an elongate body and first and second arms extendingfrom opposite ends of the body, the first arm comprising a tubular guide extending from thebody and including a lumen for receiving the trocar therethrough, the second armcomprising a first end pivotally coupled to the body such that the second arm rotates aboutan axis and a second including a foot configured for placement against a patient's skin;a locking mechanism for preventing movement of the second arm about the axiswhen the locking mechanism is engaged; andone or more connectors on the trocar and the foot that engage when the trocar isinserted through the lumen of the tubular member and through tissue towards the foot tocouple movement of the trocar to the second arm such that, when the second arm isthereafter moved, the trocar follows movement of the second arm.

32. The system of claim 31, wherein the tubular member has a curved shape foraccommodating receiving the trocar shaft through the lumen.33.The system of claim 32, wherein the tubular member and the trocar shafthave substantially the same radius of curvature.34.The system of any one of claims 31-33, wherein the locking mechanismcomprises a ratchet mechanism on the first end of the second arm and a latch on the bodythat is actuatable to engage one or more ratchet elements to prevent subsequent movementof the second arm until the latch is disengaged.

35. The system of any one of claims 31-33, wherein the second arm is curvedbetween the first and second ends.

36. The system of any one of claims 31-33, wherein the tubular guide has acurved shape defining a radius of curvature similar to the trocar.

37. The system of any one of claims 31-33, wherein the tubing has substantiallythe same outer diameter as the shaft such that the tubing follows the shaft through the tissuewhen the trocar and the foot are engaged and the second arm is directed away from thepatient to pull the trocar and tubing through the tissue.

38. The system of any one of claims 31-33, further comprising a handle on theproximal end of the trocar to facilitate manipulating the trocar.39.The system of claim 38, wherein the handle is removable from the proximalend of the trocar to allow the tubing to pass through the lumen of the tubular guide when thetrocar is pulled through the tissue.40.The system of claim 38, wherein the handle is releasable from the proximalend of the trocar such the handle may slide over the tubing to allow the tubing to passthrough the lumen of the tubular guide when the trocar is pulled through the tissue.41.A method for placing a surgical drain within a patient's body, comprising:providing a guide member comprising an elongate body and first and second armsextending from opposite ends of the body to define an open area therebetween;providing a length of tubing with a hub on a first end of the tubing positioned in aseat in the first arm;positioning the first arm within a surgical space within the patient's body and thesecond arm adjacent the patient's skin such that tissue is positioned within the open areabetween the first and second arms;inserting a trocar through a passage in the second arm and through the patient's skinand the tissue within the open area until a tip of the trocar engages the hub on the first endof the tubing within the seat to secure the trocar to the hub; andwithdrawing the trocar back through the tissue and the passage, thereby pulling thehub and tubing through the tissue and passage.

42. The method of claim 41, further comprising:positioning a second end of the tubing within the surgical space; andremoving excess length of the tubing between the first and second ends of the tubingto leave a portion of the tubing exposed through the patient's skin to provide the drain.

43. The method of claim 41, wherein providing the length of tubing comprisespositioning the first end of the tubing and hub within the seat.44.The method of claim 43, further comprising attaching the hub to the first endof the tubing before positioning the first end of the tubing and hub within the seat.

45. The method of claim 41, wherein the hub comprises a recess that the trocartip enters when the trocar is inserted and wherein the hub and the trocar comprisecooperating connectors that secure the trocar tip within the recess.

46. A method for placing a surgical drain within a patient's body, comprising:providing a trocar comprising a curved shaft including a proximal end and a distalend terminating in a sharpened tip and a length of tubing including a first end coupled to theproximal end of the trocar;providing a guide member comprising an elongate body and first and second armsextending from opposite ends of the body, the first arm comprising a tubular guideextending from the body and including a lumen, the second arm comprising a first endpivotally coupled to the body and a second free end;positioning the first arm within a surgical space within the patient's body with thesecond arm outside the patient's body;manipulating the second arm to place a foot on the second free end against thepatient's skin;inserting the trocar through the lumen of the tubular guide and through the tissue andthe patient's skin until the tip of the trocar engages a locking mechanism on the foot tosecure the trocar to the foot; andmanipulating the second arm to direct the foot away from the patient's skin, therebypulling the trocar and tubing through the tissue.46.The method of claim 45, further comprising:positioning a second end of the tubing within the surgical space; andremoving excess length of the tubing between the first and second ends of the tubingto leave a portion of the tubing exposed through the patient's skin to provide the drain.47.The method of claim 45, wherein the second arm is fixed relative to theelongate body by a locking mechanism when the first arm is positioned within the surgicalspace, and wherein manipulating the second arm comprises:releasing the locking mechanism;rotating the second arm relative to the elongate body to place the foot against thepatient's skin; andengaging the locking mechanism to fix the second arm with the foot against thepatient's skin.

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