Patent Publication Number: US-2022218963-A1

Title: Surgical drain removal device and methods for using same

Description:
RELATED APPLICATION 
     This application claims priority to U.S. Provisional Patent Application Ser. No. 63/136,489, filed Jan. 12, 2021, the disclosure of which is hereby incorporated by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The invention relates to surgical drains, and more particularly, to devices designed to facilitate a safe and effective removal of surgical drains from a patient&#39;s body, and methods for using same. 
     BACKGROUND OF THE INVENTION 
     Surgical drains are used frequently in operations to allow fluid to drain out of a patient&#39;s body. Typically, these drains are made from flexible tubing that collects in a receptacle. Such receptacles include a bulb collection receptacle (e.g., a JP drain) or an accordion collection receptacle (e.g., a Hemovac drain), as both illustrated in  FIG. 1 . Surgical drains are placed near the end of the operation, and, after placement, the wound is closed. 
     One significant risk of placing a surgical drain is that the surgeon can, inadvertently, suture the drain into the patient (i.e., the surgical opening in the patient&#39;s body). This becomes evident when the surgeon (or other medical/surgical personnel) tries to remove the drain at the bedside. There is resistance noted if the drain has been sewn into the patient. Pulling too hard on the sewn-in drain can result in breaking the drain tubing, which then results in a retained foreign body in the patient. When the drain is sewn into the patient, it is typically necessary for the surgeon to return the patient to the operating room, open the incision, cut the suture that is preventing the drain from being removed, and remove the drain. 
     SUMMARY OF THE INVENTION 
     The devices and methods of the present disclosure provides a safe and effective solution for percutaneously removing a surgical drain that is an inadvertently sewn (i.e., sutured) into a patient who has undergone an operation. 
     Various embodiments of a surgical drain removal device according to the present invention include a hollow cylindrical body with opposed first and second open ends, the first end including cutting means; wherein the first end and hollow cylindrical body are configured to fit over an end of a surgical drain; and wherein the cutting means are moveable to cut a suture securing the surgical drain in a patient. 
     According to another embodiment, a method for percutaneously removing a surgical drain sutured into a patient includes the steps of: (a) providing a surgical drain removal device including: a hollow cylindrical body with opposed first and second open ends, the first end including cutting means having at least one blunt edge on a first side and at least one sharp edge on a second side; wherein the first end and hollow cylindrical body are configured to fit over an end of a surgical drain; and wherein the cutting means are moveable to cut a suture securing the surgical drain in a patient; (b) fitting the first end and an adjacent portion of the hollow cylindrical body of the surgical drain removal device over the end of the surgical drain so that the cutting means is adjacent the patient&#39;s skin and the suture; (c) advancing the removal device towards the patient until the cutting means comes into contact with the patient&#39;s skin; (d) moving the first end and cutting means in a first direction so that the at least one blunt edge is moved into the patient skin without cutting into the patient skin, until resistance is met; (e) moving the first end and cutting means in a second direction opposite the first direction while applying tension so that the at least one sharp edge is advanced to cut through the suture securing the surgical drain within the patient; and (f) removing the surgical drain and suture from the patient. 
     According to a further embodiment, a kit for the percutaneous removal of a surgical drain that is sutured inside of a patient includes a plurality of surgical drain removal devices. Each surgical drain removal device includes a hollow cylindrical body with opposed first and second open ends, the first end including cutting means; wherein the first end and hollow cylindrical body are configured to fit over an end of a surgical drain; and wherein the cutting means are moveable to cut a suture securing the surgical drain in a patient. The plurality of surgical removal devices have different sizes to accommodate surgical drains of different sizes. 
     This Summary of the Invention is neither intended nor should it be construed as being representative of the full extent and scope of the present disclosure. The present disclosure is set forth in various levels of detail in the Summary of the Invention as well as in the attached drawings and the Detailed Description of the Invention, and no limitation as to the scope of the present disclosure is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary of the Invention. Additional aspects of the present disclosure will become more readily apparent from the Detailed Description, particularly when taken together with the drawings. 
     The above-described benefits, embodiments, and/or characterizations are not necessarily complete or exhaustive, and in particular, as to the patentable subject matter disclosed herein. Other benefits, embodiments, and/or characterizations of the present disclosure are possible utilizing, alone or in combination, as set forth above and/or described in the accompanying figures and/or in the description herein below. However, the Detailed Description of the Invention, the drawing figures, and the exemplary claim set forth herein, taken in conjunction with this Summary of the Invention, define the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Embodiments of the invention are further described but are in no way limited by the following illustrations. The accompanying figures, which are incorporated in and constitute a part of the specification, illustrate preferred embodiments of the invention and, together with the description, serve to explain the objects, advantages, and principles of the invention. Embodiments of the invention are in no way limited by the following figures: 
         FIG. 1  shows two types of surgical drain/receptacle assemblies; 
         FIG. 2  is a top perspective exploded view of a surgical drain and a surgical drain removal device according to a first embodiment of the present invention; 
         FIG. 3  is a top perspective exploded view of the surgical drain removal device of  FIG. 2  with a surgical drain extending from the body of a patient; 
         FIG. 4  is a top perspective view of the surgical drain removal device of  FIG. 2  initially engaging a surgical drain extending from the body of a patient; 
         FIG. 5  is a top perspective view of the surgical drain removal device of  FIG. 2  more extensively engaging a surgical drain extending from the body of a patient so as to cut a suture securing the surgical drain in the patient; 
         FIG. 6  is a detailed view of a portion of the surgical drain removal device of  FIG. 2 ; 
         FIG. 7  is a schematic view of a surgical drain removal device according to a second embodiment of the present invention; and 
         FIG. 8  is a schematic view of a surgical drain removal device according to a third embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Disclosed herein are devices for the percutaneous bedside removal of a surgical drain that is inadvertently sutured inside of a patient, thereby alleviating the need for the surgeon and patient to return to the operating room to remove the drain in a subsequent surgical procedure. 
     As illustrated in  FIGS. 2-6 , a first embodiment of a surgical drain removal device  10  of the present invention includes cutting means  12  and is sized to fit snugly over the open, distal end E of a standard surgical drain D. Cutting means  12  are moveable to cut a suture securing a surgical drain in a patient without injuring the patient, as further explained below. In the embodiment shown in  FIGS. 2-6 , cutting means  12  includes a crown reamer that is configured to cut a suture when moved in one direction, but not to cut a patient&#39;s skin when moved in another, opposite direction. In other embodiments, cutting means  12  includes other structures that are configured to cut suture when moved in one direction, but not to cut a patient&#39;s skin when moved in another, opposite direction (see  FIGS. 7 and 8 ). 
     In various embodiments, the surgical drain removal device  10  is configured (e.g., sized) to accommodate surgical drains of different sizes (i.e., diameters). Such sizes include, as non-limiting examples, surgical drain diameters of 3 mm, 4 mm, 5 mm, 6 mm, and 7 mm. In other words, a removal device  10  according to embodiments of the invention is configured to accommodate a surgical drain having a 3 mm diameter, a 4 mm diameter, a 5 mm diameter, a 6 mm diameter or a 7 mm diameter. Surgical drawings having other sizes/diameters are also contemplated, where the removal device  10  may be configured accordingly. 
     In various embodiments, a kit is provided that includes multiple removal devices with crown reamers having different sizes (i.e., diameters), to accommodate surgical drains of different sizes. Such sizes include, as non-limiting examples, surgical drain diameters of 3 mm, 4 mm, 5 mm, 6 mm, and 7 mm. 
     In one embodiment, the surgical drain removal device  10  is disposable. In various embodiments, the removal device is made of one or more biologically acceptable materials. Non-limiting examples of such materials include ceramics, plastics and metals. Such metals include, as non-limiting examples, stainless steel, titanium, tungsten carbide and metal alloys. 
     Referring again to  FIGS. 2-6 , the surgical drain removal device  10  includes a hollow cylindrical body  14  with opposed first and second ends,  16 ,  18 . The first end  16  includes the cutting means/crown reamer  12 , which has a plurality of protruding teeth  20 . As shown in  FIGS. 2 and 4-6 , each of the teeth  20  is formed to have a blunt, or first, edge  22  on a first side and a sharp, or second, edge  24  on a second side. The blunt edge  22  is configured to function as a leading edge and not cut a patient&#39;s skin, and the sharp edge  24  is configured to cut through a suture but not to cut the surgical drain D. The second end  18  of the removal device  10  has a smooth circular shape (i.e., without teeth or other cutting means). 
     The first end  16  and the hollow cylindrical body  14  (i.e., an adjacent portion thereof) are configured to fit over the open, distal end E and exterior portion (i.e., extending outside of a patient&#39;s body) D E  of a standard surgical drain D. Such a fit is snug and secure. In various embodiments, the fit between the first end  16  and hollow cylindrical body  14  and the open, distal end E is achieved by an interference fit, a friction fit or any other type of fitting that provides a snug and secure connection. 
     In operation, the area around the drain exit site of a patient is prepped in a standard fashion (see, e.g.,  FIG. 1 ). The drain receptacle is then removed, leaving the surgical drain D partially inside of a patient&#39;s body P (i.e., internal drain portion D I ) and extending partially outside of the patient&#39;s body P (i.e., external drain portion D E ). If a surgeon (or other medical/surgical personnel) inadvertently sews the internal drain portion D I  inside of the patient P (i.e., via a suture S sewn within the patient&#39;s body cavity), he or she may safely and efficiently remove the internal drain portion D I  from the patient P using the removal device  10  according to the following method. 
     The surgeon (or other medical/surgical personnel) obtains a removal device  10  from a hospital or surgical center&#39;s supply room. A set of differently sized removal devices  10  may be packaged together (e.g., in a kit) so that the surgeon (or other medical/surgical personnel) can select the correct size, based on the size of the surgical drain D. 
     Once the correctly sized removal device  10  is provided, the first end  16  thereof with the cutting means/crown reamer  12  is placed over the open distal end E and external drain portion D E  of the drain D and the removal device  10  is advanced towards the patient P (i.e., distally from the surgeon (or other medical/surgical personnel)), as indicated by Arrow A in  FIGS. 3 and 4 . The cutting means/crown reamer  12  of the first end  16  is brought into contact with the patient P&#39;s skin and the crown reamer  12  is turned counterclockwise so that the first, blunt edges  22  of the teeth  20  are moved into the patient P&#39;s skin without cutting into the patient P&#39;s skin, until resistance is met (see  FIG. 5 ). The crown reamer  12 /first end  16  of the removal device  10  is then turned clockwise with a gentle tension applied, so that the second, sharp edges  24  of the teeth  20  are advanced to cut through the suture S securing the internal drain portion D I  within the patient P. This facilitates the easy and safe removal of the internal drain portion D I , and the entire surgical drain D (e.g., still coupled to the removal device  10 ) from the patient P. The surgical drain D, removal device  10  and cut suture S can then be disposed of as medical waste. 
     In an alternate embodiment, the teeth  20  of the surgical drain removal device  10  are configured such that the removal device  10  is turned clockwise first, so that the first, blunt edges  22  of the teeth  20  move into the patient&#39;s skin without cutting into the patient&#39;s skin, until resistance is met. The crown reamer  12 /first end  16  of this embodiment of the removal device  10  is then turned counterclockwise with a gentle tension applied, so that the second, sharp edges  24  of the teeth  20  are advanced to cut through the suture S. 
     A second embodiment of a surgical drain removal device  110  of the present invention is shown in  FIG. 7 . The removal device  110  includes a hollow cylindrical body  114  with opposed first and second ends,  116 ,  118 . The first end  116  includes cutting means  112  having a plurality of protruding teeth  120  (i.e., a saw). Each of the teeth  120  is formed to have a blunt, or first, edge  122  on a first side and a sharp, or second, edge  124  on a second side. The blunt edge  122  functions as a leading edge, and the sharp edge  124  is configured to cut through a suture (not shown), with an otherwise generally similar structure and operation as the removal device  10  described above and illustrated in  FIGS. 2-6 . 
     The removal device  110  further includes a chamber  115  proximate the first end  116  and having a slot  117  that facilitates the capture of the suture into the chamber  115 , followed by the end and external portion of the surgical drain. The cutting means  112  are internally housed within the chamber  115 . Once captured in the chamber  115 , the suture is cut by the second, sharp edge  124  of the cutting means  112 . 
     A third embodiment of a removal device  210  of the present invention is shown in  FIG. 8 . The removal device  210  includes a hollow cylindrical body  214  with opposed first and second ends,  216 ,  218 . The first end  216  includes cutting means  212  including a cut-out configured to have a blunt, or first, edge  222  on a first side and a sharp, or second, edge  224  on a second side. The blunt edge  222  functions as a leading edge, and the sharp edge  224  is configured to cut through a suture (not shown), with an otherwise generally similar structure and operation as the removal device  10  described above and illustrated in  FIGS. 2-6 . 
     The dimensions of the blunt edges  22 ,  122 ,  222  and sharp edges  24 ,  124 ,  224  may be suitably chosen in order to carry out the practice of the invention disclosed herewith. The exact configuration and geometry of the blunt and sharp edges providing the desired level of bluntness and sharpness can be determined by one skilled in the art without undue experimentation, and all such configurations are to be included within the scope of the present invention. 
     The removal devices of the present invention allow for the rapid bedside removal of a surgical drain which has been inadvertently sewn into a patient. Hospitals and surgical centers would benefit from keeping a supply of the removal devices in stock and using them with surgical drains, as doing so would prevent a return to the operating room for the surgical removal of the inadvertently sewn-in drains. These inadvertently sewn-in drains add unnecessary costs to the hospitals/surgical centers and expose the hospitals/surgical centers and the surgeon to enormous liability, given the surgical/medical complications that they may cause in the patient. 
     Modifications, additions, or omissions may be made to the systems, apparatuses, and methods described herein without departing from the scope of the disclosure. For example, the components of the systems and apparatuses may be integrated or separated. Moreover, the operations of the systems and apparatuses disclosed herein may be performed by more, fewer, or other components and the methods described may include more, fewer, or other steps. Additionally, steps may be performed in any suitable order. As used in this document, “each” refers to each member of a set or each member of a subset of a set. 
     Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. Although specific advantages have been enumerated above, various embodiments may include some, none, or all of the enumerated advantages. It is intended that the embodiments described above be considered as exemplary only, with a true scope and spirit of the invention being indicated by the appended claims. Moreover, none of the features disclosed in this specification should be construed as essential elements, and therefore, no disclosed features should be construed as being part of the claimed invention unless the features are specifically recited in the claims. In addition, it should be understood that any of the features disclosed on any particular embodiment may be incorporated in whole or in part on any of the other disclosed embodiments. 
     In any interpretation of the claims appended hereto, it is noted that no claims or claim elements are intended to invoke or be interpreted under 35 U.S.C. 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim. 
     In general, any combination of disclosed features, components and methods described herein is possible. Steps of a method can be performed in any order that is physically possible. 
     All cited references are incorporated by reference herein. 
     Although embodiments have been disclosed, it is not desired to be limited thereby. Rather, the scope should be determined only by the appended claims. 
     While various embodiment of the present disclosure have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present disclosure, as set forth in the following claims. 
     The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure. 
     Moreover, though the present disclosure has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.