Abstract:
Methods and apparatus for actuating first and second fasteners to secure a medical clamp to a patient. An exemplary fastening device comprises a first rotatable member configured to rotate from an outward position to an inward position to engage the first fastener and a second rotatable member configured to rotate from an outward position to an inward position to engage the second fastener. The first and second rotatable members are mechanically coupled to enable concurrent engagement of the first and second fasteners.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims a priority benefit, under 35 U.S.C. §119(e), to U.S. provisional patent application Ser. No. 61/518,680, entitled “Medical Clamp Fastener System and Surgical Stapler for Same,” filed on May 10, 2011. This application is incorporated herein by reference. 
     
    
     FIELD 
       [0002]    This application relates to an improved medical clamp fastener system and a surgical stapler for same. 
       BACKGROUND 
       [0003]    A central venous catheter is a catheter typically placed into a large vein in the neck, chest or groin. The catheter may be used to administer medication or fluids, obtain blood tests, obtain cardiovascular measurements, and the like. 
         [0004]    A catheter clamp system may be used to secure the catheter in place on the patient. One conventional catheter clamp system includes a sleeve about the catheter. A clamp with apertures for receiving sutures is then attached to the sleeve. The clamp is then stitched through the apertures and into the skin of a patient to secure the clamp in place on the patient. 
         [0005]    However, stitching a conventional catheter clamp system to the skin of a patient takes time and is more prone to accidental needle stick injuries to the medical professional and/or transmission of infection from the patient to the medical professional as a result of such needle stick injuries. 
         [0006]    One conventional medical device anchoring system for securing a catheter to a patient is disclosed in U.S. Pat. No. 7,799,000. As disclosed therein, a fixation apparatus includes opposing wings that include a staple receiving portion allegedly configured to receive surgical staples. The stapling receiving portions each have distal and proximate ends that include staple retaining ends that are configured to inhibit the staple receiving portions from dislodging from staples. The fixation apparatus also includes apertures  27  used for conventional sutures. 
       SUMMARY 
       [0007]    One embodiment described herein is directed to a fastening device for actuating first and second fasteners to secure a medical clamp to a patient. The fastening device comprises a first rotatable member configured to rotate from an outward position to an inward position to engage the first fastener and a second rotatable member configured to rotate from an outward position to an inward position to engage the second fastener. The first and second rotatable members are mechanically coupled to enable concurrent engagement of the first and second fasteners. 
         [0008]    Another embodiment described herein is directed to an apparatus for securing a medical device to a patient. The apparatus comprises a medical clamp and a fastening device for the actuating first and second fasteners to secure the medical clamp to a patient. The fastening device comprises a first rotatable member configured to rotate from an outward position to an inward position to engage the first fastener and a second rotatable member configured to rotate from an outward position to an inward position to engage the second fastener. The first and second rotatable members are mechanically coupled to enable concurrent engagement of the first and second fasteners. 
         [0009]    A further embodiment described herein is directed to a method of actuating first and second fasteners to secure a medical clamp to a patient. The method comprises rotating a first rotatable member of a fastening device from an outward position to an inward position to engage the first fastener and, concurrent with rotating the first rotatable member, rotating a second rotatable member of the fastening device from an outward position to an inward position to engage the second fastener. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    Other objects, features and advantages will occur to those skilled in the art from the following description of a preferred embodiment and the accompanying drawings, in which: 
           [0011]      FIG. 1  is a three-dimensional view of a central venous catheter with a conventional catheter clamp system attached thereto; 
           [0012]      FIG. 2  is a three-dimensional view showing a silicone sleeve of the conventional catheter clamp system shown in  FIG. 1 ; 
           [0013]      FIG. 3  is a three-dimensional view showing a clamp of the conventional catheter clamp system shown in  FIG. 1 ; 
           [0014]      FIG. 4  is a three-dimensional view showing an enlarged view of the conventional catheter clamp system of  FIG. 1 ; 
           [0015]      FIG. 5  is a three-dimensional view of one embodiment of the medical clamp fastener system of this invention; 
           [0016]      FIG. 6  is a three-dimensional bottom view of the medical clamp shown in  FIG. 5 ; 
           [0017]      FIG. 7  is a three-dimensional view showing one example of the medical clamp shown in  FIGS. 5 and 6  secured to a sleeve coupled to a catheter; 
           [0018]      FIG. 8  is a three-dimensional view of a conventional surgical stapler which may be used to secure the medical clamp shown in  FIGS. 5-7  to the skin of a patient; 
           [0019]      FIG. 9  is a three-dimensional view of another embodiment of the medical clamp fastener system of this invention used to secure a G-tube or J-tube in place on a patient; 
           [0020]      FIG. 10  is a three-dimensional view showing an example of a G-tube or J-tube in place in the abdomen of a patient; 
           [0021]      FIG. 11  is a schematic front view of one embodiment of the surgical stapler of this invention used to secure a medical clamp to a patient, such as the medical clamp shown in  FIGS. 5-7  and  9 ; 
           [0022]      FIG. 12A  is a perspective view showing in further detail the structure of the anvil members and the plunger shown in  FIG. 11 ; 
           [0023]      FIG. 12B  is a cross-sectional view of the portion of the surgical stapler shown in  FIG. 12A ; 
           [0024]      FIG. 13  is a schematic side view of the surgical stapler shown in  FIG. 11 ; 
           [0025]      FIG. 14  is an enlarged view showing one example of a surgical staple in place below the plunger shown in  FIG. 13 ; 
           [0026]      FIG. 15  is a three-dimensional view showing in further detail one example of the shape of the anvils shown in  FIG. 12B ; 
           [0027]      FIGS. 16 and 17  are three-dimensional views showing one example of the operation of the surgical stapler shown in  FIGS. 11-15 ; 
           [0028]      FIG. 18A  is a side view of a conventional staple in an undeployed state; 
           [0029]      FIG. 18B  is a side view of the staple of  FIG. 14  in an undeployed state; 
           [0030]      FIG. 18C  is a side view of the staple of  FIG. 18A  in a deployed state; and 
           [0031]      FIG. 18D  is a side view of the staple of  FIG. 18B  in a deployed state. 
       
    
    
     DETAILED DESCRIPTION 
       [0032]    Aside from the preferred embodiment or embodiments disclosed below, this invention is capable of other embodiments and of being practiced or being carried out in various ways. Thus, it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the drawings. If only one embodiment is described herein, the claims hereof are not to be limited to that embodiment. Moreover, the claims hereof are not to be read restrictively unless there is clear and convincing evidence manifesting a certain exclusion, restriction, or disclaimer. 
         [0033]      FIG. 1  shows an example of a typical central venous catheter  10  having a large bore which is coupled to a three-port catheter system  12 . Conventional catheter clamp system  14  is used to secure catheter  10  in place on the skin of a patient. Conventional catheter clamp system  14 ,  FIG. 4 , includes sleeve  15 ,  FIG. 2 , which is inserted over catheter  10  and clamp  18 ,  FIG. 3 , which is secured (snapped) to sleeve  15 .  FIG. 4  shows an example of a conventional catheter clamp system  14 , comprising sleeve  15 ,  FIG. 2  , in place over catheter  10  and clamp  18 ,  FIG. 3 , secured to sleeve  15 . 
         [0034]    Conventional catheter clamp system  14 ,  FIGS. 1 and 4 , is then stitched to the skin of a patient to hold it in place. However, stitching catheter clamp system  14  to the skin of a patient takes time and is more prone to accidental needle stick injuries to the medical professional and/or transmission of infection from the patient to the medical professional as a result of such needle stick injuries. 
         [0035]    In contrast, medical clamp fastener system  20 ,  FIG. 5 , of one or more embodiments of this invention includes a sleeve  16  which is placed over catheter  10 ,  FIG. 7 , similar as discussed above with reference to  FIGS. 1-4 . System  20 ,  FIG. 5 , also includes medical clamp  22  configured to be secured to sleeve  16 . Clamp  22  preferably includes circular shaped notches  23 ,  FIG. 6 , which engage circular shaped grooves  25 ,  FIG. 5 , in sleeve  16  to secure clamp  22  to sleeve  16 .  FIG. 7  shows one example of sleeve  16  about catheter  10  and clamp  22  secured to sleeve  16 . 
         [0036]    Medical clamp  22 ,  FIG. 5 , includes flanges  24  and  26  which each include notches, e.g., notches  28 ,  30  on flange  24 , and notches  29 ,  31  (shown in further detail in  FIG. 6 ) on flange  26 , each of which are configured to receive a surgical staple therein. The notches on the flanges allow the surgical staples to extend into the skin of the patient to secure clamp  22  to the skin of a patient. In one example, conventional surgical stapler  35 ,  FIG. 8 , may be used to staple medical clamp  22 ,  FIG. 7 , to the skin of patient to secure medical clamp system  20  coupled to catheter  10 . 
         [0037]    Medical clamp system  20  or variations thereof may be used to secure catheters or other devices, such as gastric feeding tubes (or “G-tubes”), jejunostomy tubes (“J-tubes”), or wires, to a patient&#39;s skin. The portion of such devices affixed to the patient&#39;s skin may have a generally tube-shaped configuration. 
         [0038]    One exemplary device that may be used with medical clamp system  20  is a temporary transvenous pacemaker. In particular, the wire of a temporary transvenous pacemaker may be affixed to the skin of a patient using medical clamp system  20  or a variation thereof. The wire of the temporary transvenous pacemaker may have a diameter that is approximately one-fifth the diameter of a central venous catheter. To compensate for such differences, sleeves having different inner diameters may be used with medical clamp system  20 . 
         [0039]    G-tubes and J-tubes may have diameters about ten times greater than catheter tube  10 ,  FIG. 7 .  FIG. 10  shows an example of G-tube  40  inserted through abdomen  42  of a patient. Clamp  22 ′,  FIG. 9 , in this example, preferably includes a plurality of flanges  30 ,  32 ,  34 ,  36 , which each similarly include notches, e.g., notches  38  and  40  on flange  30 , designed to receive a surgical staple and secure medical clamp  22 ′ to the skin of a patient to ensure the G-tube or J-tube stays in place on a patient. 
         [0040]    The medical clamp system  20  described herein may save time by using surgical staples that can be quickly and easily used to secure medical clamp  22  to the skin of a patient. Because system  20  uses surgical staples, system  20  provides a more secure attachment to the skin of a patient than conventional catheter clamp systems. Using staples is also less prone to accidental needle stick injuries to the medical professional and/or transmission of infection from the patient to the medical professional as a result of such needle stick injuries. 
         [0041]    Although as discussed above, a conventional surgical stapler may be used to secure medical clamp system  20  to a patient, there may be problems associated with using a conventional surgical stapler. For example, using a conventional surgical stapler may be cumbersome and difficult to use with medical clamp  22  because it may require the use of both right and left hands. Moreover, aligning the anvil with the notches of one or more embodiments of the medical clamp may be difficult. Another problem associated with using a conventional surgical stapler may be that the thickness of flanges  24 ,  26 ,  FIGS. 5-7  of medical clamp  22  and/or flanges  30 - 36  of clamp  22 ′,  FIG. 9 , may be too thick for the surgical staples used with a conventional surgical stapler. As a result, the staples may not extend at a sufficient depth to effectively secure medical clamp  22  to the skin of a patient. 
         [0042]    To overcome these problems, surgical stapler  50 ,  FIG. 11  of one embodiment of this invention is designed to be used with medical clamp  22 ,  FIGS. 5-7  and  9 , or similar type medical clamps. Surgical stapler  50 ,  FIG. 11 , includes handle  52  pivotably attached to base  54 . Linking member  56  is attached to handle  52  on one end and to moveable plunger  58  on the other end. Plunger  58  is preferably symmetrical on both sides, as shown in further detail in  FIG. 12B , and includes ends  59  which each engage a staple, e.g., staples  61 ,  63 . Ends  59  preferably have a rounded shape, e.g., as shown at  79 ,  FIG. 13 , which is designed to engage the top of staples  61 ,  63 ,  FIG. 12B , as they are stapled to the skin of a patient.  FIG. 14  shows an enlarged top view of one side of plunger  58  with end  59  which, in this example, engages staple  61 . 
         [0043]    Surgical stapler  50 ,  FIG. 11 , includes two opposing anvil members  60  and  62  pivotably coupled to base  54 , e.g., with screws  67 ,  69 . In one design, springs, e.g., spring  81 ,  FIG. 12A , may be used to maintain anvil members  60 ,  62 , in the open position as shown in  FIG. 11 . Anvil members  60 ,  62 ,  FIGS. 12A and 12B , each include anvils  64 ,  66 , respectively. Anvils  64 ,  66  are shaped to bend staples  61 ,  63 , respectively, above flanges  24 ,  26 ,  FIGS. 5-7 , of clamp  22  and into the skin of a patient.  FIG. 15  shows an enlarged view of anvil members  60  and  62  and anvils  64  and  66 . 
         [0044]    Anvil members  60  and  62 ,  FIG. 11 , are spread out, or in the open position, as discussed above, when handle  52  is not depressed. Plunger  58 ,  FIG. 12B , preferably includes opposing sloped shoulders  80 ,  82  which engage anvil members  60 ,  62 , respectively, when plunger  58  is moved downward. For example, when handle  52 ,  FIG. 16 , is pressed downward, as shown by arrow  68 , plunger  58  moves in the downward direction, as shown by arrow  70 . This causes shoulders  80 ,  82 ,  FIG. 12B , to pass through the notches in anvil members  60 ,  62  and move them to the closed position as shown in  FIG. 17 . For example, shoulder  80 ,  FIG. 16 , passes through notch  84  and area  86  of plunger  58  causes anvil member  60  to move to the closed position, as shown in  FIG. 17 . At this point, plunger  58  has pushed staples  61  and  63 ,  FIG. 12B  into the notches of medical clamp  22 ,  FIG. 5-7 , while anvils  64  and  66 ,  FIG. 12B , bend staples  61  and  63  above the flanges of medical clamp  22  to secure medical clamp  22  to the skin of a patient. 
         [0045]    Although as discussed above with reference to  FIGS. 11-17 , surgical stapler is shown to staple two staples in the notches on the opposing flanges of medical clamp  22  as shown in  FIGS. 5-7 , this is not a necessary limitation of this invention. In other examples, stapler  50  may be designed to deliver one staple for use with a medical clamp, such as medical clamp  22 ′,  FIG. 9 , e.g., for gastric G-tubes, J-tubes, and the like. 
         [0046]    Stapler  50  may align the surgical staples with the notches of medical clamp  22  and insert them at a sufficient depth so that medical clamp  22  is properly secured to the skin of a patient. Stapler  50  is easy to use with medical clamp  22  and can be used with one hand. 
         [0047]      FIGS. 18A-D  show a conventional staple  88  contrasted with an exemplary staple  61  that may be used with the stapler  50  and medical clamps  22  and  22 ′ described herein. As shown in  FIG. 18A , the conventional staple  88  has a width of 9 mm and a height of 5 mm prior to deployment. The top of staple  88  includes two rounded bumps having a height of 2.5 mm, as measured from the base of the bumps to the top of the bumps. In contrast, staple  61 , shown in  FIG. 18B , has a greater height, which allows deeper penetration of the staple into the skin. In particular, staple  61  has a width of approximately 9 mm and a height of approximately 7 mm prior to deployment. The top of staple  61  includes two rounded bumps having a height of approximately 4 mm, as measured from the base of the bumps to the top of the bumps.  FIG. 18C  shows the conventional staple  88  after deployment. The staple  88  is deployed by applying a downward force to the bumps, thereby flattening them. The ends of the deployed staple  88  are pushed together, but do not overlap. The deployed staple  88  has a width of 6.5 mm and a height of 5 mm.  FIG. 18D  shows the staple  61  after deployment. Similar to staple  88 , staple  61  is deployed by applying a downward force to the bumps, thereby flattening them. The ends of the deployed staple  61  are pushed together and overlap in parallel fashion by approximately 1.5 mm. The deployed staple  61  has a width of approximately 6.5 mm and a height of approximately 7 mm. Staple  61  may be formed of surgical stainless steel or another suitable material. 
         [0048]    Staple  61 , which may be the same as staple  63  described herein, differs from staple  88  in at least two ways. First, the height of the staple  61  is greater, which allows for deeper penetration of the staple into the skin. The height of staple  61  may be such that the staple penetrates tissue by an optimal holding depth without risking damages to the structures underlying the skin, such as blood vessels and nerves. Second, in the deployed state, the staple  61  includes overlapped ends, which form a “virtual” closed circle. Thus, the deployed staple  61  may be more stable in the skin than staple  88 , which does not have overlapping ends in the deployed state. 
         [0049]    While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure. 
         [0050]    Also, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments. 
         [0051]    All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms. 
         [0052]    The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” 
         [0053]    The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and/or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and/or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc. 
         [0054]    As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and/or” as defined above. For example, when separating items in a list, “or” or “and/or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of” or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law. 
         [0055]    As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and/or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc. 
         [0056]    In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of” and “consisting essentially of” shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.