Abstract:
A method of implanting a support in a patient includes providing an anchor introducer that is wearable on a finger, and wearing the anchor introducer on the finger and positioning the anchor introducer such that at least a distal tip of the finger is available for palpating tissue internal to the patient. The method also includes attaching an anchor to the anchor introducer, and inserting the finger that is wearing the anchor introducer into an incision and palpating a tissue landmark inside a pelvis of the patient with the distal tip of the finger. The method additionally includes driving the anchor into the tissue landmark inside the pelvis of the patient, detaching the anchor from the anchor introducer, associating the support with the anchor, and securing the support to the tissue landmark inside the pelvis of the patient.

Description:
BACKGROUND 
       [0001]    Intracorporeal suturing of tissue during surgery presents challenges to the surgeon in that the surgeon is called upon to manipulate one or more suturing instruments within the confines of an incision formed in the patient&#39;s body. In some cases, the surgeon will use his/her finger(s) to dissect tissue or separate tissue along tissue planes to form a space within the tissue that allows the surgeon to palpate and identify a desired target location for placement of a suture. Often, the space formed in the dissected tissue is opened until it is large enough to receive both the surgeon&#39;s finger(s) and the suturing instrument(s). The space provides access to the identified target location where it is desired to place the suture. However, the intracorporeal target location is often disposed at an angle that is difficult to reach and can have a depth that precludes visualization of the target location. Delivering surgical instruments to the target location is challenging when the target location cannot be visualized by the surgeon. 
       SUMMARY 
       [0002]    One aspect provides a method of fixing a suture to tissue of a patient. The method includes placing an introducer onto a finger; attaching an anchor to the introducer; delivering the introducer into the patient&#39;s body with the finger; and driving the anchor with the finger into the tissue of the patient. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0003]    The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.  FIG. 1  is a side view of a digital suture fixation system including an introducer and an anchor delivery device according to one embodiment. 
           [0004]      FIG. 2  is a front view of the introducer illustrated in  FIG. 1 . 
           [0005]      FIG. 3  is a bottom view of the introducer illustrated in  FIG. 2 . 
           [0006]      FIG. 4  is a side view of an anchor as illustrated in  FIG. 1 . 
           [0007]      FIG. 5  is a side view of one embodiment of a suture assembly suited for use with the digital suture fixation system illustrated in  FIG. 1 . 
           [0008]      FIG. 6A  is a perspective view of a finger wearing the introducer illustrated in  FIG. 1  and palpating tissue of a patient. 
           [0009]      FIG. 6B  is a perspective view illustrating the placement of support material between the finger and the tissue of the patient. 
           [0010]      FIG. 6C  is a perspective view of the finger illustrated in  FIG. 6A  inserting an anchor through the support material and into the tissue of the patient. 
           [0011]      FIG. 6D  is a side view of the anchor illustrated in  FIG. 6C  fixing support material to the tissue of the patient. 
           [0012]      FIG. 6E  is a perspective view of one embodiment of support material delivered along a suture line to an anchor that has been placed into tissue. 
           [0013]      FIG. 7  is a side view of a hand placed inside of a glove that includes a delivery device configured to deliver an anchor intracorporeally into a patient according to one embodiment. 
           [0014]      FIG. 8A  is a side view of the delivery device and  FIG. 8B  is a top view of the anchor as illustrated in  FIG. 7 . 
       
    
    
     DETAILED DESCRIPTION 
       [0015]    In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims. 
         [0016]    It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise. 
         [0017]    Tissue includes soft tissue, which includes dermal tissue, sub-dermal tissue, ligaments, tendons, or membranes. As employed in this specification, the term “tissue” does not include bone. 
         [0018]    A finger cot covers, at most, one finger. One such finger cot is a thimble that covers only a portion of the finger, for example a distal portion of the finger. Another example of a finger cot is a flexible sleeve that covers a distal portion of the finger. In contrast, a glove covers all five fingers and a portion of the hand up to at least the wrist. 
         [0019]    One embodiment provides a digital suture fixation system having an introducer that is attachable to a finger of a person and a delivery device attached to the introducer. The introducer is configured to allow the finger to palpate and identify a landmark within a patient and the delivery device is configured to insert an anchor or a suture attached to an anchor into the landmark. Thus, the surgeon&#39;s finger delivers the anchor/suture such that the space formed in the dissected tissue to locate the landmark need not be so large as to accommodate a separate suturing instrument. 
         [0020]    In this specification “configured to allow the finger to palpate and identify a landmark” means that the finger has a level of sensitivity that allows the person to discriminate tissue boundaries and/or tissue layers. For example, oftentimes the person is palpating a location inside a patient that is not within view and embodiments of the digital suture fixation system provide an introducer that attaches to the person&#39;s finger while allowing the finger to sense and identify the tissue the person is touching. That is to say, the introducer does not diminish the sensitivity of at least the pad of the palpating finger. In one embodiment, the introducer includes a polymer thin-walled section having a wall thickness of less than about  0 . 005  inches that is suited for providing digital dexterity. In one embodiment, the introducer includes a window that allows the finger to directly contact the tissues that are palpated. 
         [0021]    Embodiments provide a digital suture fixation system that is configured to be donned over a finger of a surgeon to allow the finger to palpate and identify a landmark within the patient, where the system includes a delivery device configured to insert an anchor at the identified landmark. Other embodiments provide a digital suture fixation system having a thimble-like device that is configured to be affixed to a finger of a surgeon and yet allow the finger to palpate and identify a landmark within the patient. 
         [0022]    Embodiments provide a digital suture fixation system that allows the surgeon to use the same finger(s) that were used to dissect tissue and identify the target location to also place the anchor/suture. Since the finger both palpates the tissue and places the anchor/suture, the space formed in the dissected tissue need not be opened to be large enough to receive other suturing instrument(s). Since the finger has already been employed to identify the target landmark, the subsequent location of the target landmark is relatively easy, even if the intracorporeal target location is disposed at an angle that is difficult to reach with instruments. 
         [0023]      FIG. 1  is a side view of a digital suture fixation system  50  attached to a finger F according to one embodiment. System  50  includes an introducer  52  that is attachable to the finger F, a delivery device  54  that is attached to introducer  52 , and an anchor  56  that is removably attachable to deliver device  54 . 
         [0024]    The intracorporeal suturing of tissue often includes the surgeon using one or more fingers to dissect tissue from tissue planes. In one embodiment, introducer  52  is provided with a window  58  that is formed on a distal end portion to allow a finger pad P of the finger F to be exposed (uncovered) to palpate tissue of the patient and identify a landmark for the placement of anchor  56 . Surgeons rely upon their well developed dexterity to palpate and identify landmarks of a patient, and this is particularly the case when the surgeon is unable to visually view the landmark site. One embodiment of system  50  provides a window  58  that is sized to expose the pad P of the finger to allow the pad P to directly contact the tissue of the patient. 
         [0025]    As an example of the use of system  50 , in one embodiment the surgeon forms an incision in the patient, for example to access to pelvic floor. Thereafter, the surgeon places introducer  52  over the finger F and enters the incision to dissect tissue to locate a desired landmark within the patient. Having located the landmark within the patient, the surgeon removes the finger F from the patient and attaches anchor  56  to the delivery device  54 . Subsequently, the surgeon will retrace the intracorporeal pathway into the patient with the finger F having the introducer  52  in the anchor  56  attached to the delivery device  54  for placement of anchor  56  into the landmark. As described below, one or more anchors  56  are employed to repair or support the pelvic floor with the appropriate use of support material or suture line as determined by the surgeon during the surgery. In one embodiment, anchor  56  is pre-attached to the delivery device  54 . 
         [0026]    It is to be understood that the finger F of the surgeon could be enclosed within a glove, and the introducer  52  is suited for donning over the glove that encloses the finger F. 
         [0027]      FIG. 2  is a front view of introducer  52 . In one embodiment, introducer  52  includes a distal end  60  formed by the intersection of a top surface  62  and a bottom surface  64 . In one embodiment, window  58  is formed at the distal end  60  between the top surface  62  and the bottom surface  64  of the introducer  52 . As illustrated in  FIG. 1  and  FIG. 2 , in one embodiment introducer  52  is provided as a finger cot that is configured to snuggly fit over the finger F of the surgeon (or the finger F of the surgeon that is enclosed within a glove). 
         [0028]    Delivery device  54  is attached to the bottom surface  64  of introducer  52 . In one embodiment, delivery device  54  is provided as a U-shaped dock having a shelf  66  that is spaced a distance away from the bottom surface  64 . The anchor  56  ( FIG. 1 ) is configured to slide into the delivery device  54  and be frictionally captured between the shelf  66  and the bottom surface  64  of the introducer  52 . 
         [0029]    The introducer  52  is suitably fabricated from polymers that are configured to elastically constrict over a finger of the surgeon. Some of the suitable polymers for fabricating the introducer  52  include polybutylene, polynitrile, polyurethane including polyurethane from the family of elastic polymers sold under the tradename KRATION, silicone, or block copolymers. In one embodiment, introducer  52  is formed from a malleable metal core, for example aluminum, that is over molded with silicone. 
         [0030]      FIG. 3  is a bottom view of introducer  52  illustrating the U-shaped shelf  66 . In one embodiment, shelf  66  extends from a proximal end  68  of introducer  52  up to the window  58 . In this manner, delivery device  54  is located proximal of window  58  and does not impede with the window  58  or interfere with the dexterity of the finger pad P ( FIG. 1 ). 
         [0031]    Delivery device  54  is suitably fabricated from plastic materials such as polypropylene, polyethylene, silicone, or blends of polyolefin plastics. Delivery device  54  is attached to introducer  52 , for example by adhesives, ultrasonic welds, or molding. In one embodiment, introducer  52  and delivery device  54  are formed (molded) as a single integral unit. 
         [0032]      FIG. 4  is a side view of anchor  56 . In one embodiment, anchor  56  is provided as a tissue penetrating anchor including a flange  70  and a tissue penetrating barb  72  extending from flange  70 . Flange  70  provides an attachment mechanism to removably secure anchor  56  to delivery device  54  ( FIG. 2 ). The tissue penetrating barb  72  includes a leading end  74  configured to penetrate tissue and a trailing end  76  configured to secure barb  72  in the tissue and resist removal of barb  72  from the tissue after placement of anchor  56 . 
         [0033]      FIG. 5  is a side view of another embodiment of an anchor  56 ′ including a suture line  78  attached to flange  70 . In one embodiment, suture line  78  is connected to anchor  56 ′ and provides a pulley line along which support material or other material may be directed along line  78  to the tissue into which anchor  56 ′ is fixed. In one embodiment, anchors  56 ,  56 ′ are molded from polypropylene. In one embodiment, anchors  56 ,  56 ′ are molded from a polymer having a melting point similar to a melting point of suture line  78 , which enables suture line  78  to be thermally “welded” to anchors  56 ,  56 ′. Suitable suture line materials include suture employed by surgeons in effecting pelvic floor repair, such as polypropylene suture, or the suture identified as Deklene, Deknatel brand suture, as available from Teleflex Medical, Mansfield, Mass., or suture available from Ethicon, a Johnson&amp;Johnson Company, located in Somerville, N.J. 
         [0034]      FIGS. 6A-6E  illustrate embodiments of system  50  employed in a one-handed method of fixing a suture to tissue of a patient, or more particularly, a method of driving an anchor into tissue of the patient with the same finger that was employed to palpate/identify the target landmark. 
         [0035]      FIG. 6A  is a perspective view of digital suture fixation system  50  placed on the finger F. The pad P of the finger F is exposed in the window  58  of introducer  52  and is available to palpate tissue T of the patient. In one approach, the surgeon will place the introducer  52  onto the finger F, load the anchor  56  into the delivery device  54 , and follow a pathway into the tissue that has been previously dissected by the finger F. In this manner, the surgeon is able to identify the desired landmark on the tissue T just prior to deploying the anchor  56 . 
         [0036]      FIG. 6B  is a side view of a hand of the surgeon holding support material S at the landmark site of the tissue T. Digital suture fixation system  50  is configured to provide the surgeon with dexterity that allows the surgeon to handle and place the support material S at the desired landmark on the tissue T prior to fixing the anchor  56  into the tissue. 
         [0037]    The support material S includes materials suited to support the pelvic floor in repair of pelvic organ prolapse. Examples of suitable materials for support material S include synthetic materials, open mesh materials (woven or nonwoven), or biological (harvested tissue) materials. In one embodiment, support material S is provided as a woven polypropylene mesh material available from, for example, HerniaMesh, Chivasso, Italy. 
         [0038]      FIG. 6C  is a side view of the finger F employed to insert the anchor  56  through the support material S and into the tissue T. In one embodiment, the delivery device  54  provides a level of rigidity that enables the forceful deployment of anchor  56  through the support material S and into the tissue T. In some instances, the tissue T includes ligaments or other tough, durable connective tissue and the system  50  is compatible with the placement of anchors  56  into these and other tissues. 
         [0039]      FIG. 6D  is a side view of anchor  56  fixed into the tissue T to hold support material S in place at the desired landmark as identified by the surgeon. 
         [0040]      FIG. 6E  is a side view of another embodiment of a suture assembly including suture line  78  attached to anchor  56 ′. In one embodiment, the support material S is loaded onto or otherwise coupled to a proximal end of the suture line  78  for subsequent delivery along the suture line  78  down to the placed anchor  56 ′. For example, in one embodiment the anchor  56 ′ is placed in a sacrospinous ligament of the patient and a proximal end of the suture line  78  trails to a location outside of the patient. The surgeon attaches the support material S to the suture line  78  outside of the patient&#39;s body and is able to deliver the support material S intracorporeally to the identified landmark where the anchor  56 ′ has been placed. For example, in one approach the surgeon employs a pulley-like motion to move the support material S along the suture line  78  from a location outside of the patient intracorporeally to the anchor fixed in the desired landmark. Thereafter, the surgeon will tie off or otherwise secure the support material S to the tissue T. This approach allows the surgeon to accurately place the support material S intracorporeally at the landmark within the patient without actually visualizing the landmark. 
         [0041]    Embodiments of the suturing system and devices described herein provide a method of digitally suturing tissue that is useful in many surgical procedures, including the treatment of pelvic organ prolapse. For example, embodiments provide a suturing system  50  suited for the surgical treatment of pelvic organ prolapse that is operable by a surgeon to suture a scaffold or other support to a ligament or other tissue to reinforce the pelvic floor. With some surgical procedures it is desirable to apply sutures to the sacrospinous ligament and/or in the arcus tendineus ligament to attach a synthetic scaffold thereto that is configured to support the pelvic floor and reduce or eliminate the undesirable effects of pelvic organ prolapse. The digital suture fixation systems described herein are compatible with these approaches to support the pelvic floor. 
         [0042]    One embodiment provides a method of fixing a suture to tissue of a patient that includes placing an introducer onto a finger, attaching a suture assembly to the introducer, where the suture assembly has a suture line and an anchor attached to the suture line, delivering the introducer into the patient&#39;s body with the finger, and attaching the anchor to the tissue of the patient with the finger. 
         [0043]    In a typical procedure related to the repair of pelvic organ prolapse, a catheter is placed in the patient&#39;s urethra U, along with other recommended, desirable, and preliminary steps in preparation for surgery. The patient is typically placed on an operating table in a lithotomy position (or modified lithotomy position) with buttocks extending just beyond an edge of the table. With the patient under anesthesia, a vaginal incision or a perineal incision or another suitable incision is made by the surgeon. Thereafter, the surgeon typically dissects tissue using his/her fingers (or a suitable instrument) and then palpates the patient with his/her fingers to identify a desired landmark, such as the sacrospinous ligament or arcus tendineus ligament or other tissue landmark. 
         [0044]    The surgeon has thus gained intracorporeal access to the landmark with his/her fingers. The systems described herein allow the surgeon to place an introducer onto a finger and attach a suture assembly to the introducer for direct digital placement of the suture assembly to the landmark. To this end, the surgeon delivers the introducer and anchor into the patient&#39;s body with the finger, for example by following the intracorporeal path already dissected through the tissue. The systems thus allow the surgeon, with little additional effort, to attach the anchor to the tissue of the patient digitally with the finger/introducer. In one embodiment, the introducer is placed proximal a distal tip of the finger such that the distal tip of the finger is free to contact the intracorporeal tissue/landmark within the patient. The placement of anchors and/or suture line is repeated in this manner until the surgeon is satisfied with the repair of the pelvic floor. 
         [0045]    In one embodiment, a suture line is attached to the deployed anchor and is available for delivering support material intracorporeally to the anchor previously placed in the patient. For example, the proximal end of the suture line is removed from the patient&#39;s body to a location where the surgeon may attach support tissue to the suture line. The support material may be accurately placed intracorporeally into the patient (e.g., by a “pulley” method of moving the support material along the suture line) since the distal end of the suture line is attached to the anchor that has already been placed/fixed in the desired landmark. 
         [0046]      FIG. 7  is a side view of another embodiment of the digital suture fixation system  100 . In one embodiment, system  100  includes an introducer  102  that is attachable to a hand H and a finger F of the person, a delivery device  104  attached to the introducer  102 , and a suture assembly  106  that is removably attachable to the delivery device  104 . In one embodiment, the introducer  102  is provided as a glove that fits over the hand H and the suture assembly  106  includes a suture line  108  connected to an anchor  110 . 
         [0047]    In one embodiment, the introducer  102  includes a flexible glove such as a nitrile glove or a latex-free glove and the delivery device  104  is provided as a rigid base attached to one of the fingers of the glove. In one embodiment, the glove  102  is fabricated from a polymer having a thin-walled section provided at least at the pad of the finger. As an example, the glove  102  is fabricated from a film having a wall thickness in the region of the pad of less than about 0.005 inches that is suited for providing digital dexterity to the finger. 
         [0048]    In one embodiment, anchor  110  is a tissue penetrating anchor provided as a tube including a barb portion  111  opposite a base  120 . 
         [0049]      FIG. 8A  is a side view of delivery device  104  and  FIG. 8B  is a top view of suture assembly  106 . In one embodiment, delivery device  104  includes a post  112  extending from one of the fingers of the glove  102  and a flange  114  extending from the post  112 . In one embodiment, the anchor  110  includes a bore  122  formed in the base  120 , where the bore  122  includes a slot  124 . In one embodiment, the slot  124  is formed as a helical slot having an entry portion that opens to the base  120  and an end portion located at axial distance away from the base  120  inside of the anchor  110 . 
         [0050]    The post  112  of the delivery device  104  is sized to fit inside of the bore  122 , and flange  114  is sized to mate with the slot  124 . Turning the anchor  110  by approximately 90 degrees (i.e., a quarter turn clockwise) secures the anchor  110  to the post  112  by seating the flange  114  in the slot  124 . In this manner, anchor  110  is removably secured to the delivery device  104 . After placement of the anchor  110  by the hand H inside of the introducer  102 , a delivery device  104  is detachable from anchor  110  by turning the delivery device  104  approximately  90  degrees counterclockwise relative to the anchor  110 . 
         [0051]    In one embodiment, the delivery device  104  is a holder having a first mating surface configured to mate with a second mating surface formed on the base  120  of the anchor  110  such that the holder  104  is configured to decouple from the anchor  110  by separating the first mating surface from the second mating surface. Suitable mating surfaces between the holder  104  and the base  120  include adhesive surfaces, where at least one of the surfaces of the holder  104  and the base  120  is provided with an adhesive; mechanical surfaces such as tongue and groove surfaces as one example; or hook and loop surfaces where one of the surfaces of the holder  104  and the base  120  is provided with a loop structure that mates with a hook structure provided on the other of the holder  104  and the base  120 . In one embodiment, the first mating surface of the holder  104  is a convex surface and the second mating surface formed on the base  120  of the anchor  110  is a concave surface, or vice versa. 
         [0052]    The suture line  108  is similar to the suture line  78  ( FIG. 5 ). In one embodiment, suture assembly  106  is employed in a manner that is similar to suture assembly  56 ′ ( FIG. 5 ) and provides a trailing suture line  108  that is configured to be directed from the anchor site out of the patient for access by the surgeon, which allows the surgeon to deliver support material S back along the suture line  108  to the landmark inside the patient. Thus, embodiments provide for the placement of support material into a small incision at a desired intracorporeal landmark where the surgeon does not have actual visualization of the landmark. 
         [0053]    Embodiments of digital suture fixation systems have been described that include a digital introducer that is attachable to a finger that is used to guide an anchor delivery device intracorporeally to a patient. The introducer is configured to allow the finger to palpate and identify a landmark within a patient and the delivery device is configured to insert an anchor or a suture attached to an anchor into the landmark. Thus, the surgeon&#39;s finger is used to deliver the anchor/suture and the space formed in the dissected tissue to locate the landmark may consequently be reduced. 
         [0054]    Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.