Patent Publication Number: US-2007118153-A1

Title: Extraction device and medical suturing device set

Description:
The present invention pertains to an extraction device and medical suturing device set used when anchoring human organs and paries.  
      Generally, when a catheter is inserted transdermally into the stomach, gallbladder, or other organs, a problem may arise in that the organ separates from the paries such that the catheter cannot be inserted into the organ. Therefore, it is necessary to anchor the organ and paries prior to catheter insertion and prevent the organ from separating from the paries.  
      Recently, the mainstream of medical suturing device sets has become a device in which two needles are used to hand over the suture within an organ, and knot both ends of the suture drawn out of the organism, thus anchoring the organ and paries. Such a device comprises a suture, a suture insertion needle capable of inserting a suture into an organ, and an organ anchoring needle equipped with a tubular external needle and an internal needle having a tip equipped with a snare loop inserted into and capable of sliding within the external needle; by means of the snare loop that bends axially with respect to the internal needle and that protrudes from the tip aperture of the external needle pursuant to the sliding motion of the internal needle, one end of the suture protruding from the suture insertion needle is supported and drawn out from the organism (for example, refer to Japanese Patent Application No. JP 5-161655 (1993), in particular  FIG. 4 ).  
      In a conventional medical suturing device set, two needles are used to hand over the suture, so when the relative positions of the needle tips within the organ after puncturing are not correct, or when there is insufficient space within the organ and the snare loop is deformed against the organ wall, it becomes difficult for the suture to be supported by the snare loop, so its use is limited to experienced health care personnel.  
     SUMMARY OF THE INVENTION  
      The object of the present invention is to offer an extraction device and medical suturing device set that solves the aforementioned problems by readily handing over the suture, so that it can be handled even by inexperienced health care personnel.  
      The invented extraction device is an extraction device used to extract a suture positioned within an organism to the outside of the organism, characterized by the fact that this is furnished with an extraction needle in which an engagement member is formed capable of catching onto that part of the suture positioned circularly within the organism is looped, and drawing this outside of the organism.  
      In the present invention, the suture inserted into the organism is engaged by the engagement member of the extraction needle, so it can be drawn out of the organism at a place that is different from the insertion location. Because this makes it easy to hand over the suture, it can be handled even by inexperienced health care personnel.  
      In one invented extraction device, the extraction device is furnished with a mantle that forms a cavity that permits the extraction needle to pass entirely through so as to be exposed from the tip. In the present invention, it is possible to insert the extraction needle into the cavity of the mantle, thus making it possible to reduce the invasiveness to the body when drawing the extraction needle on which the suture is caught outside of the body.  
      In one invented extraction device, the extraction device is furnished with: an extraction puncture needle formed with an internal cavity from the basal tip side through the apical tip side; and a pulling out device in which is formed an engagement member that can be inserted through the internal cavity so as to be exposed from the apical tip side of the extraction puncture needle, such that the portion that is exposed from the apical tip side of the extraction puncture needle engages part of the suture that has been positioned in a circular shape within the organism and draws it out from the organism.  
      In the present invention, it is possible to engage the suture that has been inserted into the organism by the engagement member of the extraction device, and draw it out of the organism, though the cavity of the extraction puncture needle, at a location that is different from the insertion location. This makes it easy to hand over the suture, so it can be handled even by inexperienced health care personnel.  
      In one invented extraction device, the engagement member is structured by a series of multiple hook elements; the hook elements are formed with a base that can support part of the suture, a primary extension that is connected to part of the base and extends towards the basal tip of the pulling out device, a secondary extension that is connected to the other part of the base and that extends to the basal tip of the pulling out device, and a gap that is formed so as to envelope the periphery of the suture by the base and the primary extension and the secondary extension, and the series of hook elements is structured so that the primary extension of a hook element is connected to the secondary extension of another hook element that is adjacent to the hook element.  
      In the present invention, it is possible to have a structure in which the hook elements are facing several different directions outwards, towards 2 outer directions, or towards 4 outer directions; there is no limitation of the peripheral positioning of hook elements, which thus makes it easy to engage the suture that has been disposed in an annular form.  
      In one invented medical suturing device set, a medical suturing device set that is used to anchor the organ of an organism to the paries of the aforementioned organism is furnished with: an insertion puncture needle, in which is formed an insertion through-hole from the basal tip side through the apical tip side, and that is able to puncture the paries from the outside such that the aperture of the insertion through-hole on the apical tip side is positioned within the organ; a suture that, passing through the insertion through-hole, is supplied within the organ from the aperture, and that is able to form a circular section within the organ; and any one of the aforementioned extraction devices that is able to engage part of the circular section of the suture and draw it out of the organism.  
      In the present invention, provision is made for an extraction device, an insertion puncture needle, and a suture, which makes it easy to hand over the suture, so the desired organ and paries can be securely anchored with low invasiveness even by inexperienced health care personnel. It is also possible to draw out a single suture from multiple locations, thus, by taking this together and ligating it, it becomes possible to anchor the organ in a plane. Here, anchoring the organ in a plane means that, for example, the organ is anchored by suturing such that the suture forms a triangular or quadrilateral surface within the organ. When the organ is thus anchored, there is no separation within the plane of the organ from the paries. 
    
    
     BRIEF INTRODUCTION TO THE DRAWINGS  
      Embodiments of the present invention will now be described by way of example only with reference to the accompanying drawings in which:  
       FIG. 1  is a side view of the medical suturing device set pertaining to Embodiment  1  of the present invention.  
       FIG. 2  is an explanatory diagram of the suture and the insertion puncture needle of  FIG. 1 .  
       FIG. 3  is a side view of the essential elements of the extraction device of  FIG. 1 .  
       FIG. 4  is a diagram explaining the operation of Embodiment 1 of the present invention.  
       FIG. 5  is a diagram explaining the operation subsequent to  FIG. 4 .  
       FIG. 6  is a diagram explaining the operation subsequent to  FIG. 5 .  
       FIG. 7  is a diagram explaining the operation subsequent to  FIG. 6 .  
       FIG. 8  is a diagram explaining the operation subsequent to  FIG. 7 .  
       FIG. 9  is a diagram explaining the operation subsequent to  FIG. 8 .  
       FIG. 10  is a side view of the essential elements of the extraction device of the medical suturing device set pertaining to Embodiment 2 of the present invention.  
       FIG. 11  is a side view of the essential elements of the extraction device of the medical suturing device set pertaining to Embodiment 3 of the present invention.  
       FIG. 12  is a side view of the essential elements of the extraction device of the medical suturing device set pertaining to Embodiment 4 of the present invention.  
       FIG. 13  is a side view of the essential elements of the extraction device of the medical suturing device set pertaining to Embodiment 5 of the present invention.  
       FIG. 14  is a side view of the essential elements of the extraction device of the medical suturing device set pertaining to Embodiment 6 of the present invention.  
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
     Embodiment 1  
       FIG. 1  is a side view of the medical suturing device set pertaining to Embodiment 1 of the present invention.  FIG. 2  is a partially axially cut-away mode side view of the suture and insertion puncture needle of  FIG. 1 .  FIG. 3  is a side view of the essential elements of the extraction device of  FIG. 1 . As shown in the figures, the medical suturing device set is structured by a insertion puncture needle  10  furnished with a suture  20 , and several extraction devices  30  (3 in the illustrated example).  
      The insertion puncture needle  10  is structured using a puncture needle  11  and hub  12 , with insertion through-hole  13  boring through these internally in the axial direction, such that suture  20  can slide within insertion through-hole  13 . The puncture needle  11  is formed so that its apical tip has a sharp angle, and suture  20  protrudes from the apical tip so as to form a loop section  20   a . The suture  20  may be constituted by a nylon thread, for example.  
      The extraction device  30  is formed by a extraction puncture needle  300 , which has a hub  33  and a metal needle  31  having an apical tip formed into a sharp angle, and pulling out device  32 . A cavity  31   a  is formed axially within extraction puncture needle  300 . The extraction device  30  is structured such that pulling out device  32  can slide within cavity  31   a  and exit and enter through the apical tip of extraction puncture needle  300 . The pulling out device  32  comprises a manipulation section  32   b  and an engagement member  32   a  that is contiguous with one end of the manipulation section  32   b.    
      The engagement member  32   a  is an entity where multiple hook elements have been serially fixed in a sequential alignment (approximately linear): first hook element  320   a , second hook element  321   a , third hook element  322   a , and fourth hook element  323   a , with an end of first hook element  320   a  being connected to one end of manipulation section  32   b.    
      The respective hook elements constitute hook shapes shaped approximately like the letter “J,” and are furnished with a base that can support part of suture  20 , a primary extension that is connected to part of the base and extends towards the basal tip of pulling out device  32 , a secondary extension that is connected to the other part of the base and that extends to the basal tip of pulling out device  32 , and a gap that is formed so as to envelope the periphery of suture  20  by the base and the primary extension and the secondary extension. The linking of companion hook elements is formed by connections between the primary extension and secondary extension of adjacent hook elements.  
      In this case, the J-shaped flat surface of second hook element  321   a  is attached approximately perpendicular to the J-shaped flat surface of first hook element  320   a , the J-shaped flat surface of third hook element  322   a  is attached approximately perpendicular to the J-shaped flat surface of second hook element  321   a , and the J-shaped flat surface of fourth hook element  323   a  is attached approximately perpendicular to the J-shaped flat surface of third hook element  322   a . It is also possible for them to be connected to each other at any angle, not necessarily perpendicular. When the adjacent hook elements  320   a ,  321   a ,  322   a , and  323   a  are positioned so as to be approximately perpendicular, the branches (projectional elements) of hook elements  320   a ,  321   a ,  322   a , and  323   a  face towards the outside, extending in 4 directions.  
      The engagement member  32   a  may also be structured so that the J-shaped flat surface of first hook element  320   a , the J-shaped flat surface of second hook element  321   a , the J-shaped flat surface of third hook element  322   a , and the J-shaped flat surface of fourth hook element  323   a  are positioned to be approximately on the same plane.  
      The method for using the medical suturing device set having the aforementioned structure (i.e., its operation), is explained in  FIGS. 4-9 . As shown in  FIG. 4 , the hub  12  of insertion puncture needle  10  is grasped, and the gastric wall  41  is punctured from abdominal wall  40  by puncture needle  11 . After the puncture, suture  20  is caused to slide along insertion through-hole  13  of insertion puncture needle  10 , and suture  20  is caused to project from the apical tip of insertion through-hole  13 , thus forming loop section  20   a . Then there are multiple punctures of extraction device  30  within the loop section  20   a  formed by suture  20 . The pulling out device  32  is thrust from the tip of metal needle  31  of extraction device  30 , and suture  20  is drawn from the outside of hub  12  of insertion puncture needle  10 . When this is done, as shown in  FIG. 5 , loop section  20   a  is snugly attached to metal needle  31  of multiple extraction devices  30 .  
      Next, as shown in  FIG. 6 , extraction device  30  is slightly drawn up to engage the loop section  20   a  of suture  20  in engagement member  32   a  of pulling out device  32 . Then, in the engaged condition, pulling out device  32  is stowed in cavity  31   a  of metal needle  31 , and in this condition extraction device  30  is pulled upwards, and the upwardly pulled suture  20  is separated from extraction device  30 . Then insertion puncture needle  10  is removed. When loop section  20   a  is pulled out by pulling out device  32 , it may be removed from the organism without being temporarily stowed in the cavity of extraction puncture needle  300 ; pulling out device  32  may be removed from suture  20 , and then extraction puncture needle  300  and insertion puncture needle  10  may be removed.  
      Then, as shown in  FIG. 7 , a number of thread circles  20   b ,  20   c , and  20   d , equal to the number of puncturing extraction devices  30 , are formed outside the body. Then, as shown in  FIG. 8, 20   f , which is one of the suture ends positioned on the side of insertion puncture needle  10 , is sequentially inserted into thread circles  20   b ,  20   c , and  20   d , which are positioned on the side of extraction device  30 . Then, as shown in  FIG. 9 , suture tips  20   e  and  20   f  are drawn together, knotted in the desired tightness, and thus fixed.  
      The foregoing explanation described a case where insertion puncture needle  10  was inserted and loop section  20   a  was formed, and extraction device  30  was inserted within loop section  20   a , but it is also possible for extraction device  30  to first be inserted, then insert insertion puncture needle  10  and form loop section  20   a , draw up insertion puncture needle  10 , and position extraction device  30  within loop section  20   a . The case was explained where the stomach was the organ to be sutured, but also applies to cases where other organs, such as the gallbladder or kidney, for example, are sutured.  
      In Embodiment 1, the structure is such that insertion puncture needle  10  and extraction device  30  are separated, so it is possible to pull out suture  20  formed in a ring shape through insertion through-hole  13  of insertion puncture needle  10  by means of pulling out device  32  of extraction device  30  at a position that is different from the insertion position, which makes it possible to freely select the puncture site together with the patient, and which also makes it possible to anchor the organ in plane shape, positioned within the organism, with only a single suture. Also, pulling out device  32  exits and enters along cavity  31   a  of metal needle  31  of extraction device  30 , which makes it possible to reduce the invasiveness towards the body when suture  20  is drawn out of the organism. This makes it possible to securely anchor the desired organ to the paries with low invasiveness, even by inexperienced health care personnel.  
     Embodiment 2  
       FIG. 10  is a side view of the essential elements of the extraction device pertaining to Embodiment 2 of the present invention. In Embodiment 2, engagement member  52   a  of pulling out device  52  has a helical shape, so as to seize loop section  20   a  of suture  20  on helical engagement member  52   a . More specifically, the engagement member  52   a  of pulling out device  52  is structured by a continuous helical element, and this helical section thrusts out from insertion puncture needle  10  so as to engage part of the formed loop section  20   a .  
      According to Embodiment 2, the engagement member  52   a  of pulling out device  52  is formed as a helical shape, so without being limited to the circumferential position of pulling out device  52 , it is easily able to engage the suture that is disposed in annular shape. Other than pulling out device  52 , the structure, method of use, and results of Embodiment 2 are identical to those of Embodiment 1 so the explanation [of identical aspects] may be omitted.  
     Embodiment 3  
       FIG. 11  is a side view of the essential elements of the extraction device pertaining to Embodiment 3 of the present invention. In Embodiment 3, engagement member  62   a  of pulling out device  62  has a paperclip shape, so that loop section  20   a  of suture  20  is seized on the paperclip-shaped section.  
      Here, pulling out device  62  is structured by a paperclip-shaped engagement section; for example, it may be formed by 3 U-shaped sections. More specifically, as shown in  FIG. 11 , a linear element has been bent on the side of metal needle  31  to form primary U-shaped element  620   a ; the vicinity of primary U-shaped element  620   a  has been bent on the side of primary U-shaped element  620   a  to form tertiary U-shaped element  622   a ; the vicinity of primary U-shaped element  620   a  has been further bent on the side of metal needle  31  to form secondary U-shaped element  621   a ; and the primary and secondary U-shaped elements  620   a  and  621   a  positioned in identical orientations with partial overlap and tertiary U-shaped element  622   a  positioned in the opposite orientation together form pulling out device  62 .  
      In Embodiment 3, the tip of pulling out device  62  is able to seize loop section  20   a  of suture  20 . Otherwise, the structure, method of use, and results of Embodiment 3 are identical to those of Embodiments 1 and 2, with the exception that the circumferential orientation has been limited, so the explanation may be omitted.  
     Embodiment 4  
       FIG. 12  is a side view of the essential elements of the extraction device pertaining to Embodiment 4 of the present invention. In Embodiment 4, extraction device  70  is structured from mantle  71  and extraction needle  72 , and a helical groove  72   a  is furnished on the lateral surface of extraction needle  72 .  
      The extraction device  70  is structured by mantle  71 , hub  33 , and extraction needle  72 , and an internal cavity (not shown) is formed axially within mantle  71 . The mantle  71  is formed so that its front tip is approximately perpendicular to its axis, thus differing from metal needle  31  shown in Embodiments 1-3, which is formed into a sharp angle. The extraction needle  72  is structured so that it is able to slide within the cavity and enter and exit from the apical tip. The extraction needle  72  is structured by a rod member, the apical tip of which forms a sharp angle, which is furnished with helical groove  72   a  axially along the outer lateral surface of the rod member, such that the loop section  20   a  of suture  20  can be seized in helical groove  72   a.    
      The extraction device  70  having the structure described above is used as follows: when extraction device  70  is inserted, the tip of extraction needle  72  punctures the organism in a condition where the tip of extraction needle  72  is exposed from the tip of mantle  71 . At this time, helical groove  72   a  is stowed in the cavity of mantle  71 . Then, after puncturing to a predetermined depth, the extraction needle  72  is inserted even deeper, such that a portion on which helical groove  72   a  has been formed is sufficiently exposed. In this condition it engages loop section  20   a  of suture  20 . Then the apical tip of extraction needle  72  is stowed within the cavity of mantle  71 , and in this condition extraction device  70  is drawn up, and after the drawing up operation suture  20  is removed from extraction device  70 .  
      Embodiment 4 makes it possible to engage loop section  20   a  of suture  20  by helical groove  72   a  continuously furnished on extraction needle  72 . In other respects the structure, method of use, and results are identical to that of Embodiments 1 and 2, so their explanation is omitted.  
     Embodiment 5  
       FIG. 13  is a side view of the essential elements of the extraction device pertaining to Embodiment 5 of the present invention. In Embodiment 4, the extraction device was structured by an extraction needle and an outer mantle, but in Embodiment 5 extraction device  80  is structured from only a hub  33  and extraction needle  82 . The extraction needle  82  is structured by a rod member, the apical tip of which is formed into a sharp angle, and helical groove  82   a  is furnished axially on the outer lateral surface of the rod member, such that loop section  20   a  of suture  20  may be seized in helical groove  82   a.    
      The aforementioned extraction device  80  punctures the organism directly by extraction needle  82 , the loop section  20   a  of suture  20  is caught in helical groove  82   a  of extraction needle  82 , and then drawn out of the body.  
      Embodiment 5 makes it possible to seize loop section  20   a  of suture  20  along the axis of extraction needle  82  by the continuous helical groove  82   a , and then draw suture  20  out of the body. In other respects the structure, method of use, and results are identical to that of Embodiment 4, so their explanation is omitted.  
     Embodiment 6  
       FIG. 14  is a side view of the essential elements for Embodiment 6 of the present invention. Embodiment 6 is similar to Embodiment 5 in that extraction device  90  is structured by only a hub  33  and extraction needle  92 .  
      The extraction needle  92  is structured by a rod member, the apical tip of which is formed into a sharp angle, and concavity  92   a  having a fixed width axially, and which is radially reduced around the perimeter of said rod member, such that loop section  20   a  of suture  20  is seized in this concavity  92   a.    
      Embodiment 6 makes it possible to seize loop section  20   a  of suture  20  by a fixed width along the axis of concavity  92   a  furnished on extraction needle  92 , and then draw suture  20  out of the body. In other respects the structure, method of use, and results are identical to that of Embodiment 5, so their explanation is omitted.