EP0844847A1 - Chirurgisches klammergerät und verfahren zum chirurgischen befestigen - Google Patents

Chirurgisches klammergerät und verfahren zum chirurgischen befestigen

Info

Publication number
EP0844847A1
EP0844847A1 EP97907256A EP97907256A EP0844847A1 EP 0844847 A1 EP0844847 A1 EP 0844847A1 EP 97907256 A EP97907256 A EP 97907256A EP 97907256 A EP97907256 A EP 97907256A EP 0844847 A1 EP0844847 A1 EP 0844847A1
Authority
EP
European Patent Office
Prior art keywords
tissue
suture
organ
row
suture elements
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP97907256A
Other languages
English (en)
French (fr)
Other versions
EP0844847A4 (de
Inventor
Sergey Popov
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sa Development Of Advanced Medical Products Ltd
Original Assignee
Sa Development Of Advanced Medical Products Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sa Development Of Advanced Medical Products Ltd filed Critical Sa Development Of Advanced Medical Products Ltd
Publication of EP0844847A1 publication Critical patent/EP0844847A1/de
Publication of EP0844847A4 publication Critical patent/EP0844847A4/de
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07235—Stapler heads containing different staples, e.g. staples of different shapes, sizes or materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2901—Details of shaft
    • A61B2017/2905—Details of shaft flexible

Definitions

  • the present invention relates to apparatus for surgically connecting two portions of a hollow organs of the digestive system.
  • Surgical staplers providing either one row, or two concentric rows, of sutures are known for achieving anastomosis - or connection - between two generally tubular portions of hollow organs of the digestive system.
  • USSR Patent No. 264612 describes circular anastomosis by use of a single row staple suture
  • US Patent No. 4198982 describes double row staple suturing.
  • surgical staplers of the sort which provide anastomosis of hollow organs are formed of a suturing head which is attached to an elongate body, and an anvil.
  • the elongate body is inserted via an opening in one side of the hollow organ, and the anvil is placed in the other.
  • the ends of the organ portions to be connected are placed together and positioned between the suturing head and the anvil.
  • Anastomosis is provided by operating the suturing head such that the staples therein are ejected through the organ tissue and against the anvil, thereby to be plastically deformed and to provide a desired connection of the organ portions.
  • the entire stapler, including the anvil, which is removably connected to the suturing head is subsequently withdrawn from the hollow organ.
  • Single row staple suturing is characterized by low traumatization to the sutured tissue, anastomosis that is sufficiently elastic so as to facilitate relatively easy extraction of the stapler from the organ, and by not significantly obstructing blood supply to the sutured tissue. It is also characterized, however, by applying insufficient pressure to organ tissue connected to the mesentery. Accordingly, due to the greater density of blood vessels in the organ tissue connected to the mesentery, the tissue to be connected is not fixated properly, and it is thus difficult to achieve anastomosis.
  • the present invention seeks to provide a novel method of surgical suturing of hollow organs to as to provide anastomosis thereof, and a novel surgical stapler for performing this method, which overcomes disadvantages of known art.
  • the present invention seeks to provide reliable haemostasis and fixation of connected ends of sutured hollow organs, while also providing good conditions for tissue regeneration, minimal traumatization of sutured tissue, and a reduced probability of post-operative suture stenosis.
  • a further object of the invention is to optimize haemostasis of sutures while maintaining a sufficient blood supply to the sutured tissue.
  • a suturing device for providing anastomosis of first and second hollow organ portions each having an open end for suturing together with each other across a common interface
  • the device includes: an elongate tubular housing having a first free end, and a second end, the housing being configured for insertion through the first hollow organ portion such that the second end is associable with the open end thereof; and suturing apparatus, associated with the second end of the tubular housing, for suturing together the open ends of the first and second organ portions by insertion of suture elements therethrough along the entire Iength of the common interface and thereacross, and wherein the suturing apparatus includes: apparatus for inserting a single row of suture elements through the organ tissue along a portion of the common interface, and apparatus for inserting a double row of suture elements through the organ tissue along the remainder of the common interface.
  • the apparatus for inserting a single row of the suture elements includes apparatus for inserting through the organ tissue a first row of suture elements having a first predetermined spacing
  • the apparatus for inserting a double row of the suture elements includes apparatus for inserting a double row of the suture elements having other predetermined spacings, different from the first predetermined spacing, wherein the spacings are predetermined to apply to the suture tissue a varying force along the entire suture predetermined so as to facilitate adequate blood supply to the suture tissue while not preventing haemostasis, thereby to facilitate optimal healing of the tissue.
  • the apparatus for inserting a double row of suture elements includes apparatus for inserting a second row of suture elements, having a second predetermined spacing, and apparatus for inserting a third row of suture elements generally parallel to the second row, and having a third predetermined spacing, different from the first and second predetermined spacings.
  • the first, second and third rows of suture elements include deformable suture elements.
  • each suture element is a deformable suture element which has a pair of legs extending generally parallel to the longitudinal axis of the housing, and arranged for transverse insertion through the organ tissue.
  • Each suture element also has a transverse portion connecting the pair of legs, and the suturing device further includes an anvil constructed for placement in the open end of the second hollow organ portion, and having formed on a rear face thereof a single row of recesses extending along a portion of the anvil periphery, and a double row of recesses extending along the remainder of the anvil periphery, for receiving and cooperating with the single and double rows of suture elements , respectively, after insertion thereof through the organ tissue; and apparatus for selectably connecting the anvil to the housing.
  • the apparatus for inserting a single row of the suture elements includes apparatus for inserting through the organ tissue a first row of suture elements having a first predetermined leg Iength and a first predetermined spacing
  • the apparatus for inserting a double row of the suture elements includes: apparatus for inserting through the organ tissue a second row of suture elements having a second predetermined leg Iength and a second predetermined spacing, and apparatus for inserting through the organ tissue a third row of suture elements, parallel to the second row, and having a third predetermined leg Iength and a third predetermined spacing, wherein the leg lengths and the spacings are predetermined to apply to the suture tissue a varying force along the entire suture predetermined so as to facilitate adequate blood supply to the suture tissue while not preventing haemostasis, thereby to facilitate optimal healing of the tissue.
  • the apparatus for selectably connecting also includes apparatus for aligning the anvil with the suturing apparatus such that the single and double rows of the recesses are aligned in registration with the single and double rows of suture elements.
  • the first step of stapling includes inserting through the first tissue portions a single row of suture elements
  • the second step of stapling includes inserting through the second tissue portions a double row of suture elements.
  • each suture element has a pair of legs arranged for transverse insertion through the organ tissue, and each step of stapling includes forcibly inserting the suture elements through the tissue and bending the legs down so as to cause them to become fastened to the tissue.
  • the first step of stapling includes inserting through the first tissue portions a first row of suture elements having a first predetermined leg Iength and a first predetermined spacing
  • the second step of stapling includes: inserting through the second tissue portions a second row of suture elements having a second predetermined leg Iength and a second predetermined spacing, and inserting through the third tissue portions a third row of suture elements, parallel to the second row, and having a third predetermined leg Iength and a third predetermined spacing.
  • the method further includes the step of predetermining the required leg lengths and spacings so as to apply a varying force along the entire suture while facilitating adequate blood supply to the suture tissue while not preventing haemostasis, thereby to facilitate optimal healing of the tissue.
  • Fig. 2A is cross-sectional view of the head portion and anvil of the suturing device of
  • Fig. 2B is a side-sectional view of the rear end of the suturing device of Fig. 1;
  • Fig. 2C is a cross-sectional view of a portion of the device seen in Fig. 2B, at line C-C therein;
  • Fig. 3A is a perspective view of a piston head forming part of the head portion of Fig. 2A;
  • Fig. 4A is a cross-sectional view of the head portion of Fig 2A, taken along line A-A therein;
  • Fig. 5 is a view corresponding to that of Fig. 4B, but showing a construction according to an alternative embodiment of the invention
  • Figs. 7A, 7B and 7C are schematic side views showing the suturing device of the present invention in various stages of use.
  • Outer partition 34 is disposed between a major portion of casing 24 and inner partition 32.
  • a second chamber 42 for a second plurality of suturing elements 44 is thus formed between the inner and outer partitions 32 and 34, and a third chamber 46 for a third plurality of suturing elements 48 is formed between outer partition 34 and casing 24. It will thus be appreciated that the second and third pluralities of suturing elements 44 and 48 are provided as a double row.
  • a circular blade 50 is also mounted onto piston head 27, and is provided for automatically cutting excess organ tissue at the time of suturing.
  • Pusher members 28 and 30 are disposed, as seen, within the first, second and third chambers. Activation of the handle 18 of the device 10, described below in conjunction with Figs. 2B and 2C, is operative to cause piston rod 26 to project pusher members 28 and 30 forwardly with respect to casing 24, thereby to cause ejection of the suturing elements from the chambers.
  • Anvil 22 has a rear-facing surface, referenced 52, which, as seen in Figs. 2A and 4B, has a plurality of recesses formed therein.
  • the recesses are provided as first, second and third pluralities, respectively referenced 40', 44' and 48', and are distributed so as to be in registration with the first, second and third pluralities of suture elements, and thereby to cooperate with them when the device is activated.
  • Rod 54 which is operatively connected to handle 18, and which extends through tubular housing 12 and ejection head 20.
  • Rod 54 has a front end portion 56 which is constructed for a snap-type connection with a rear end portion 58 of a stem element 60 formed on rear surface 52 of anvil 22.
  • front end portion 56 is shown in the drawings as a female connecting portion, having a pair of splayed arms 62 having inward-facing protrusions 64 formed at the free ends thereof.
  • Rear end portion 152 of the activating rod 54 has a generally rounded cross-sectional configuration, and has formed thereon an outward-facing screw thread 160, which is arranged for screwing engagement with screw thread 158.
  • Nut member 154 terminates in a handle portion 162, via a narrowed neck portion 164 which is engaged by rear wall 166 of rear housing 150, thereby to be prevented from axial translation.
  • rotation of handle 162 is operative to cause a corresponding axial translation of activating rod 54 and thus of front end portion 56 (Fig. 2A) thereof, so as to facilitate engagement of rear end portion 58 of stem element 60 of anvil 22 by front end portion 56. Subsequently, the clearance between ejection head 20 and anvil 22 can be adjusted as desired by appropriate rotation of handle portion 162.
  • Handle 18 is mounted for rotation about an axis 168, and is formed with an inward-projecting tooth, referenced 170.
  • Piston rod 26 has a recess 172, formed therein, and is arranged such that recess 172 is positioned in registration with tooth 170. Accordingly, depression of handle 18, achieved by squeezing it such that it rotates towards housing 150, as shown by arrow 174, causes a corresponding rotation of tooth 170 which, in turn, engages a rear-facing edge 176 of piston rod 26, thereby to causes a forward axial movement thereof, shown by arrow 178.
  • both the frequency and Iength of the suture elements are varied so as to take account of the suturing requirements of the different portions of tissue of the organ portions to be connected.
  • the lateral spacing between suture elements in the first, second and third pluralities varies directly with the distance between the portions of pusher members 28 and 30 in registration with the first, second and third pluralities of suture elements.
  • the suture elements in the third plurality 48 are required to provide, first and foremost, proper fixation of the tissue adjacent to the mesentery, while the second plurality of suture elements 44, located inwardly of the third plurality, primarily provides the required pressure so as to prevent bleeding, and thereby to allow haemostasis Accordingly, the suture elements 48 in the outside row have legs 49 which are relatively long, having a Iength L3, such that they can easily be inserted through the mesenteric tissue, and can provide the required fixation of this tissue, while the inner plurality of suture elements 44, while having shorter legs 45 of Iength L1, are more densely spaced, thereby to provide required sealing of the blood vessels
  • housing 12 has a generally bent configuration, and the second and third chambers 42 and 46 are provided on the concave side of the housing
  • housing 12 has provided thereon exterior markings along surface portions 80 and 82, including lines 84 and 86 These markings face towards the concave side of the housing 12, and, as the anvil 22 will already have been positioned such that the recesses for the second and third pluralities of suture elements face inwards, or towards the mesentery, the surface markings and lines provide a visual indication as to the orientation of the remainder of the device required so as to place the suture element pluralities in registration with their respective recesses Similar markings are also provided on surface portion 88 of the stem element 60
  • bowel ends 128' and 130' are partially closed about the suturing head 20 and anvil 22, respectively, by purse-string sutures, such that end portion 56 of rod 54 and stem 60 of anvil 22 remain protruding from the bowel portions.
  • the ends of the threads are attached to their respective hooks, of which only one, namely, hook 61 , is seen in the drawing.
  • nut member 154 (Fig. 2B) is rotated so as to cause an axial retraction retract rod 54, thereby to bring head portion 20 and anvil 22 together, such that the bowel ends 128' and 130' are pressed therebetween, defining a common interface 131.
  • handle 18 is rotated, as described above in conjunction with Fig. 2B, so as to extend piston rod 26 and thus pusher members 28 and 30, and blade 50 forwardly of casing 24.
  • suture elements 40, 44 and 48 This causes the suture elements 40, 44 and 48 to be extended across interface 131, through the bowel tissue and into recesses 40', 44' and 48' on anvil 22, such that the legs of the suture elements are bent inwards, thereby to connect the two bowel portions together.
  • the described extension of blade 50 is operative to cut off the excess tissue connected to device 10 by the purse- string sutures.
  • the double row of suturing elements constituted by second and third pluralities 44 and 48, used to suture the bowel tissues adjoining the mesentery, provide good fixation of the tissue portions, and apply enough pressure so as to provide good haemostasis thereat.
  • the pressure applied via the inner or second plurality of suture elements 44 is greater, due to the fact that the portion of pusher member 28 is relatively long, and the elements themselves are relatively short. This provides improved haemostasis thereby.
  • the greater Iength of the outermost row of suture elements 48 ensures that the pressure applied to the sutured bowel tissue thereby, while being sufficient to fixate the tissue properly, does not overly reduce the blood supply to these tissue portions. Accordingly, the tissue is permitted to heal properly with sufficient haemostasis, but without stenosis ands thus undesired formation of scar tissue.
  • the single row suture of the present invention facilitates a desired elasticity of the anastomosis and of the bowel lumen, thereby facilitating extraction of the entire surgical stapler 10, and, in particular, of the anvil 22. Furthermore, suture traumatization and the possibility of post-operative suture stenosis, are reduced.
  • the Iength of .the suture elements in first plurality 40 is selected to be between the Iength of the suture elements of the second and third pluralities 44 and 48, and the frequency of the first plurality 40 is selected to be greater than that of the third plurality of suture elements 48.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
EP19970907256 1996-03-21 1997-03-20 Chirurgisches klammergerät und verfahren zum chirurgischen befestigen Withdrawn EP0844847A4 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IL11760796A IL117607A0 (en) 1996-03-21 1996-03-21 Surgical stapler and method of surgical fastening
IL11760796 1996-03-21
PCT/IL1997/000104 WO1997034533A1 (en) 1996-03-21 1997-03-20 Surgical stapler and method of surgical fastening

Publications (2)

Publication Number Publication Date
EP0844847A1 true EP0844847A1 (de) 1998-06-03
EP0844847A4 EP0844847A4 (de) 2000-03-08

Family

ID=11068688

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19970907256 Withdrawn EP0844847A4 (de) 1996-03-21 1997-03-20 Chirurgisches klammergerät und verfahren zum chirurgischen befestigen

Country Status (3)

Country Link
EP (1) EP0844847A4 (de)
IL (1) IL117607A0 (de)
WO (1) WO1997034533A1 (de)

Families Citing this family (707)

* Cited by examiner, † Cited by third party
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WO1997034533A1 (en) 1997-09-25
IL117607A0 (en) 1996-07-23
EP0844847A4 (de) 2000-03-08

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