Endoscopic fastening system with multiple fasteners

• US 20050216036A1
• Filed: 03/25/2005
• Published: 09/29/2005
• Est. Priority Date: 03/29/2004
• Status: Abandoned Application

• Current Assignee: Granit Medical Innovations LLC
• Original Assignee: Granit Medical Innovations LLC
• Inventors: Nakao, Naomi L.
• Application Number:
  US11/090,718
• Publication Number:
  US 20050216036A1
• Time in Patent Office: Days
• US Class Current: 606/142
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery

Abstract

An endoscopic fastening system having a diameter sufficiently small so that the fastening system is slidably insertable into a working channel of a flexible or rigid endoscope for performing a stapling, clipping, or other fastening operation, comprises one or more fasteners, and a fastener delivery and deployment assembly. One or more fasteners being disposed in a substantially closed prefiring configuration inside the fastener delivery and deployment system are configured for being delivered and deployed into a target tissue while remaining in a substantially closed configuration throughout the entire operation. Other related embodiments of fasteners and their respective delivery and deployment assemblies enabling fastening operations in conjunction with a flexible or rigid endoscope are described.

Claims

1. An endoscopic fastening system for securing tissue internal to the body utilizing an endoscope, comprising:

an elongate fastener delivery and deployment assembly being provided at a distal end with forceps jaws and at the proximal end with an actuation mechanism for manipulating said jaws between an open and a closed position;

one or more surgical fasteners disposed inside said elongate fastener delivery and deployment assembly, said fasteners having a predetermined position relative to said jaws, said fastener being disposed in a substantially closed pre-firing configuration in said assembly proximally of said jaws prior to an opening of said jaws, said fastener having legs or prongs that are disposed at a predetermined distance from one another in said closed pre-firing configuration; and

a pusher rod member provided for advancing said fasteners in a distally directed motion of said pusher rod member,

at least one of said elongate fastener delivery and deployment assembly and said fastener having means for constraining said legs or prongs to have a spacing at all times at most as great as said predetermined distance, whereby said fastener may be moved in a substantially closed configuration into said jaws and from said jaws into target tissue.

2. The endoscopic fastening system in accordance with claim 1 wherein said fastener is constrained by internal stresses to maintain said predetermined distance between said legs or prongs, said fastener being deformable so that said legs or prongs may be brought into a fully closed postfiring configuration wherein said legs or prongs are spaced from one another by a distance smaller than said predetermined distance.

3. The endoscopic fastening system in accordance with claim 2, wherein a fastener bight portion is permanently deformable to produce said fully closed postfiring configuration.

4. The endoscopic fastening system in accordance with claim 1, wherein said assembly has an outer diameter sufficiently small to enable insertion of said assembly through a working channel of a flexible or rigid endoscope.

5. The endoscopic fastening system in accordance with claim 1 wherein said forceps jaws are configured for engaging a fastener when said jaws are in a partially closed configuration.

6. The endoscopic fastening system in accordance with claim 5, wherein said forceps jaws are provided with preformed grooves extending longitudinally on a medial aspect of an inwardly facing surface of at least one of said jaws.

7. The endoscopic fastening system in accordance with claim 1 wherein said forceps jaws are configured for approximating and/or clamping severed target tissue or other disparate segments of tissue.

8. The endoscopic fastening system in accordance with claim 7, wherein said forceps jaws are provided with flat surfaces extending longitudinally on a lateral aspect of an inwardly facing side of at least one of said jaws.

9. The endoscopic fastening system in accordance with claim 8, wherein said surfaces are provided with ridges configured for tissue approximation and/or clamping.

10. The endoscopic fastening system in accordance with claim 1, wherein said forceps jaws are provided with pointed tips, said tips being provided for tissue penetration.

11. The endoscopic fastening system in accordance with claim 1, wherein said legs or prongs are provided with pointed distal tips for facilitating tissue penetration.

12. The endoscopic fastening system in accordance with claim 1, wherein said fastener is provided with a closure means for maintaining said fastener in a fully closed post-firing configuration.

13. The endoscopic fastening system in accordance with claim 12, whereby said closure mechanism comprises a hook and slot mechanism.

14. The endoscopic fastening system in accordance with claim 12, whereby said closure mechanism comprises of a hinge mechanism.

15. The endoscopic fastening system in accordance with claim 12, whereby said closure mechanism is comprised of a spring mechanism.

16. The endoscopic fastening system in accordance with claim 1, wherein said fastener is one of a plurality of identical fasteners disposed in a partially closed prefiring configuration within a channel of a tubular member, said tubular member maintaining said fasteners in said partially closed prefiring configuration to form a fastener-magazine within said inner tubular member.

17. The endoscopic fastening system in accordance with claim 1, wherein said actuation mechanism is provided with a slide subassembly, said subassembly being configured for sliding along a shaft member.

18. The endoscopic fastening system in accordance with claim 17, further comprising a pusher rod member operatively connected to said slide subassembly so that sliding of said slide subassembly induces said pusher rod member to push a magazine of fasteners along said shaft member in a distal direction.

19. The endoscopic fastening system in accordance with claim 18, whereby said slide subassembly is provided with means to control each fastener'"'"'s separate delivery into said forceps jaws.

20. An endoscopic fastening system for securing tissue internal to the body, comprising:

an elongate fastener delivery and deployment assembly provided at a distal end with forceps jaws and at a proximal end with an actuation mechanism; and

a surgical fastener, said fastener comprising two legs and a bight portion joining said legs to one another, said fastener being disposed inside said elongate fastener delivery and deployment assembly, said fastener delivery and deployment assembly including an elongate shaft member provided with a channel extending longitudinally therethrough,

said channel housing one or more fasteners disposed in a magazine;

said fastener delivery and deployment assembly further including a pusher rod member slidably disposed inside said channel, said pusher rod member being provided for advancing fasteners in a distal direction along said shaft member;

said fastener delivery and deployment assembly further including forceps jaws provided with preformed grooves, and flat surfaces, said jaws being configured for engaging each fastener and approximating tissue respectively, said jaws being provided with pointed tips for easy tissue penetration; and

said actuation mechanism being provided for for at least one action taken from the group consisting of fastener positioning inside said forceps jaws, and effectuating said jaws alternately into opened and closed positions.

21. A method for performing surgical operations on internal body tissues of a patient, comprising:

(i) shifting a fastener delivery and deployment assembly in a distal direction towards target tissue, said assembly including forceps jaws disposed in an initial closed configuration at a distal end;

(ii) operating an actuator on said assembly to open said forceps jaws (iii) plunging the opened jaws into said target tissue;

(iv) after the plunging of the opened jaws into said target tissue, closing said forceps jaws to a first closed configuration, thereby causing tissue approximation;

(v) after the closing of said forceps jaws, advancing a first fastener in a distal direction into said forceps jaws in said first closed configuration;

(vi) squeezing said jaws into a second closed configuration wherein said jaws are nearer to one another than in said first closed configuration, thereby bringing said fastener into a fully closed postfiring configuration; and

(vii) after the squeezing of said jaws into said second closed configuration, opening said jaws, thereby releasing said fastener.

22. The method in accordance with claim 21 wherein said fastener is disposed in a closed pre-firing configuration in said assembly proximally of said forceps jaws prior to the opening of said jaws and is advanced into said jaws only after the plunging of said jaws into the target tissue, said fastener having legs or prongs that are disposed at a predetermined distance from one another in said closed pre-firing configuration, said legs or prongs being constrained to have a spacing at all times at most as great as said predetermined distance, whereby said fastener is inserted in a substantially closed configuration into the target tissue.

23. The method defined in claim 22 wherein said fastener is constrained by internal stresses to maintain said predetermined distance between said legs or prongs, the squeezing of said jaws inducing a crimping or deformation of said fastener so that said legs or brought into said fully closed postfiring configuration wherein said legs or prongs-are spaced from one another by a distance smaller than said predetermined distance.

24. An endoscopic fastening system comprising an elongate shaft member having an outer diameter sufficiently small to be slidably insertable through an endoscope, said shaft member being provided at a distal end thereof with a pair of forceps jaws, and at a proximal end with an actuation mechanism, a clevis subassembly disposed proximate a proximal aspect of said forceps jaws, said clevis subassembly being operatively coupled with said forceps jaws, said clevis assembly being provided with means to transform a fastener from an open to a closed configuration.

25. The endoscopic fastening system in accordance with claim 24, wherein said clevis subassembly is provided with a forming rail.

26. The endoscopic fastening system in accordance with claim 25, wherein said forming rail is configured for deforming a substantially closed fastener into an open fastener when said fastener traverses along said forming rail in the distal direction.

27. An endoscopic fastening system for securing tissue internal to the body utilizing an endoscope comprising:

an elongate fastener delivery and deployment assembly being provided at a distal end with forceps jaws and at the proximal end with an actuation mechanism for manipulating said jaws between an open and a closed position, one or more surgical fasteners disposed inside said elongate fastener delivery and deployment assembly, said fasteners having a predetermined position relative to said jaws, a pusher rod member provided for advancing said fasteners in a distally directed motion, an inner tubular member configured for housing one or more surgical fasteners disposed in predetermined positions constituting a fastener magazine; and

a clevis subassembly operably coupled proximate said forceps jaws, said clevis subassembly being provided with means for opening a partially closed fastener.

28. A method for fastening internal body tissues of a patient, comprising:

(i) inserting an endoscope into a patient'"'"'s body and is used to visually locate a target tissue to be operated upon;

(ii) inserting a fastener delivery and deployment assembly into a working channel of said endoscope and pushing said assembly in a distal direction towards a target tissue;

(iii) manipulating an actuation mechanism to open forceps jaws of said fastener delivery and deployment assembly and pushing said jaws proximate the target tissue;

(iv) advancing a fastener into said forceps jaws, said fastener being forced into an open position by forming rails;

(v) inserting the open forceps jaws with the open indwelling fastener into the target tissue;

(vi) closing said forceps jaws upon the fastener and the target tissue;

(vii) closing said jaws further to bring the fastener into a fully closed postfiring configuration; and

(viii) opening the forceps jaws to release said fastener after said fastener is brought into said fully closed postfiring configuration, said jaws being removed from the target tissue and extracted from the target tissue.

29. The method in accordance with claim 28, further comprising repeating steps (iii) through (viii) using a plurality of fasteners during a single intubation of the patient.

30. An endoscopic fastening system comprising a delivery and deployment assembly, said assembly including a tubular shaft member, and a spring biased surgical fastener disposed in said shaft member, said fastener being in an unstrained state when in a closed configuration.

31. The endoscopic fastening system in accordance with claim 30, wherein said fastener is configured from a spring biased material taken from the group consisting of plastic, surgical stainless steel, a shape memory material, and Nitinol (NiTi).

32. The endoscopic fastening system in accordance with claim 30, wherein said fastener is provided with a spring member, said spring member, when compressed, effectuates said fastener to assume an opened configuration.

33. The endoscopic fastening system in accordance with claim 32 wherein said spring member is constituted by a proximal bight portion of said fastener joined to legs or prongs of said fastener in a scissors or criss-crossing structure.

34. The endoscopic fastening system, in accordance with claim 30, wherein said shaft member is provided with a hard rigid collar-member having a restrictive lumen for compressing said fastener during a traversing of said lumen by said fastener.

35. The endoscopic fastening system in accordance with claim 34, wherein said restrictive lumen has inner diameter smaller than that of said tubular shaft member.

36. The endoscopic fastening system in accordance with claim 34, wherein said fastener is provided with a spring member, said spring member, when compressed, inducing said fastener to assume an opened configuration, wherein said inner diameter of said restrictive lumen is smaller than said spring member of said fastener.

37. The endoscopic fastening system in accordance with claim 34, wherein said restrictive lumen has a wider proximal opening contiguous with a channel of said tubular shaft member, said opening configured for guiding distal tips of said fastener into said collar member.

38. A surgical fastener provided with two or more prongs and with a spring portion biasing said prongs to a closed configuration, said spring portion being configured to cause said prongs to shift between from the closed configuration to an open configuration upon an application of a transverse compressive force to said spring portion.

39. The fastener in accordance with claim 38 wherein said spring portion is a loop at one end of said fastener, said prongs being continuous with said loop on opposite sides or ends thereof, said loop having a criss-crossed form.

40. A method for fastening internal body tissues of a patient, comprising:

(i) inserting an endoscope through an aperture in a patient'"'"'s body and using the endoscope to visually locate a target tissue to be operated upon;

(ii) inserting a fastener delivery and deployment assembly into a working channel of an endoscope and pushing the fastener delivery and deployment assembly in the distal direction proximate the target tissue

(iii) operating an actuation means to advance fasteners contained in said fastener delivery and deployment assembly towards a collar member having a restrictive lumen;

(iv) advancing said fastener through said restrictive lumen of said collar member, causing said fastener to assume an open configuration;

(v) pushing the open fastener into target tissue so that said fastener enters said target tissue; and

.

(vi) pushing said fastener further in the distal direction until said fastener is released from said restrictive lumen thereby enabling said fastener assume a postfiring closed configuration inside said target tissue.

41. A method for performing a surgical operation on internal body tissues of a patient, comprising:

(i) providing a plurality of surgical fasteners having holes or cavities proximate a proximal end, said fasteners being adjoined to one another by a suture thread, said fasteners being preloaded in pairs or in a magazine fashion;

(ii) applying said fasteners in pairs in organic tissue of a patient;

(iii) synching said suture thread together to provide tissue approximation and/or closure.

42. A surgical fastening instrument with jaws comprising distally rounded tips containing a magazine of staples with similarly rounded tips utilizable, for an example, for ligating tubular structures internal to a patient'"'"'s body, said fastening system being used in conjunction with an endoscope.