WO2012126477A1 - Fastening device, related tools and methods - Google Patents

Fastening device, related tools and methods Download PDF

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Publication number
WO2012126477A1
WO2012126477A1 PCT/DK2012/050084 DK2012050084W WO2012126477A1 WO 2012126477 A1 WO2012126477 A1 WO 2012126477A1 DK 2012050084 W DK2012050084 W DK 2012050084W WO 2012126477 A1 WO2012126477 A1 WO 2012126477A1
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WO
WIPO (PCT)
Prior art keywords
clip
jaw members
locking member
fastening device
tool
Prior art date
Application number
PCT/DK2012/050084
Other languages
French (fr)
Inventor
Regnar Bøge ARNESEN
Original Assignee
Herlev Hospital
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 Herlev Hospital filed Critical Herlev Hospital
Publication of WO2012126477A1 publication Critical patent/WO2012126477A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122Clamps or clips, e.g. for the umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery

Abstract

The present invention concerns a fastening device having an improved fastening mechanism, related tools, and related methods.

Description

Fastening device, related tools and methods Field of invention The present invention relates to a fastening device having an improved fastening mechanism, related tools, and related methods.
Background of invention Laparoscopic surgery is performed through cavity access-ports that are placed in small incisions. At least two long instruments and a camera are introduced through these ports. The technique is mainly used for interventions in the abdominal and thoracic cavity. When performed in the abdominal cavity, carbon monoxide is inflated to create a space between the viscera and the abdominal wall. Because this technique limits the surgical trauma, minimizes the scars and the period of recovery, minimally invasive techniques continue to develop and expand. Recent advances include robotic surgery, surgery trough specially designed ports leaving only one scar, and surgery with flexible endoscopes trough the mouth and stomach or other natural orifices, so called Natural Orifice Transluminal Endoscopic Surgery (aka NOTES).
Traction on tissue, hereunder the surface of an organ, is a fundamental criterion for successful and safe surgery. Only trough traction on tissue can important anatomical structures be exposed and dissected. However, achievement of the appropriate traction on tissue during laparoscopy and other minimally invasive procedures is a challenge because of the limited space, the limited mobility of the instruments due to fixed positions of the ports, and the small diameter of the instruments.
The following references describe tools and devices that may be used in surgery procedures.
WO 2009/094078 A2 describes a clip for use during surgical procedure provided with a sleeve-like enveloping compression spring. The clip may be used for grabbing an internal organ or tissue via jaws and the clip has a hook that can be used for anchoring. However, an amount of free space is needed between the compression spring and the jaws to facilitate movement of the compression spring. Therefore, the clip has problems in respect to clamping thin objects, such as thin tissue and the like. A clip, having a compression spring with a small internal diameter and therefore having narrow space between the compression spring and the jaws, has difficulties in moving between an open and a closed configuration because of friction. In addition, the compression spring is limited to its own spring force in relation to bringing the jaws of the clip together. Further, the spring may become inflexible when aged whereby its function is reduced. In addition, the compression spring is integrated with the clip and is therefore not easily removed in case of malfunction or replacement.
US 2009/192527 A1 discloses an anchoring tool for anchoring an organ. The anchoring tool may be connected to a pulling element which is fixable to the abdominal wall in such a way that it makes it possible to lift and keep the organ in a suspended position by the anchoring tool. Further, the anchoring tool may pass through a laparoscopic or coelioscopic trocar. The anchoring tool can be attached to a suture for traction and the anchoring tool can grab an object. However, in order to open the anchoring tool (prior to attachment or to release the anchoring tool), the surgeon has to apply a precise force to the "bearing disks" of the anchoring tool - an act which is cumbersome to the surgeon.
WO 2009/019288 A2 describes a surgical instrument incorporating the usage of magnets for application in minimally invasive surgery to perform abdominal surgery. The device may be used for performing cholecystectomy (gallbladder removal).
WO 03/059173 A1 discloses a device for suturing an opening in an internal organ of a patient, which includes anchoring members that may be advanced by a catheter by which the distal-most one of the anchoring members is driven out of the catheter to anchor in tissue.
Summary of invention
A problem with the known fastening devices is that the grip of the tissue portion is either too soft, thereby risking that the grip is lost, or the grip too firm, thereby possibly causing damage to the sensitive tissue. An object of the invention is therefore to provide a fastening device for clamping a tissue portion having an improved fastening mechanism. Further, existing laparoscopic graspers depend on access trough a laparoscopic port thus requiring an incision and leaving a scar. A further object of the invention is therefore to provide a fastening device that circumvents this problem.
The objects of the invention are achieved by a clip for gripping a portion of tissue, comprising at least a first and a second jaw member connected to each other at proximal ends thereof, and a locking member adapted bring the jaw members together when said locking member is engaged with the proximal ends of the jaw members by a suitable tool, wherein the enveloping force exerted by the locking member is adjustable depending on the position of the locking member relative to the jaw members.
Preferably the locking member is adapted for retaining a plurality of positions relative to the jaw members. The enveloping force exerted by the locking member is proportional with the pinching effect of the clip. Thus, the pinching effect of the clip is adjustable depending on the position of the locking member relative to the jaw members. The clip is preferably self-opening, i.e. in a configuration where the locking member is not engaged with the jaw members, the jaw members will form an open clip.
A further object of the invention is to provide a tool that enables control of the clip, in particular enabling control of the fastening mechanism. This object is achieved by an tool adapted for this clip, said tool comprising a driving member adapted for engagement with the locking member of the clip such that the locking member can be engaged with the proximal ends of the jaw members of the clip by means of the driving member. The driving member is preferably adapted to adjust the position of the locking member relative to the jaw members. Preferably the driving member is adapted to arrange the locking member in a plurality of positions relative to the jaw members.
By the clip and the related tool according to the invention the clamping force exerted by the clip can be controlled by means of adjusting the position of the locking member. As the position of the locking member at least partly determines the enveloping force of the jaw members, the grip of the clip can be adjusted and adapted in any specific situation, and in particular be adjusted and adapted to the type and condition of the tissue. The clip according to the present invention may also be termed "laparoscopic clip", "surgical clip", "anchoring clip" or "endoscopic clip". Equivalently the tool may be termed "introducer", "laparoscopic tool", "surgical tool", "anchoring tool", "endoscopic tool", "applicator", "clip applicator", "laparoscopic clip applicator" etc.
The invention further relates to a surgery device (or laparoscopic device) comprising the clip and the tool according to the invention.
Detailed description of the clip
In one embodiment of the invention the locking member is envelopingly engaged with the jaw members. Further, the locking member may be resilient. Even further, the locking member may be adapted to be expanded in diameter and thereby adapted to exert forces towards the jaw members such that the jaw members are brought together as said resilient locking member is envelopingly arranged with the at least first and second jaw members. Thus, the first and second jaw members may have a form so that the resilient locking member is adapted to exert forces towards the jaw members.
In another embodiment of the invention the first jaw member comprises a first distal portion and a first proximal portion so that a first axis passes through the first distal portion and the first proximal portion, whereby a first direction along the first axis is directed in the direction from the first proximal portion to the first distal portion, and wherein the second jaw member comprises a second distal portion and a second proximal portion so that a second axis passes through the second distal portion and the second proximal portion, whereby a second direction along the second axis is directed in the direction from the second proximal portion to the second distal portion, and whereby a third axis is lying between the first axis and the second axis so that a third direction along the third axis is directed in a direction lying between the first and second directions.
The clip may be formed by having the first and second jaw members (i.e. the jaw members) being connected by means of a connecting portion. The self-opening function of the clip may be effected by a resilient connecting portion. Further, the connecting portion may comprise a tension spring member. In one embodiment of the clip according to the invention the locking member is adapted to at least partially envelop matching portions of the first and second jaw members. Thus, the shape of the locking member may be adapted to matching portions of the jaw members.
In one embodiment of the clip according to the invention the locking member and the jaw members are adapted for stepwise engagement with each other. Preferably each step corresponds to a different position of the locking member and thus with a plurality of possible steps the locking member may retain a plurality of positions relative to the jaw members. Thus, the position of the locking member relative to the jaw members may be stepwise adjustable, and thereby the clamping force of the clip may be stepwise adjustable. Step wise adjustment may be provided if the outer surfaces of the proximal end of the jaw members comprise protrusions and/or grooves, preferably extending in a substantially cross-sectional direction, and the locking member correspondingly comprises matching side protrusions and/or grooves. Such side protrusions and/or grooves may be advantageous in securing the locking member to the jaw members. In one embodiment, the jaw members comprise at least one projection, such as barbs, extending backwards for securing the locking member from unhooking. The clip may thus be adapted to retain an irreversible closed configuration.
In a further embodiment of the clip, the position of the locking member relative to the jaw members is continuously adjustable and thereby the clamping force of the clip may be stepwise adjustable. In a further embodiment of the clip the position of the locking member relative to the jaw members is adjusted by rotating the locking member. I.e. the locking member may be adapted for rotatable engagement with the jaw members. A rotatable engagement is an example of a solution that enables a continuously adjustable position of the locking member.
In one embodiment of the clip according to the invention the locking member is engaged to the jaw members by means of fastening means. Fastening means such as threads, e.g. the locking member and the jaw members may be provided with matching threads for rotatable engagement of the locking member with the jaw locking members. In a further embodiment the threads provided on the jaw members extend only partially around the circumference of the proximal ends of the jaw members. The clip is preferably adapted to be enclosed in some sort of introducer / tube. A thread provided on the outside of the jaw members may provide resistance when the clip guided out of the tube or retracted into the tube, especially is the clip is at least partly open a thread may rub against the edge of the opening / bore / aperture of the tube. Thus, if the thread does not extend all around the circumferences of the jaw members there may be a part of the outer surface of the jaw members that is not threaded. Thus, at least a part of the outer surfaces of the proximal ends of the jaw members may be smooth. The smooth surface may help to ensure that the outer surface of the jaw members rubs can glide against the inner edge of a tube opening.
In one embodiment of the clip the inner diameter of the locking member is gradually varying, i.e. the inside of the locking member may be tapered. This may help to ease the engagement of the locking member with the jaw members, especially if the jaw members are in a substantially open configuration. In the case of a thread provided inside the locking member, the diameter of the thread may be gradually increasing.
In a further embodiment of the clip the jaw members are tapered towards the proximal end, i.e. the cross sectional area of the first and second jaw members is varying.
Preferably the cross-sectional area of the jaw members is gradually increasing from the proximal end towards the distal end of said jaw members. This may also help to ease the application of the locking member because the locking member will be applied at the proximal end of the jaw member, i.e. the end of the jaw members which has the smallest diameter. Further, the first and second jaw members may be adapted for pivotally engagement.
In a further embodiment of the invention the clip comprises an attachment part, preferably extending from the proximal end of the jaw members. The attachment part is provided as a portion of the clip which is suitable for engaging with the locking member, i.e. the locking member is adapted to engage with the attachment part. Preferably the locking member is engaged with the attachment by means of fastening means. And further the locking member is preferably adapted for rotatable engagement with the attachment part. Thus, the locking member and the attachment part may be provided with matching threads for rotatable engagement of the locking member with the attachment part. Providing this attachment part is an alternative to letting the locking member directly engage with the jaw members. I.e. in case the jaw members are in a substantially open position it may be difficult for the locking member to engage with the jaw members. As stated elsewhere this may be solved by having a tapered proximal portion of the jaw members and/or by having an larger inner opening of the locking member towards the jaw members. By having an attachment part that does not change open, i.e. the cross-sectional area of the attachment part does not increase when the clip is open, it is straightforward to engage the locking member with the attachment part. The locking member is then moved along the attachment part, i.e. by rotating along a thread, before engaging with the jaw members to close the clip. An example of an attachment part can be seen in fig. 9.1 .
In the preferred embodiment of the clip the locking member is adapted to be engaged by a matching driving member of a suitable tool. Thus, the locking member may comprise an engagement portion adapted for matching a corresponding engagement portion of a driving member of a suitable tool. The engagement portions may comprise one or more protrusions, notches and/or grooves.
A further embodiment of the clip according to the invention comprises a grasping portion adapted for being grasped by a suitable tool. The grasping portion may be adapted for being grasped by a hook shaped tool. The grasping portion may be part of the connecting portion, e.g. if the connecting portion forms a loop protruding from the proximal end of the jaw members.
In one embodiment of the clip according to the invention, the locking member comprises a tension spring member. A tension spring member, such as a rubber band, which is designed to become longer under load is advantageous in that the force applied for bringing the first and second jaw member together can be varied according to how much the tension spring is extended. The force exerted can thus be controlled in a very precise way. For instance, if the resilient locking member is pressed onto the jaw members, a weak force can be applied when the resilient locking member is close to the proximal portions while a strong force can be applied when the resilient locking member is pushed further onto the jaw members. The force applied is therefore highly adjustable as the position of the resilient locking member can be varied according to different anchoring situations, e.g. according to the thickness and slipperiness of the tissue to be gripped. The clip may comprise at least one attachment means for attaching at least one traction member. The at least one attachment means may for instance comprise a hook, loop, arch, or eye member, and the at least one traction member may comprise a wire member, a suture, or the like. In a related embodiment at least one of the jaw members comprises at least one traction member receiving portion adapted for receiving and securing at least one traction member. The clip may be adapted so that the traction member receiving portion may receive and secure at least one traction member at the same time as the clip is secured to a tissue portion or the like. The clip may also comprise means for guiding and/or catching a traction member in cooperation with the receiving portion. The means for guiding or catching may comprise first and/or second projection member(s) that protrude in a direction substantially perpendicular to respectively the first and second axes described above. The clip may thereby be adapted for anchoring and may constitute an anchoring device.
The clip may comprise an active opening mechanism and/or an active closing mechanism. The clip may for instance comprise an active opening mechanism so that the jaw members are forced from each other, e.g. by a spring, when no closing force is applied, i.e. the clip is self-opening. Such an active mechanism may exert forces that work against the forces exerted by the locking member. Alternatively, the clip may comprise an active closing mechanism, such as a mechanism known from laundry clothespins that may work together with the locking member.
The clip according to the invention may comprise a string or suture linking a needle with the device. In use, the clip may grab an inner organ and the needle and string pass out through the patient's abdominal wall. Once outside, the surgeon controls the organ's position by means of the string. In a preferred embodiment the clip may thus grab the inner organs in a mechanical way. Further, the clip may include first and second tissue gripping ends coupled to a spring member biased to bring the ends toward one another to grasp tissue received there between by bending the spring member.
A length of suture can extend from a suture attachment means, such as a loop and may couple the anchoring member to other anchoring members for instance for pulling by a surgeon. In addition, the clip may include abutting members that contact one another in order to prevent distal gripping ends of the device from coming together and severing the gripped tissue. At least one pulling member can be fastened to the clip, such that traction, e.g. through the abdominal wall, can be performed in such a way that it is possible to lift and keep an organ or the like anchored by the clip in suspended position whereby laparoscopy or coeloscopy may be performed.
A tool may be used for manipulating the clip, e.g. for grasping or releasing grasped tissue. The size of the tool and the clip is preferably selected in such a way that it may pass through a laparoscopic or coelioscopic trocar. The clip may thus be used for anchoring an organ of a living being, for use in order to expose an anatomical structure during a surgical operation, in particular using laparoscopy or celioscopy. In order to perform surgery using laparoscopy or celioscopy, it is known to artificially inflate the abdomen of a human being or an animal on which an operation is to be performed with gas, and then to introduce trocars through the abdominal wall so as to create sealed entry ports to the operation space. The anatomical region on which an operation is to be performed can be viewed by the surgeon using a special camera introduced into the operation space through a trocar. The anatomical region on which an operation is to be performed can thus be exposed by one or two surgeon's assistants who move away the organs that are located in front of the operation region using the clip according to the invention. In some operations, a surgeon's assistant can be replaced by a robotic arm. The device according to the invention may be used passing through the abdominal wall via trocars implanted therein. Implanting each trocar requires an incision to be made in the abdominal wall. However, preferably only a limited number of trocars are implanted, as to reduce the number of scars that result from an operation.
The clip may comprise an arch or a loop for attaching at least one traction member, such as a suture, a wire, a thread, a string, a strip, a strap, etc. The traction element may be secured to the abdominal wall in order to raise and keep in suspension an organ held by the clip. The traction element is preferably attached to the distal end of the clip, i.e. the distal end of the jaw members. The traction element can also be secured to the clip at the end opposite the jaw members.
The clip is preferably made of a suitable material, such as a material in the following non-limiting list: a plastic material, a metal, an alloy, a composite material, or a fibre reinforced material. In one embodiment, the clothespin is disposable and in another embodiment, the clip is made for repeated use. In repeated use, the clip may preferably be adapted for being sterilized.
Further embodiments of the clip
A further embodiment of the invention relates to a clip for gripping a portion of tissue comprising
at least a first jaw member having a first distal portion and a first proximal portion so that a first axis passes through the first distal portion and the first proximal portion, whereby a first direction along the first axis is directed in the direction from the first proximal portion to the first distal portion,
at least a second jaw member having a second distal portion and a second proximal portion so that a second axis passes through the second distal portion and the second proximal portion, whereby a second direction along the second axis is directed in the direction from the second proximal portion to the second distal portion, and whereby a third axis is lying between the first axis and the second axis so that a third direction along the third axis is directed in a direction lying between the first and second directions,
a connecting portion, and said at least first and second jaw members being connected through the connecting portion, wherein a resilient locking member is adapted to at least partially envelop matching portions of the at least first and second jaw members, and wherein the first and/or second jaw members have/has a form so that the resilient locking member is adapted to exert forces towards the jaw members such that the jaw members are brought together as said resilient locking member is envelopingly arranged with the at least first and second jaw members by a suitable tool.
In a related embodiment, there is provided a clip for gripping a portion of tissue, comprising at least a first jaw member having a first distal portion and a first proximal portion so that a first axis passes through the first distal portion and the first proximal portion, whereby a first direction along the first axis is directed in the direction from the first proximal portion to the first distal portion, at least a second jaw member having a second distal portion and a second proximal portion so that a second axis passes through the second distal portion and the second proximal portion, whereby a second direction along the second axis is directed in the direction from the second proximal portion to the second distal portion, and whereby a third axis is lying between the first axis and the second axis so that a third direction along the third axis is directed in a direction lying between the first and second directions, a connecting portion, and said at least first and second jaw members being connected through the connecting portion, wherein a resilient locking member is adapted to envelop matching portions of the at least first and second jaw members, and wherein the first and/or second jaw members have/has a form so that the resilient locking member is adapted to exert forces towards the jaw members such that the jaw members are brought together as said resilient locking member is envelopingly arranged with the at least first and second jaw members by a suitable tool.
In a preferred embodiment, the resilient locking member is adapted to be expanded in diameter and thereby adapted to exert forces towards the jaw members such that the jaw members are brought together as said resilient locking member is envelopingly arranged with the at least first and second jaw members. In one embodiment, the resilient locking member, such as a rubber or a plastic band, is thus designed to become longer under load in contrast to a compression spring that is designed to become shorter when loaded. The resilient locking member may also be made of materials which are harder and/or more rigid than a rubber band, such as a metal, a fibre-reinforced material or a composite material. By the term 'resilient' is meant that the locking member comprises any material which can exert forces towards the jaw members such that the jaw members are brought together as the locking member is envelopingly arranged with the jaw members. In one embodiment, the resilient locking member is adapted to at least partially envelop matching portions of the jaw members, however, it is preferred that the resilient locking member is adapted to envelop a circumferential portion of the clip. Preferably, the circumferential portion corresponds to an inner side portion of the resilient locking member, such as the inner side of a rubber band or the like. Preferably, the resilient locking member comprises a circumscribing object and preferably the the resilient locking member has a cylinder shape or a ring shape. However, in another
embodiment, the resilient locking member is partly cylinder-shaped or ring-shaped, such as having a C-shaped cross section. The resilient locking member may thereby envelop a part of a circumferential portion of the clip. In another embodiment, the resilient locking member has a clamping shape so that the resilient locking member may bring the jaw members together by clamping as it is envelopingly arranged with the jaw members. The resilient locking member may for instance have at least two clamping members, such as two arms for clamping, which are adapted to exert forces towards the jaw members as the clamping members are envelopingly arranged with the jaw members. The clamping members may for instance engage with the jaw members at matching portions. Preferably at least a first and a second clamping member is adapted to engage, respectively, with a first and a second matching portion of the jaw members. By the term 'matching portions' of the at least first and second jaw members is meant portions which are adapted to engage with the resilient locking member. The matching portions may be at least a part of the proximal portions, the distal portions, or the portions between the proximal and distal portions, or any combinations of the above mentioned portions. Preferably, the matching portions comprise circumferential portions of the jaw members.
Preferably, the first distal portion of the first jaw member is adapted to cooperate with the second distal portion of the second jaw member so that the clip may grasp, grip, or hold a portion of tissue or the like between the first distal portion and the second distal portion. In addition, the first proximal portion of the first jaw member may preferably comprise a portion adapted to cooperate with the second proximal portion of the second jaw member, for instance adapted for pivotally cooperation. Further, at least one of the jaw members and the connecting portion may be integrated. The connecting portion may constitute a joining portion for joining the jaw members. Preferably the connecting portion comprises a hinging portion and preferably the jaw members are adapted for hinging by means of such a hinging portion.
The first and second axes may cross at a pivoting point and the resilient locking member may preferably exert forces towards the jaw members in directions
substantially perpendicular to the first and second axis, such as in directions substantially perpendicular to the third axis lying between the first and second axis, where the angle between the third axis and the first axis preferably is equal to the angle between the third axis and the second axis. Further, the first and second proximal portions may constitute an end portion, such as a back end of the clip, which is adapted for receiving the resilient locking member. The clip may thus preferably have a V-shape. In one embodiment, the clip comprises an anchoring device, and the clip may constitute a clip or a clamp.
Another aspect of the invention relates to a clip for gripping a portion of tissue, comprising:
at least a first jaw member having a first distal portion and a first proximal portion so that a first axis passes through the first distal portion and the first proximal portion, whereby a first direction along the first axis is directed in the direction from the first proximal portion to the first distal portion,
at least a second jaw member having a second distal portion and a second proximal portion so that a second axis passes through the second distal portion and the second proximal portion, whereby a second direction along the second axis is directed in the direction from the second proximal portion to the second distal portion, and whereby a third axis is lying between the first axis and the second axis so that a third direction along the third axis is directed in a direction lying between the first and second directions,
a connecting portion, and said at least first and second jaw members being connected through the connecting portion, wherein a resilient elongated projecting locking body protrudes from the first jaw member in a direction substantially perpendicular to the first axis, said elongated projecting locking body being adapted for engagement with a matching first opening of the at least second jaw member, and said elongated projecting locking body and/or said matching first opening comprising a locking means so that the elongated projecting locking body is adapted to exert forces to the jaw members such that the jaw members are brought together as said elongated projecting locking body is received by the matching first opening.
Preferably the matching first opening extends curvily into the second jaw member in a direction substantially perpendicular to the second axis to a direction which is substantially directed in the second direction. Alternatively, the first opening may extend curvily into the second jaw member in a direction substantially perpendicular to the second axis to a direction which is substantially opposite to the second direction.
The locking means may comprise protrusions and/or grooves, such as notches, arranged with the elongated projecting locking body and/or the matching first opening. The elongated projecting locking body and/or the matching first opening may for instance comprise serrations and/or barbs. Preferably, the clip acquires a closed configuration as the matching first opening receives the elongated projecting locking body. The protrusions and/or grooves arranged with the elongated projecting locking body and/or the matching first opening may cooperate so that the elongated projecting locking body is hindered from moving out of the matching first opening after it has been received by the matching first opening.
The at least second jaw member may comprise a supporting second opening adapted for housing the elongated projecting locking body. The supporting second opening may advantageously house the elongated projecting locking body while the clip is in an unlocked configuration and thereby reduce the spatial size of the clip. When the clip is ready to grasp a suitable object, the elongated projecting locking body is moved out of the supporting second opening and into the matching first opening. Preferably, the supporting second opening extends curvily into the second jaw member in a direction substantially perpendicular to the second axis to a direction substantially opposite to the second direction. Preferably, the second jaw member comprises an matching first opening and a supporting second opening and preferably said first opening extends curvily into the second jaw member, in a direction substantially perpendicular to the second direction to a direction which is substantially directed in the second direction, while the supporting second opening extends curvily into the second jaw member, in a direction substantially perpendicular to the second axis to a direction substantially opposite to the second direction.
Tool
As further stated the present invention further relates to a tool adapted for the above mentioned clip, said tool comprising a driving member adapted for engagement with the locking member of the clip such that the locking member can be engaged with the proximal ends of the jaw members of the clip by means of the driving member. The driving member is preferably adapted to adjust the position of the locking member relative to the jaw members. Preferably the driving member is adapted to arrange the locking member in a plurality of positions relative to the jaw members. Operation of the driving member may thereby control the pinching effect of the clip. The preferred embodiment of the tool according to the invention is adapted to both 1 ) deliver, e.g. into the abdomen, and fasten the clip to an internal organ, and 2) release the clip from the organ and retract the clip, e.g. out of the abdomen.
In one embodiment of the tool the position of the locking member is adjusted by rotation of the driving member. Further, the driving member may comprise an engagement portion adapted to match an engagement portion of the locking member. The engagement portion of the driving member and the engagement portion of the locking member may be configured such that locking member is suitable for being retained by the driving member, e.g. by using magnetic attachment and/or tongue and groove joint and/or snap joint. This is to reduce the risk of loosing the locking member during surgical operation, i.e. when the locking member is not engaged with the clip it can be retained by the driving member.
In a further embodiment the tool comprises a tube attached to a handle and a guiding rod for guiding the clip, wherein the tube at least partly encloses the driving member and the guiding rod, and wherein the driving member and the guiding rod are operable / controllable from the handle. Preferably the guiding rod and the driving member are arranged concentrically in the tube. The guiding rod and the driving member are preferably arranged to be movable independently. Further, the guiding rod and/or the driving member may be arranged to be slidably movable inside the tube. And even further the guiding rod may be arranged to be slidably movable inside the driving member.
The guiding rod may comprise grasping means for gripping the clip, e.g. a hook shaped portion on the guiding rod suitable for gripping a loop shaped portion of the clip. And further, the opening of the tube may substantially match the cross-sectional area of the jaw members in the closed configuration. Thus, in one embodiment of the tool the guiding rod and the tube are arranged such that pulling the self-opening clip into the tube by means of the guiding rod brings the jaw members of the clip closer together.
Thus, all in all, the tool according to the present invention may be adapted for guiding, delivering, fastening, loosening and retracting the clip.
Further embodiments of the tool Further embodiments of the invention relates to tools that are specifically adapted for delivering and fastening the clip (entry tools) and tools that are specifically adapted for releasing and retracting the clip (exit tools). Entry tool
In a another aspect of the invention it is an object to provide a tool specifically adapted for guiding and/or delivering and/or fastening a clip, said tool comprising a driving member adapted for engagement with a resilient locking member so that the resilient locking member can be arranged envelopingly with at least first and second jaw members of the clip. Preferably, the driving member is provided at least partly inside a housing, which also at least partly houses the clip, such that the clip can be supported by the housing as the resilient locking member is be arranged envelopingly with at least first and second jaw members by the driving member.
In one embodiment of the tool, the resilient locking member is arranged envelopingly with the at least first and second jaw members as the driving member is moved in the third direction, such as moved towards the distal portions of the jaw members. The driving member is preferably adapted for pushing the resilient locking member onto the jaw members. In addition, the driving member may comprise a first engagement portion, and said first engagement portion being adapted for engagement with a matching second driving engagement portion of a resilient locking member which is adapted to be arranged envelopingly with the clip. The first engagement portion may comprise a surface which is directed substantially in the third direction as the resilient locking member is arranged envelopingly with jaw members of the clip by means of at least the driving member. The third direction may for instance comprise a direction towards a point lying between the distal portions of the jaw members of the clip. Further, the first engagement portion may have the shape of an annulus. The shape may for instance comprise a ring shaped end surface of a hollow cylinder.
The tool for guiding and attaching a clip may also comprise at least one support member for supporting the clip while the resilient locking member is arranged with the at least first and second jaw members. The support member may comprise a housing, such as a cylinder shaped housing, such that the clip can be ejected at least partly whereby the jaws are moved from each other. The clip is preferably in a closed configuration inside or partly inside the housing. The clip may thereby acquire an open configuration so that the jaw members are adapted for grasping tissue or the like. Further, the jaw members can then be brought together by bringing the clip into the housing, such that tissue or the like is clamped between the jaw members, and subsequently the resilient locking member can be arranged with the jaw members, preferably by at least one driving member, which is also preferably housed by the support member. The jaw members may for instance be partly enclosed by the housing while the resilient locking member is arranged with the jaw members.
In one embodiment, the tool comprises a housing adapted for housing at least a portion of the driving member and/or at least one resilient locking member and/or at least a portion of the clip. The housing may house a number of resilient locking members and clips, which are preferably in a closed configuration inside the housing. In addition, the housing may house a means for supplying a traction member, such as a wire, that is connected to or adapted to be connected to the clip. The tool may comprise a guiding rod adapted for guiding the clip. The guiding rod may be elongated and may have a bend in its distal end, said bend having an angle of approximately 90 degrees. In a preferred embodiment, the guiding rod has an engagement portion adapted for engagement with a matching engagement portion of the clip. The matching portion of the clip may for instance comprise an opening. The guiding rod is preferably adapted for moving, such as pushing or pulling, the clip out of or into a housing. The housing may be adapted to eject at least one clip. The clip may have an active opening mechanism so that the jaw members of the clip are moved from each other as the clip is ejected from the housing.
Exit tool In another aspect of the invention there is provided a tool specifically adapted for changing the configuration of a resilient locking member which is envelopingly arranged with a clip. The tool may also be specifically adapted for removing and/or extracting a resilient locking member. The tool may comprise at least one grasping member, said at least one grasping member having at least one first engagement portion which is adapted for engagement with a matching second grasping engagement portion of a resilient locking member, and said resilient locking member being adapted to be arranged envelopingly with the jaw members of the clip.
In a preferred embodiment, the tool comprises at least one catching member, such as a suture-catcher, adapted for engagement with at least one traction member, such as a suture, a wire, a thread, a string, a strip, a strap or the like, so that at least a portion of the at least one traction member can be moved to a predetermined location. Preferably the catching member comprises a hook-shaped rod, and preferably the catching member is adapted to move at least a portion of the traction member into a support housing. The support housing may for instance have the form of a cylinder, and the catching member is preferably adapted for slidably movement with the support housing. Preferably, the catching member is adapted for being kept at least partly inside the support housing when not in use and in use it is being adapted for sliding at least partly out of the housing so that it may engage with at least one traction member and return into the support housing with at least a portion of the traction member(s) so that at least a portion of the traction member(s) can be retained in the support housing. Traction member(s) may thereby be moved to location(s) where the traction member(s) does not hinder other procedures and the catching member may also prevent that traction member(s) or a clip/clips, attached to the traction member(s), are lost for instance inside the abdomen of a patient.
In one embodiment, the at least one first engagement portion comprises at least one first surface which is directed in a direction opposite the third direction. The first surface may for instance be directed towards the proximal portions of the jaw members. In a related embodiment, the at least one first surface is at least partly shaped as an annulus. Preferably, the at least one first surface comprises two surfaces each having half circular annulus shapes.
The first engagement portion may be adapted for engagement with a matching grasping engagement portion of a resilient locking member, which is arranged envelopingly with jaw members of the clip, such that the resilient locking member is adapted to be moved, by means of the at least one grasping member, in a direction opposite the third direction. In addition, the at least one grasping member may be capable of enveloping a resilient locking member which is arranged envelopingly with jaw members of the clip. Furthermore, the at least one grasping member may comprise at least a first cylinder portion and at least a second cylinder portion. The at least one grasping member may for instance comprise a plurality of cylinder sections, such as two cylinder sections, which are connected proximally to a common portion of the at least one grasping member. The cylinder sections may be adapted for being brought together or moved from each other. Preferably, the distal portions of the cylinder sections are adapted to be moved farther from each other compared to portions of the cylinder sections which are closer to the common portion. In particular, the at least one grasping member may comprise a plurality of hollow cylinder sections. In a preferred embodiment, the at least one grasping member is adapted to extend from the inside of a support housing. Preferably, the support housing is tube formed, such as having the form of a cylinder. In another preferred embodiment, the at least one grasping member is adapted to be slideably moved at least partly into and/or out of the support housing.
In a preferred embodiment, the at least one grasping member comprises at least one first portion which is adapted to expand in radial directions when the at least one grasping member is moved out of the support housing. The first portion may for instance comprise a resilient portion. The at least one grasping member may expand because of potential spring force energy which is released as the at least one grasping member is moved out of the support housing. The at least one first portion may have an engagement portion for engagement with a support member, so that the support member is adapted to move the at least one first portion in directions opposite radial directions, as the support member is moved substantially in the third direction and/or as the at least one grasping member is moved substantially in an opposite direction. The at least one grasping member is hereby adapted for seizing/grasping a resilient locking member which is arranged envelopingly with jaw members of the clip, and the at least one grasping member may thus change the configuration of the resilient locking member for instance by moving the resilient locking member in a direction substantially opposite to the third direction. Preferably, the at least one first portion is adapted to be slideably moved into and/or out of the support member.
In a preferred embodiment, the at least one first portion comprises a stopping means adapted for engagement with the support member so that the at least one grasping member is prevented from being fully enclosed by the support member. The stopping means may comprise at least one surface portion directed substantially in the opposite direction of the third direction. Preferably, the at least one surface portion is at least partly shaped as an annulus. The at least one surface portion may thus have a half circular annulus shape. Preferably, the surface portion is adapted for engagement with a matching engagement portion of the support member. Preferably, the engagement portion of the support member has the shape of an annulus, such as the ring shaped end surface of a hollow cylinder.
Methods
In a second aspect of the invention, a method for a surgical procedure is provided comprising the steps of: a) Inserting a fastening device into a body part;
b) Arranging a resilient locking member with the fastening device so that the fastening device grips a portion of tissue or the like.
Further, according to a related embodiment, a method is provided comprising the step of applying traction to the fastening device by at least one traction member. The at least one traction member may comprise a wire, a suture, a thread, a string or the like. A method for a surgical procedure may also comprise a step of inserting the fastening device by an introducer, such as a hollow device.
A related method for a surgical procedure comprises the steps of: a) Introducing a fastening device by an introducer into an abdomen cavity/a body organ/a natural orifice/a suitable space;
b) Opening the fastening device via the introducer;
c) Grabbing tissue, such as tissue of an internal organ;
d) Attaching the fastening device to the tissue;
e) Disconnecting the introducer from the fastening device;
f) Removing the introducer from the abdomen cavity/body organ/natural orifice/suitable space.
Another related method for a surgical procedure comprises the steps of: a) Introducing a fastening device into a body part;
b) Arranging a resilient locking member with the fastening device so that:
i) the fastening device grips a portion of tissue or the like, and ii) the fastening device grips at least one wire for attachment to the device;
c) Connecting the at least one wire, which is attached to the fastening device, with at least one suitable tool, such as a suture-grasping tool;
d) Disconnecting the introducer from the fastening device;
e) Removing the introducer from the body part;
f) Applying traction to the at least one wire so that traction is applied to the portion of tissue;
g) Removing the fastening device from the body part by a suitable tool. Another related method for a surgical procedure comprises the steps of: a) Introducing at least one wire to a body cavity.
b) Introducing at least one fastening device to the body cavity;
c) Opening the fastening device;
d) Connecting the at least one wire to the fastening device;
e) Grabbing tissue using the fastening device;
f) Arranging a resilient locking member with the fastening device for attaching the fastening device to the tissue and the at least one wire;
g) Optionally, repeating the steps a) - f) in order to introduce a plurality of wires and fastening devices.
h) Applying traction to the tissue by means of the at least one wire.
At least one of the methods above may comprise a step of introducing at least one wire from the outside of an abdominal cavity to the body cavity. At least one of the methods above may comprise a step of introducing the fastening device by an introducer, and may also comprise a step of opening the fastening device via an introducer. Further, at least one of the methods above may comprise a step of disconnecting the introducer from the fastening device and a step of removing the introducer and the fastening device from the body cavity. In addition, any of the above methods may also comprise a step of removing the fastening device with an organ or a portion of an organ, for instance a resected organ attached to the fastening device, along with the fastening device.
Further, at least one of the methods above may comprise a step of loading a fastening device into an introducer and inserting the introducer with the fastening device into a body part. Further, at least one of the methods above may comprise a step of passing at least one traction member through the wall of a body cavity. Traction may be applied from the outside and/or the inside of a body cavity. In relation hereto, at least one of the methods above may comprise a step of applying traction to a plurality of wires from outside the body cavity. At least one of the methods above may also comprise a step of applying traction to a plurality of wires attached to at least one fastening device.
Traction may for instance be applied to a plurality of wires from different directions. Further, there is provided a method for a surgical procedure using a device and/or a tool as described elsewhere in this document.
Brief description of the drawings
The invention is disclosed in more detail according to an embodiment wherein the fastening device constitutes a clip with reference to the accompanying drawings, in which:
FIG 1 .1 is a cross section side view of a clip in its open configuration consisting of two jaws distally, two middle-pieces and a flexible connecting piece proximally.
FIG 1 .2 is the same as FIG 1 .1 with the clip in its closed configuration.
FIG 1 .3 is the same as FIG 1 .2 in a perspective view.
FIG 2.1 is a cross section side view of an introducer, such as an entry tool,
carrying a clip in its closed configuration and a band for locking of the clip in a "ready-position".
FIG 2.2 is the same as FIG 2.1 but with the clip in its open configuration,
FIG 2.3 is the same as FIG 2.2 but with the clip in contact with tissue or an organ, FIG 2.4 is a cross section side view of the introducer and clip in a closed
configuration with tissue or an organ between the jaws of the clip and the band in a ready-position. is a cross section side view of the introducer and clip in a closed and locked configuration with tissue or an organ between the jaws of the clip and the band now around the clip keeping it in a locked configuration. is an enlarged detail of FIG 2.4.
is an enlarged detail of FIG 2.5.
is a cross section side view the introducer and clip in its locked configuration (due to the surrounding band) pushed forward to a release- position by a push-rod according to one embodiment of the present invention.
is a cross section side view of the introducer and the clip in its locked configuration with tissue or an organ between its jaws. The clip is released from the push-rod of the introducer. The sutures are pulled and being pulled trough the abdominal wall applying traction on the tissue by means of the sutures and the clip.
is a perspective view of the same as FIG 2.9.
is a cross section side view of the introducer carrying a clip in its closed configuration and a band for locking of the clip 6 in a "ready-position", according to one embodiment of the present invention, like FIG 2.1 , but with an extra suture between the clip and the tissue/organ introduced trough the abdominal wall.
is the same as FIG 3.1 but with the clip in its open configuration.
is the same as FIG 3.2 but with the clip in contact with tissue or an organ and the extra suture trapped behind two suture-catchers on the inside of the middle-pieces of the clip.
is a cross section side view of the introducer and clip in a closed configuration with tissue or an organ between the jaws of the clip, with the extra suture locked between the middle-pieces of the clip and the band in a ready-position.
is the same FIG 3.4 but with the locking-band around the clip keeping it in a locked configuration and keeping the extra suture locked between the middle-pieces of the clip.
is an enlarged view of a detail of FIG 3.4.
is an enlarged view of a detail of FIG 3.5.
is a cross section side view of the introducer and the clip with the entrapped extra suture in its locked configuration (due to the surrounding band) pushed forward to a release-position by a push-rod according to one embodiment of the present invention.
is the same as FIG 3.8 but with the clip released from the push-rod of the introducer and the sutures, including the extra suture, pulled and being pulled trough the abdominal wall applying traction on the tissue by means of the sutures and the clip,
is a perspective view of the same as FIG 3.9.
is a perspective view of an exit tool, such as a clip-remover and a clip in its locked configuration with tissue or an organ grasped between the jaws, is the same as FIG 4.1 but with a hook-shaped pin, a suture-catcher, introduced through a central channel in the exit tool to grasp the sutures at the proximal end of the clip.
is the same as FIG 4.2 but with the two sutures pulled trough the central channel of the exit tool.
is the same as FIG 4.3 but with the clip pulled into the exit tool between the jaws of a band grasper.
is a cross section side view of the same as FIG 4.4, showing a clip in its locked configuration with tissue or an organ grasped between the jaws, and an exit tool with the clip pulled in between the jaws of the exit tool, is the same as FIG 4.5 but the jaws of the clip-grasper has been locked to grasp the band around the clip.
is the same as FIG 4.6 but the clip is released from the locking-band when the band grasper is pulled back.
is a cross section side view of a clip with jaws specialized for grasping thin tissues.
is a cross section side view of a clip with jaws specialized for grasping fragile tissues.
is a cross section side view of a clip with jaws specialized for grasping thickened tissues.
is a cross section side view of a clip with jaws specialized for grasping organs with solid contents.
is a cross section side view of an alternative clip, representing an alternative mechanism for locking. The appearance of the clip is in its open configuration before it is inserted into an introducing instrument. FIG 6.2 is a cross section side view of the alternative clip in its "loaded" and closed configuration (not locked). This is the appearance of the clip when it is inserted into an introducing instrument and introduced into the abdominal cavity.
FIG 6.3 is a cross section side view of the alternative clip in its "loaded" and open configuration. This is the appearance when it has been introduced into the abdominal cavity and opened.
FIG 6.4 is a cross section side view of the alternative clip in its closed and locked.
This is the appearance when it has grasped an organ/tissue and is locked.
FIG 7.1 is a side view of a clip in an open configuration.
FIG 7.2 is a perspective view of a clip in a closed configuration.
FIG 7.3 is a perspective view of a clip in a partly configuration held by an tool. FIG 7.4 is a side view of a clip in an open configuration at the edge of the tube of a tool.
FIG 7.5 is a top view of the situation in fig. 7.4.
FIG 7.6 is a perspective of the proximal side of a clip showing the outer thread and the smooth upper surface.
FIG 8.1 is a perspective view of a tool with a clip totally enclosed by the tube. FIG 8.2 is a perspective view of a tool with a clip opening out of the tube.
FIG 8.3 is a perspective view of a tool with a clip partly enclosed by the tube. FIG 8.4 is a perspective view of a tool with a clip partly enclosed by the tube and engaged with the locking member
FIG 8.5 is a perspective view of a tool with a clip partly enclosed by the tube, engaged with the locking member and released from the tube by means of a guiding rod.
FIG 8.6 is a see-through side view of a tool with a clip totally enclosed by the tube.
FIG 9.1 is an illustration of another embodiment of the clip comprising an
attachment part.
Detailed description of the drawings
FIG 1 .1 According to one embodiment of the present invention a clip 1 is presented ' its open configuration. The figure shows a cross section side view of the clip 1 consisting of two arms that are connected via a proximal flexible portion C. The two arms have a middle-portion B and a distal portion A. The two distal portions are shaped with sharp edges pointing towards each other as teeth forming jaws. The middle- portions B have two j-shaped pins that almost touch 3. Shaped like that, together they form a "suture-catcher" as they work as a trap for a suture/thread/string/wire that will tend to stay on their concave inside. The two middle-portions are equipped with several side protrusions, such as convexities pointing outwards 5, shaped like this to create resistance (further explained in the following under FIG 1 .2). The proximal portion C has a ring-shaped central opening 4 suited for grasping or pulling or pushing the clip with another instrument or suture or needle. Attached to the proximal portion are two sutures/threads/strings/wires 2.
FIG 1 .2 is the same as FIG 1 .1 with the clip 1 in its closed configuration held together by a rigid band 6. This band 6 is placed around the middle-portion. It is equipped has several grooves, such as notches or concavities on its inside 7 which match the side protrusions on the middle-portion 5 of the clip 1 . The jaws almost touch. Each of the two J-shaped pins of the suture-catcher 3 fit into concavities on the opposite arms middle-portion, into which they bend and "disappear" (dotted lines). FIG 1 .3 is the same as FIG 1 .2 but in a perspective view showing the clip 1 kept in its locked configuration by the surrounding band 6, with a portion of tissue/organ 8 grasped between the jaws of the clip. Two sutures 2 are pulled upward creating traction on the tissue/organ via the clip. FIG 2.1 is a cross section side view of the introducer carrying a clip 1 and a band for locking of the clip 6. The clip-introducer consists of three tubes that fit into one another: an outer tube 9, a middle tube 10 and an inner tube 1 1 . The inner tube is in a fixed position, while the surrounding middle-tube and outer tube are mobile (can slide forward and back). In the inner tube is a rod 12a which is mobile as well. There is a short bend at the tip of the rod (like a hook) 12b. The bended tip 12b of the rod 12a fits into the ring-shaped hole 4 in the proximal flexible portion of the clip, thus keeping the clip inside the introducer. The clip is kept in a closed configuration by compression of the outer tube 9. A "locking-band" 6 is shaped to fit into the outer tube 9. The band that has the same outer diameter as the middle-tube, is positioned in front of the middle- tube, and is kept in place by a slight friction against the inner surface of the outer tube. In this position it is ready to be pushed around the middle portion of the clip in front of it (see below).
FIG 2.2 is the same as FIG 2.1 but with the clip 1 in its open configuration. This figure shows how the clip reverses to its open configuration when the outer tube 9 no longer presses the middle-portions of the clip together when the outer tube 9 is withdrawn (dotted arrows).
FIG 2.3 is the same as FIG 2.2 after the clip 1 has been advanced to be in contact with a portion of tissue or the surface of an organ 8.
FIG 2.4 is a cross section side view of the introducer 9, 10, 1 1 , 12a, 12b holding a clip 1 in its closed configuration with a portion of tissue/an organ 8 between the jaws and a locking-band 6 in a "ready-position". The figure illustrates how the jaws of the clip close (bended dotted arrows) and grasp a portion of tissue/organ 8 when the outer tube 9 slides forward (dotted arrow) and forces the arms of the clip together.
FIG 2.5 is a cross section side view of the introducer 9, 10, 1 1 , 12a, 12b and clip 1 in a closed and locked configuration with tissue/an organ 8 between the jaws of the clip and the band 6 around the clip keeping it in a locked configuration 6.
FIG 2.6 is an enlarged detail of FIG 2.4. It shows the "ready-position" of the locking- band within the outer-tube (kept in place by means of contact with the outer-tube) 9, in front of the middle-tube 10 and around (but not in contact with) the inner-tube 1 1 . Thus the band 6 is ready to be pushed forward to surround the clip in a locked position (see 2.7).
FIG 2.7 is an enlarged view of a detail of FIG 2.5 illustrating how the advancement of the middle-tube (dotted arrow) pushes the band forward till it surrounds the clip 1 . The further the band is pushed the tighter the jaws grasp the tissue/organ due to cone- shape of the clip and narrowing diameter of the hole in the band.
FIG 2.8 is a cross section side view the introducer 9, 10, 1 1 , 12, 12a, 12b and clip 1 in its locked configuration (due to the surrounding band). The figure shows the clip 1 pushed out of the outer-tube of the introducer by a rod 12a (dotted arrow) that holds the clip with the bended tip the rod 12b in the hole 4 of the proximal end of the clip.
FIG 2.9 is a cross section side view of the introducer 9, 10, 1 1 , 12a, 12b and the clip 1 in its locked configuration with tissue or an organ between its jaws. The clip is released from the rod 12a. The sutures 2 are pulled, and being pulled, trough the abdominal 14 wall by use of a special instrument 13, in the following referred to as a suture-grasper, thus applying traction on the tissue/organ 8 by means of the sutures 2 and the clip 1 . FIG 2.10 is a perspective view of the same as FIG 2.9. The sutures 2 are pulled at from the outside of the abdominal wall applying traction on the tissue/organ 8 by means of the sutures 2 and the clip 1 from two different directions.
The figures 3.1 -3.10 show how to attach at least one extra suture/thread/wire/line between the middle-portion of the clip-arms.
FIG 3.1 is a cross section side view demonstrating the abdominal wall 14 trough which at least one suture/thread/string/wire 15 is introduced though a cannula 16. The clip is placed in front of the suture. Like FIG 2.1 , the figure also shows a cross section side view of one embodiment of an introducer 9, 10, 1 1 and clip 1 and a locking-band 6 carried in the introducer (see detailed description of FIG 2.1 ).
FIG 3.2 is the same as FIG 3.1 but with the clip 1 in its open configuration and the suture passing through the abdominal wall after the cannula has been removed.
Furthermore, this figure shows how the clip reverses to its open configuration (bended dotted arrows) when the outer tube 9 is drawn backwards (dotted arrows) and no longer compresses the middle-portions of the clip together.
The figures 3.3-3.8 are identical to the figures 2.3-2.8 except for the illustration and description of the position of the extra suture/thread wire/line 15.
FIG 3.3 is the same as FIG 3.2 but with the clip 1 in contact with the tissue/organ 8 and the extra suture trapped behind the suture-catcher 3 between the middle-pieces of the clip. FIG 3.4 is a cross section side view of the introducer 9, 10, 1 1 , 12a, 12b holding a clip 1 in its closed configuration with a portion of tissue/an organ 8 between the jaws and the extra suture 15 in a fixed position between the middle-portion of the clip-arms behind the suture-trap 3. As in FIG 2.4 the figure also illustrates the position of the locking-band 6 and how the jaws of the clip close (bended dotted arrows) and grasp a portion of tissue/organ 8 when the outer tube 9 slides forward (dotted arrow) and forces the arms of the clip together.
FIG 3.5 is the same as FIG 3.4 but additionally illustration a changed position of the locking-band 6 around the clip keeping it in a locked configuration (see FIG 3.6 and 3.7 for further details).
FIG 3.6 is an enlarged detail of FIG 3.4. It shows the "ready-position" of the locking- band within the outer-tube (kept in place by means of a slight contact with the outer- tube) 9, in front of the middle-tube 10 and around (but not in contact with) the inner- tube 1 1 . Thus the band 6 is ready to be pushed forward to surround the clip in a locked position (FIG 3.7).
FIG 3.7 is an enlarged view of a detail of FIG 2.5 illustrating how the advancement of the middle-tube (dotted arrow) pushes the band forward till it surrounds the clip 1 . The further the band is pushed the tighter the jaws grasp the tissue/organ due to cone- shape of the clip and narrowing diameter of the hole in the band.
FIG 3.8 is a cross sectional side view the introducer 9, 10, 1 1 , 12a, 12b and clip 1 in its locked configuration (due to the surrounding band). The figure shows the clip 1 pushed out of the outer-tube of the introducer by a rod 12a (dotted arrow) that holds the clip with the bended tip the rod 12b in the hole 4 of the proximal end of the clip.
FIG 3.9 is a cross section side view of the introducer 9, 10, 1 1 , 12a, 12b and the clip 1 in its locked configuration with tissue or an organ between its jaws. The extra suture 15 is pulled at from the outside of the abdominal wall thus applying traction on the tissue/organ. The clip is released from the tip of the rod 12b. The sutures 2 are dragged out of the introducer along with the clip now ready to be pulled trough the abdominal 14 wall with a suture-grasper 13 as illustrated at FIG 2.9. FIG 3.10 is a perspective view of the same as FIG 3.9 but after both the extra suture 15 and the sutures attached to the proximal end of the clip 2 is pulled at from the outside of the abdominal wall. The figure illustrates how traction can be applied by means of at least three sutures in at least three different directions.
The figures 4.1 -4.7 illustrate how a clip can be unlocked and removed if necessary.
FIG 4.1 is a perspective view of a clip 1 in its locked configuration, locked by a surrounding locking-band 6. The clip grasp a portion of tissue/organ 8 between its jaws and two sutures 2 apply traction on the clip and tissue/organ by means of traction on the sutures 2. The sutures 2 are pulled at from the outside of the abdominal wall (see FIG 2.9 and 3.10).
FIG 4.2 is a perspective view of a clip 1 and an exit tool, such as a clip-remover consisting of a hook-shaped suture-grasper 17, a band-grasper 18 (in its closed configuration) and an outer-tube 19. The sutures 2 have been caught within the hook of the suture-grasper 17.
FIG 4.3 is a perspective view of a clip 1 and an exit tool 18, 19. The band-grasper 18 has changed to its open configuration by being pushed forward (dotted arrows). The clip 1 is being pulled into the exit tool by means of traction on the sutures 2 that have been pulled trough a central channel of the exit tool by means of the suture-grasper.
FIG 4.4 is the same as FIG 4.3 but with the clip 1 are pulled further into the exit tool, here the locking-band is surrounded by the tip of the band-grasper 18.
FIG 4.5 is the same as FIG 4.4 but in a cross section side view. It shows a clip 1 in its locked configuration, kept that way by a surrounding locking-band 6. Tissue or an organ 8 is grasped between the jaws of the clip. The exit tool is shown with an outer- tube 19 and the band-grasper 18 in its open configuration surrounding the proximal part of the clip. It is seen that the tip of the band-grasper is shaped to fit around the locking-band. An inner-tube (non-movable) 20 has a central channel through which the sutures 2 are pulled. FIG 4.6 is the same as FIG 4.5 but the band-grasper 18 has been locked to grasp the band 6 on the clip by sliding the outer-tube 19 forward (dotted arrows) thus forcing the band-grasper to close. FIG 4.7 is the same as FIG 4.6 but the clip is being released from the locking-band that stays trapped between the jaws of the band grasper, and removed when the band grasper 18 is pulled back (dotted arrow). The clip releases the tissue/organ and can be removed from the abdominal cavity with the exit tool. The jaw members of the clips may be provided to match the specific surgical application, e.g. to grab a gall bladder containing a gallstone it may be advantageously with concave jaw members, when grabbing a thick walled gall bladder it may be advantageously with jaw members with sharp teeth to provide a firm grip, and to grab a part of an intestine it may be advantageously to use jaw members with rounded teeth to protect the intestine. Fig. 5 shows different example of jaw members.
FIG 5.1 is a cross section side view a clip with jaws specialized for grasping thin tissues such as the wall of a gallbladder. FIG 5.2 is a cross section side view a clip with jaws specialized for grasping fragile tissues like the wall of intestine.
FIG 5.3 is a cross section side view a clip with jaws specialized for grasping thickened such as the wall of a gallbladder with inflammation.
FIG 5.4 is a cross section side view a clip with jaws specialized for grasping organs with solid contents like a stone in a gallbladder.
FIG 6.1 is a cross section side view of an alternative clip, representing an alternative mechanism for locking. This appearance of the clip is in its non-loaded open configuration before it is inserted into an introducing instrument. On one of the arms 3a, 3b of the clip there is a flexible slightly downwards pointing prong 21 that fit into an upper 24 and a lower 25 opening in the opposite arm. The prong is equipped with serrations 22 that are engageable with serrations 23 on the edge of the lower opening 25. At least two sutures are attached to the proximal end of the clip, ready to be used for applying traction as described in the detailed description of Fig. 2.9 and 2.10.
FIG 6.2 is a cross section side view of the alternative clip in its loaded and closed (but not locked) configuration. This is the appearance of the clip when it is inserted into an introducing instrument and introduced into the abdominal cavity. In this loaded configuration, the prong 21 is placed in the upper opening 24 in which it is lifted so the serrations 22 are not caught by the serrations on the lower opening 25. FIG 6.3 is a cross section side view of the alternative clip in its loaded and open configuration. This is the appearance when it has been introduced into the abdominal cavity and opened, ready to grasp an organ/tissue. When the clip opens, the flexible prong 21 falls out of the upper opening 24 into a position where it points into the lower opening 25.
FIG 6.4 is a cross section side view of the alternative clip in its closed and locked configuration. This is the appearance when the jaws 1 a of the clip has grasped an organ/tissue and is locked. When closed, the prong 21 it pushed into the lower opening 25. The serrations of the prong 22 is now stepwise engaged and locked by the fitting serrations 23 on the edge of the lower opening 25.
Figures 7 and 8 show another embodiment of the invention where the clip is rotatably engaged by the locking member and the position of the locking member relative to the jaw members are controlled by rotation of the locking member. The corresponding tool that facilitates steering and guiding of the clip and rotation of the locking member is thereby adapted to guide the clip during laparoscopic surgery e.g. inside the abdomen, fastening the clip to an organ by grabbing a portion of tissue, releasing the clip from the tissue and retracting the clip into the tube and out of the abdomen. Fig. 7.1 - 7.6 show different views and functionalities of a clip 71 according to one embodiment of the invention. The two jaw members 71 ', 71 " and the connecting portion 74 form a clamp. The connecting portion 74 is attached to the jaw members 71 ', 71 " in the proximal end thereof. By making the connecting portion 74 resilient the clip 71 can be made self-opening and the part of the connecting portion 74 that extends from the jaw members 71 ', 71 " can be shaped to provide a loop portion that may be grabbed by a hook shaped tool. This is illustrated e.g. in figs. 7.2 and 8.5 where the hook shaped end portion 82b of a guiding rod 82a holds the clip 71 via the connecting portion 74. The clip 71 is provided with an outer thread 75 which extends only partly around the circumference of the jaw members 71 71 " leaving a part of the outer surface as a substantially smooth surface 75'. In figs. 7.3, 7.4 and 7.5 the clip 71 is illustrated in connection with a corresponding tool. When the clip 71 exits and enters the tube 79 of the tool the outer surface 75' glides against the inner surface edge of the tube 79, especially if the clip is self-opening. If the outer thread 75 extended all the way round the clip 71 the thread 75 may prevent the clip 71 from entering or exiting the tube. The smooth surface 75' ensure a smooth transition between the clip 71 and the tube 79.
As seen from figures 7.2 and 7.3 the inner distal gripping surface 73 of the clip 71 is provided with indentations to provide a firm grip of the tissue portion. Further, the gripping surface 73 of clip 71 is made as large as possible to distribute the pinching force of the clip 71 over the largest possible area to protect the tissue portion. But as described in connection with figs. 5.1 - 5.4 the jaws of the clip may take many forms and shapes that may be adapted to the specific application.
The locking member 76 is provided with an inner thread that matches the outer thread 75 of the clip 71 . The locking member is illustrated as partly transparent in figs. 7.1 and 7.3 to illustrate the inner thread. The locking member is provided with a protruding portion 76' that functions as the engagement portion that matches a corresponding engagement portion 80' of a driving member 80 of the tool.
The clip is tapered towards the proximal end, i.e. the cross-sectional area of the clip (in a closed configuration) is minimal at the proximal end and increases toward the distal end. The cross-sectional area of the distal end of the clip 71 substantially matches the cross-sectional area of the tube 79 (as seen in fig. 8.1 and 8.6). The tapered proximal end of the clip 71 enables an easier engagement with the locking member 76 if the locking member is engaged when the clip is in a partly open configuration. By subsequent rotation the locking member 76 will travel along the outer side of the clip when the threads of the clip 71 and the locking member engage each other. The tapered form of the clip enables a gradual closing of the clip 71 as the locking member 76 travels from the proximal end of the clip towards the distal end of the clip. This is illustrated in figs. 7.1 , 7.2 and 7.3: In fig. 7.1 the locking member 76 is about to engage the proximal end of the clip 71 . In fig. 7.3 the locking member 76 is approx. halfway through the thread 75 and the clip 71 is now partly closed. In fig. 7.3 the clip is closed because the locking member 76 is engaged all through the thread 75. Thus, the position of the locking member 76 relative to the jaw members 71 ', 71 " determines the enveloping force of the locking member, i.e. the pinching effect of the clip 71 . The rotatable engagement between the jaw members and the locking member 76 provides for both stepwise and continuous adjustment of the enveloping force / pinching effect.
Fig. 8.1 - 8.6 show different views and functionalities of a tool according to one embodiment of the invention. The tool is also partly visible in figs. 7.3, 7.4 and 7.5. In fig. 8.1 . the clip 71 is totally enclosed by the tool and only visible from the end. The tool is provided with an outer tube 79 attached to a handle 81 and with a driving member 80 and a guiding rod 82a concentrically arranged inside the tube 79 and extending trough the handle 81 . Thus, the driving member 80 and the guiding rod 82a are controllable from the handle, i.e. outside of the abdomen during surgery. The guiding rod 82a and the driving member 80 are slidably movable inside the tube and the guiding rod 82a is slidably movable inside the driving member 80. The guiding rod 82a can be attached to the clip 71 via the hook shaped handle 82b. Thus, the clip 71 can be guided back and forth inside the tube via the guiding rod 82a. The guiding rod 82a also enables that the clip can be extended from the tube. With a self-opening clip 71 the clip will start opening when extended from the tube 79 when the clip is not engaged by locking member 76. This is illustrated in fig. 8.2. If the clip 71 is retracted back into the tube 79 by means of the guiding rod 82a the clip will close as the outer surface of the clip slides along the inner edge of the tube. Thus, one way of opening and closing the clip 71 is by pushing it out the tube 79 and pulling it into the tube 79 again. As seen from fig. 8.2 the clip may open in a large "bite". With a self-opening clip the clip 71 will typically open 45- 60 degrees. However, this may be adapted to suit the situation and the application of the clip.
Thus, to grab a portion of tissue the clip 71 can be pushed out of the tube 79 (fig. 8.2), the tube (and thereby the open clip) can be guided towards the tissue portion and by subsequently guiding the tube 79 (fig. 8.3) over the clip by means of the guiding rod 82a, the jaw member are forced together by the tube opening and the tissue portion is thereby grabbed ad retained. Subsequently the locking member 76 may be engaged with the jaw members of the clip 71 . The position of the locking member 76 inside the tube 79 is controlled by slidably moving the driving member 80, thus the locking member may be guided towards the proximal end of the jaw members. The locking member may then be rotated by rotating the driving member by means of rotating the wheel 80a. The threads of the jaw members and the locking member now engage and by rotating the driving member 80 the locking member 76 travels along the outside of the jaw members thereby forcing the jaw members closer together (fig. 8.4). The pinching force of the clip 71 is thereby adjusted.
The clip 71 now has a firm grip of the tissue portion (the tissue portion is not shown in figs. 7 and 8). The clip 71 can subsequently be pushed out of the tube 79 by means of the guiding rod 82a (fig. 8.5). The locking member 76 is now engaged with the jaw members ensuring a firm grip of the tissue portion. The clip 71 can subsequently be released from the guiding rod 82a by unhooking the end portion 82b. The clip is thereby fastened to a tissue portion and released from the tool.
The loose clip 71 can be caught again by the hook shaped end portion 82b. The guiding rod 82a is rotatable inside the driving whereby the hook portion 82b can be rotated to adapt to the loop portion 74 of the clip 71 . The clip 71 is then retracted into the tube 79 where the driving member can engage the locking member and unscrew the locking member. Pushing the clip 71 out of the tube 79 will then open the clip 71 and the tissue portion is released. The clip can subsequently be retracted back into the tube 79 and the tool containing the clip can be retracted from the abdomen.
As seen from the figures the handle 81 is provided with a space defined between edges 81 a, 81 b wherein the control wheel 80a of the driving member can move.
Fig. 9.1 shows an embodiment of the clip where the locking member engages the clip by means of an attachment part 85 extending from the proximal end of the jaw members. In this example the locking member 76 (which is cut through in the illustration to be able to see the underlying attachment part 85) and the attachment part comprises matching threads such that they can engage with each other. For the locking member 76 to engage with the jaw members it must first be translated along the attachment part 85 by rotating the locking member 76 relative to the attachment part 85 by means of the driving member 80. The attachment part is attached to the jaw members and the end portion 82b of the guiding rod grabs the attachment part 85.
The clip according to the invention is typically provided as a way of anchoring a suture to an organ. Thus, typically some kind of traction member, such as a suture, will be attached to the clip 71 . Typically the traction member will be attached to the distal end of the clip 71 and extend through the tool. This traction member is not illustrated in figs. 7, 8 and 9 but the functionality and application of traction members is described in connection with figures 1 -6.
While specific and preferred embodiments of the invention have been shown and described in detail above to illustrate the inventive principles, it is realised that variants to these embodiments may be provided without departing from the scope of the invention as set forth in the accompanying claims. The clip may for instance comprise more than two jaw members, such as three jaw members or even more jaw members and more than one locking member may be arranged with the jaw members.

Claims

Claims
1 . A clip for gripping a portion of tissue comprising at least a first and a second jaw member connected to each other at proximal ends thereof, and a locking member adapted bring the jaw members closer together when said locking member is engaged with the proximal ends of the jaw members by a suitable tool,
the clip characterized in that
the enveloping force exerted by the locking member is adjustable depending on the position of the locking member relative to the jaw members.
2. The clip according to claim 1 , wherein the clip is self-opening.
3. The clip according to any of claims 1 or 2, wherein the locking member is
resilient.
4. The clip according to claim 3, wherein the locking member is adapted to be expanded in diameter and thereby adapted to exert forces towards the jaw members such that the jaw members are brought together as said resilient locking member is envelopingly arranged with the at least first and second jaw members.
5. The clip according to any of the preceding claims, wherein the locking member is envelopingly engaged with the jaw members.
6. The clip according to any of the preceding claims, wherein the first jaw member comprises a first distal portion and a first proximal portion so that a first axis passes through the first distal portion and the first proximal portion, whereby a first direction along the first axis is directed in the direction from the first proximal portion to the first distal portion, and
wherein the second jaw member comprises a second distal portion and a second proximal portion so that a second axis passes through the second distal portion and the second proximal portion, whereby a second direction along the second axis is directed in the direction from the second proximal portion to the second distal portion, and whereby a third axis is lying between the first axis and the second axis so that a third direction along the third axis is directed in a direction lying between the first and second directions.
7. The clip according to any of the preceding claims, wherein said first and second jaw members are connected by means of a connecting portion.
8. The clip according to claim 7, wherein the connecting portion is resilient.
9. The clip according to any of claims 7 to 8, wherein the connecting portion
comprises a tension spring member.
10. The clip according to any of the preceding claims, further comprising an
attachment part extending from the proximal end of the jaw members.
1 1 . The clip according to claim 10, wherein said locking member is adapted to
engage with the attachment part.
12. The clip according to any of claims 10 to 1 1 , wherein said locking member is engaged with the attachment by means of fastening means.
13. The clip according to any of claims 10 to 12, wherein said locking member is adapted for rotatable engagement with the attachment part.
14. The clip according to any of claims 10 to 13, wherein the locking member and the attachment part are provided with matching threads for rotatable
engagement of the locking member with the attachment part.
15. The clip according to any of the preceding claims, wherein said locking member is adapted to at least partially envelop matching portions of the first and second jaw members.
16. The clip according to any of the preceding claims, wherein the locking member is adapted for retaining a plurality of positions relative to the jaw members.
17. The clip according to any of the preceding claims, wherein the locking member and the jaw members are adapted for stepwise engagement with each other, whereby the locking member may retain a plurality of positions relative to the jaw members.
18. The clip according to any of the preceding claims, wherein the position of the locking member relative to the jaw members is stepwise adjustable.
19. The clip according to any of the preceding claims, wherein the position of the locking member relative to the jaw members is continuously adjustable.
20. The clip according to any of the preceding claims, wherein the position of the locking member relative to the jaw members is adjusted by rotating the locking member.
21 . The clip according to any of the preceding claims, wherein said locking member is adapted for rotatable engagement with the jaw members.
22. The clip according to any of the preceding claims, wherein said locking member is engaged to the jaw members by means of fastening means.
23. The clip according to any of the preceding claims, wherein the outer surfaces of the proximal end of the jaw members comprise protrusions and/or grooves, preferably extending in a substantially cross-sectional direction.
24. The clip according to any of the preceding claims, wherein the locking member and the jaw members are provided with matching threads for rotatable engagement of the locking member with the jaw locking members.
25. The clip according to claim 24, wherein the threads provided on the jaw
members extend only partially around the circumference of the proximal ends of the jaw members.
26. The clip according to any of claims 24 to 25, wherein at least a part of the outer surfaces of the proximal ends of the jaw members are smooth.
27. The clip according to any of claims 24 to 26, wherein the diameter of the thread provided inside the locking member is gradually increasing.
28. The clip according to any of the preceding claims, wherein the first and second jaw members have a form so that the resilient locking member is adapted to exert forces towards the jaw members
29. The clip according to any of the preceding claims, wherein the cross sectional area of the first and second jaw members is varying.
30. The clip according to any of the preceding claims, wherein the cross-sectional area of the jaw members is gradually increasing from the proximal end towards the distal end of said jaw members.
31 . The clip according to any of the preceding claims, wherein the jaw members are tapered towards the proximal end.
32. The clip according to any of the preceding claims, wherein the first and second jaw members are adapted for pivotally engagement.
33. The clip according to any of the preceding claims, wherein the locking member comprises a tension spring member.
34. The clip according to any of the preceding claims, wherein the locking member is adapted to be engaged by a matching driving member of a suitable tool.
35. The clip according to any of the preceding claims, wherein the locking member comprises an engagement portion adapted for matching a corresponding engagement portion of a driving member of a suitable tool.
36. The clip according to claim 35, wherein the engagement portions comprise one or more protrusions, notches and/or grooves.
37. The clip according to any of the preceding claims, wherein the locking member is adapted for stepwise engagement with the matching portion of the first jaw member and/or the matching portion of the second jaw so that a number of closed configurations are provided.
38. The clip according to any of the preceding claims, wherein at least the matching portion of the first jaw member and/or the matching portion of the second jaw member comprise/comprises side protrusions and/or grooves.
39. The clip according to any of the preceding claims, further comprising a grasping portion adapted for being grasped by a suitable tool.
40. The clip according to claim 39, wherein the grasping portion is adapted for being grasped by a hook shaped tool.
41 . The clip according to any of claims 39 to 40, wherein the grasping portion is part of the connecting portion.
42. A clip for gripping a portion of tissue, comprising at least a first jaw member having a first distal portion and a first proximal portion so that a first axis passes through the first distal portion and the first proximal portion, whereby a first direction along the first axis is directed in the direction from the first proximal portion to the first distal portion, at least a second jaw member having a second distal portion and a second proximal portion so that a second axis passes through the second distal portion and the second proximal portion, whereby a second direction along the second axis is directed in the direction from the second proximal portion to the second distal portion, and whereby a third axis is lying between the first axis and the second axis so that a third direction along the third axis is directed in a direction lying between the first and second directions, a connecting portion, and said at least first and second jaw members being connected through the connecting portion, wherein a resilient elongated projecting locking body protrudes from the first jaw member in a direction substantially perpendicular to the first axis, said elongated projecting locking body being adapted for engagement with a matching first opening of the at least second jaw member, and said elongated projecting locking body and/or said matching first opening comprising a locking means so that the elongated projecting locking body is adapted to exert forces to the jaw members such that the jaw members are brought together as said elongated projecting locking body is received by the matching first opening.
43. The clip according to claim 42, wherein the locking means comprises
protrusions and/or grooves, such as notches, arranged with the elongated projecting locking body and/or the matching first opening.
44. The clip according to any of the claims 42 or 43, wherein the at least second jaw member comprises a supporting second opening adapted for housing the elongated projecting locking body.
45. The clip according to any of the preceding claims, comprising at least one
attachment means for attaching at least one traction member.
46. The clip according to any of the preceding claims, wherein the first and/or
second jaw member comprise/comprises at least one traction member receiving portion adapted for receiving and securing at least one traction member.
47. The clip according to claim 46, wherein the fastening device is adapted so that the traction member receiving portion(s) may receive and secure at least one traction member at the same time as the fastening device is secured to a tissue portion or the like.
48. The clip according to any of the claims 46 or 47, wherein the fastening device comprises at least one means for guiding and/or catching a traction member in cooperation with the receiving portion(s).
49. The clip according to any of the preceding claims comprising an active opening mechanism and/or an active closing mechanism.
50. The clip according to any of the preceding claims, wherein the clip is
disposable.
51 . The clip according to any of the preceding claims, wherein the clip is made for repeated use.
52. A tool adapted for the clip according to any of the preceding claims, said tool comprising a driving member adapted for engagement with the locking member of the clip such that the locking member can be engaged with the proximal ends of the jaw members of the clip by means of the driving member.
53. The tool according to claim 52, wherein the driving member is adapted to adjust the position of the locking member relative to the jaw members.
54. The tool according to claim 53, wherein the position of the locking member is adjusted by rotation of the driving member.
55. The tool according to any of claims 52 to 54, wherein the driving member is adapted to arrange the locking member in a plurality of positions relative to the jaw members.
56. The tool according to any of claims 52 to 55, wherein the driving member
comprises an engagement portion adapted to match an engagement portion of the locking member.
57. The tool according to any of claims 52 to 56, further comprising a tube attached to a handle and a guiding rod for guiding the clip, wherein the tube at least partly encloses the driving member and the guiding rod, and wherein the driving member and the guiding rod are operable / controllable from the handle.
58. The tool according to claim 57, wherein the guiding rod and the driving member are arranged concentrically in the tube.
59. The tool according to any of claims 57 to 58, wherein the guiding rod comprises grasping means for gripping the clip.
60. The tool according to any of claims 57 to 59, wherein the guiding rod and the driving member are arranged to be movable independently.
61 . The tool according to any of claims 57 to 60, wherein the opening of the tube substantially matches the cross-sectional area of the jaw members in the closed configuration.
62. The tool according to any of claims 57 to 61 , wherein the guiding rod and/or the driving member are arranged to be slidably movable and/or rotatable inside the tube.
63. The tool according to any of claims 57 to 62, wherein the guiding rod is
arranged to be slidably movable and/or rotatable inside the driving member.
64. The tool according to any of claims 57 to 63, wherein the guiding rod and the tube are arranged such that pulling the self-opening clip into the tube by means of the guiding rod brings the jaw members closer together.
65. The tool according to any of claims 52 to 64, wherein the tool is adapted for guiding, delivering, fastening, loosening and retracting the clip.
66. The tool according to any of claims 52 to 65 specifically adapted for guiding and/or delivering and/or fastening the clip, wherein the locking member is resilient and can be arranged envelopingly with at least first and second jaw members of the fastening device by means of the driving member.
67. The tool according to claim 66, wherein the resilient locking member is
arranged envelopingly with the at least first and second jaw members as the driving member is moved in the third direction, such as moved towards the distal portions of the jaw members.
68. The tool according to any of the claims 66 to 67, wherein the driving member comprises a first engagement portion, and said first engagement portion being adapted for engagement with a matching second driving engagement portion of a resilient locking member which is adapted to be arranged envelopingly with the fastening device.
69. The tool according to claim 68, wherein the first engagement portion comprises a surface which is directed substantially in the third direction as the resilient locking member is arranged envelopingly with jaw members of the fastening device by means of at least the driving member.
70. The tool according to any of the claims 68 or 69, wherein the first engagement portion has the shape of an annulus.
71 . The tool according to any of the claims 66 to 70, comprising at least one
support member for supporting the fastening device while the resilient locking member is arranged with the at least first and second jaw members.
72. The tool according to any of the claims 66 to 71 , wherein the tool comprises a housing adapted for housing at least a portion of the driving member and/or at least one resilient locking member and/or at least a portion of the fastening device.
73. The tool according to any of the claims 66 to 72, wherein the tool comprises a guiding rod adapted for guiding the fastening device.
74. The tool according to claim 73, wherein the guiding rod is elongated and has a bend in its distal end, said bend having an angle of approximately 90 degrees.
75. The tool according to any of the claims 73 or 74, wherein the guiding rod has an engagement portion adapted for engagement with a matching engagement portion of the fastening device.
76. The tool according to any of the claims 72 to 75, wherein the housing is adapted to eject at least one fastening device.
77. A tool specifically adapted for changing the configuration of a resilient locking member which is envelopingly arranged with a fastening device according to any of the claims 1 to 51 .
78. The tool according to claim 77, comprising at least one grasping member, said at least one grasping member having at least one first engagement portion which is adapted for engagement with a matching second grasping engagement portion of a resilient locking member, and said resilient locking member being adapted to be arranged envelopingly with the jaw members of the fastening device.
79. The tool according to claim 78, wherein the at least one first engagement portion comprises at least one first surface which is directed in a direction opposite the third direction.
80. The tool according to claim 79, wherein the at least one first surface is at least partly shaped as an annulus.
81 . The tool according to any of the claims 78 to 80, wherein the first engagement portion is adapted for engagement with a matching grasping engagement portion of a resilient locking member, which is arranged envelopingly with jaw members of the fastening device, such that the resilient locking member is adapted to be moved, by means of the at least one grasping member, in a direction opposite the third direction.
82. The tool according to any of the claims 78 to 81 , wherein the at least one grasping member is capable of enveloping a resilient locking member which is arranged envelopingly with jaw members of the fastening device.
83. The tool according to any of the claims 78 to 82, wherein the at least one grasping member comprises at least a first cylinder portion and at least a second cylinder portion.
84. The tool according to any of the claims 78 to 83, wherein the at least one
grasping member comprises a plurality of hollow cylinder sections.
85. The tool according to any of the claims 78 to 84, wherein the at least one
grasping member is adapted to extend from the inside of a support housing.
86. The tool according to claim 85, wherein the at least one grasping member is adapted to be slideably moved at least partly into and/or out of the support housing.
87. The tool according to any of the claims 78 to 86, wherein the at least one
grasping member comprises at least one first portion which is adapted to expand in radial directions when the at least one grasping member is moved out of the support housing.
88. The tool according to claim 87, wherein the at least one first portion has an engagement portion for engagement with a support member so that the support member is adapted to move the at least one first portion in directions opposite radial directions, as the support member is moved substantially in the third direction and/or as the at least one grasping member is moved substantially in an opposite direction.
89. The tool according to any of the claims 87 or 88, wherein the at least one first portion is adapted to be slideably moved into and/or out of the support member.
90. The tool according to any of the claims 87 to 89, wherein the at least one first portion comprises a stopping means adapted for engagement with the support member so that the at least one grasping member is prevented from being fully enclosed by the support member.
91 . The tool according to claim 90, wherein the stopping means comprises at least one surface portion directed substantially in the opposite direction of the third direction.
92. The tool according to claim 91 , wherein the at least one surface portion is at least partly shaped as an annulus.
93. The tool according to any of the claims 91 or 92, wherein the surface portion is adapted for engagement with a matching engagement portion of the support member.
94. A method for gripping a portion of tissue comprising the steps of: a) Inserting a fastening device into a body part;
b) Arranging a resilient locking member with the fastening device so that the fastening device grips a portion of tissue or the like;
95. The method according to claim 94, further comprising the step of applying traction to the fastening device by at least one traction member.
96. The method according to any of the claims 94 to 95 comprising a step of inserting the fastening device by an introducer, such as a hollow device.
97. The method according to any of the claims 94 to 96 comprising the steps of: a) Introducing a fastening device by an introducer into an abdomen cavity/a body organ/a natural orifice/a suitable space;
b) Opening the fastening device via the introducer;
c) Grabbing tissue, such as tissue of an internal organ;
d) Attaching the fastening device to the tissue;
e) Disconnecting the introducer from the fastening device;
f) Removing the introducer from the abdomen cavity/body organ/natural orifice/suitable space.
98. The method according to any of the claims 94 to 97 comprising the steps of: a) Introducing a fastening device into a body part; b) Arranging a resilient locking member with the fastening device so that:
i) the fastening device grips a portion of tissue or the like, and
ii) the fastening device grips at least one wire for attachment to the device;
c) Connecting the at least one wire, which is attached to the fastening device, with at least one suiteable tool, such as a suture-grasping tool;
d) Disconnecting the introducer from the fastening device;
e) Removing the introducer from the body part;
f) Applying traction to the at least one wire so that traction is applied to the portion of tissue;
g) Removing the fastening device from the body part by a suiteable tool.
99. The method according to any of the claims 94 to 98 comprising the steps of: a) Introducing at least one wire to a body cavity.
b) Introducing at least one fastening device to the body cavity;
c) Opening the fastening device;
d) Connecting the at least one wire to the fastening device;
e) Grabbing tissue using the fastening device;
f) Arranging a resilient locking member with the fastening device for attaching the fastening device to the tissue and the at least one wire;
g) Optionally, repeating the steps a) - f) in order to introduce a plurality of wires and fastening devices.
h) Applying traction to the tissue by means of the at least one wire.
100. The method according to any of the claims 94 to 99 comprising a step of introducing at least one wire from the outside of an abdominal cavity to the body cavity.
101 . The method according to any of the claims 94 to 100 comprising a step of introducing the fastening device by an introducer.
102. The method according to any of the claims 94 to 101 comprising a step of opening the fastening device via an introducer.
103. The method according to any of the claims 94 to 102 comprising a step of disconnecting the introducer from the fastening device.
104. The method according to any of the claims 94 to 103 comprising a step of removing the introducer and the fastening device from the body cavity.
105. The method according to any of the claims 94 to 104 comprising a step of removing the fastening device with an organ or a portion of an organ, for instance a resected organ attached to the fastening device, along with the fastening device.
106. The method according to any of the claims 94 to 105 comprising a step of loading a fastening device into an introducer and inserting the introducer with the fastening device into a body part.
107. The method according to any of the claims 94 to 106 comprising a step of passing at least one traction member through the wall of a body cavity.
108. The method according to claim 107, wherein traction is applied from the outside and/or the inside of a body cavity.
109. The method according to any of the claims 107 or 108, comprising a step of applying traction to a plurality of wires attached to at least one fastening device.
1 10. The method according to any of claims 94 to 109 using a clip according to any of claims 1 to 51 and/or a tool according to any of claims 52 to 93.
PCT/DK2012/050084 2011-03-22 2012-03-21 Fastening device, related tools and methods WO2012126477A1 (en)

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DKPA201170134 2011-03-22

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CN113648019A (en) * 2021-09-02 2021-11-16 常州威克医疗器械有限公司 Clip applier and binding clip subassembly thereof
CN117717383A (en) * 2024-02-07 2024-03-19 哈尔滨医科大学 Single-end suturing device of transnasal endoscope

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CN113648019B (en) * 2021-09-02 2022-08-05 常州威克医疗器械有限公司 Clip applier and binding clip subassembly thereof
CN113648019A (en) * 2021-09-02 2021-11-16 常州威克医疗器械有限公司 Clip applier and binding clip subassembly thereof
CN117717383A (en) * 2024-02-07 2024-03-19 哈尔滨医科大学 Single-end suturing device of transnasal endoscope
CN117717383B (en) * 2024-02-07 2024-04-16 哈尔滨医科大学 Single-end suturing device of transnasal endoscope

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