CA2435870A1 - Through the scope endoscopic hemostatic clipping device - Google Patents

Through the scope endoscopic hemostatic clipping device Download PDF

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Publication number
CA2435870A1
CA2435870A1 CA002435870A CA2435870A CA2435870A1 CA 2435870 A1 CA2435870 A1 CA 2435870A1 CA 002435870 A CA002435870 A CA 002435870A CA 2435870 A CA2435870 A CA 2435870A CA 2435870 A1 CA2435870 A1 CA 2435870A1
Authority
CA
Canada
Prior art keywords
clip
control wire
medical device
lock
legs
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002435870A
Other languages
French (fr)
Other versions
CA2435870C (en
Inventor
Mark L. Adams
Russell F. Durgin
Vincent Turturro
Justin Grant
Norman May
Roy H. Sullivan, Iii
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd Barbados
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Individual
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Filing date
Publication date
Family has litigation
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Application filed by Individual filed Critical Individual
Publication of CA2435870A1 publication Critical patent/CA2435870A1/en
Application granted granted Critical
Publication of CA2435870C publication Critical patent/CA2435870C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128—Surgical 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
    • A61B17/1285—Surgical 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/083—Clips, e.g. resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227—Spring clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/0034—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means adapted to be inserted through a working channel of an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904—Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3916—Bone tissue

Abstract

Medical device used to cause hemostasis of blood vessels using a clip arrangement delivered to a target region through an endoscope. Method for using the device to cause hemostasis of a blood vessel through an endoscope.
Medical device including a reversibly closeable clip, a locking arrangement, a control wire, a sheath, and a handle with an actuating trigger. Through the endoscope, hemostatic clipping device that is fully reversible and lockable.
Hemostatic clip that reversibly targets and clips bleeding ulcers.

Claims (45)

1. A medical device for causing the hemostasis of a blood vessel for use through an endoscope, said medical device comprising:

a clip, the clip having at least two clip legs;

a control wire able to be coupled to the clip, the control wire reversibly operable both to open the at least two clip legs and to close the at least two clip legs, the control wire uncouplable from the clip;

an axially rigid sheath enclosing the control wire, the sheath able to communicate a first force opposing a second force of the control wire;

a handle coupled to the axially rigid sheath; and an actuator coupled to the control wire, the control wire engageable by the actuator to open the at least two clip legs, to close the at least two clip legs, and to uncouple the control wire from the clip.
2. The medical device of claim 1, wherein:
the actuator comprises a lever; and the lever able to transmit a fraction of an amount of an operator's movement of the lever into linear movement of the control wire, the fraction being less than one.
3. The medical device of claim 1, wherein:

the control wire is able to be coupled to the clip by a j-hook;

the j-hook is able to be straightened by a first predetermined tensile force; and when the j-hook is straightened, the control wire uncouples from the clip.
4. The medical device of claim 1, wherein:

the control wire is able to be coupled to the clip by a breakable link;

the breakable link is able to be broken by a first predetermined tensile force; and when the breakable link is broken, the control wire uncouples from the clip.
5. The medical device of claim 1, wherein:

the control wire is able to be coupled to the clip by a male thread coupled to a female hub;

the male thread and the female hub are able to be stripped apart by a first predetermined tensile force; and when the male thread and the female hub are stripped apart, the control wire uncouples from the clip.
6. The medical device of claim 1, wherein:
the control wire is able to be coupled to the clip by at least one ball on the control wire being situated within at least one socket on the clip;

the at least one ball on the control wire removable from the at least one socket; and when the ball is removed from the socket, the control wire uncouples from the clip.
7. The medical device of claim 6, wherein:

the socket is formed by at least two tabs;

each of the at least two tabs deformable by the ball into a corresponding cut-out in an outer sleeve at a predetermined tensile force; and when the at least two tabs are deformed, the control wire uncouples from the clip.
8. The medical device of claim 1, wherein:

the control wire is able to be coupled to the clip by at least one u-ring attached to the control wire situated around a constriction in the clip;

the at least one u-ring removable from around the constriction; and when the u-ring is removed from around the constriction, the control wire uncouples from the clip.
9. The medical device of claim 8, wherein:
the control wire comprises a shape memory material at least on a distal portion of the control wire; and when the control wire relaxes, the at least one u-ring moves away from around the constriction, and the control wire uncouples from the clip.
10. The medical device of claim 1, wherein:
the control wire is able to be coupled to the clip by at least one pill on the control wire being situated within at least one pill well on the clip;

the at least one pill removable from the at least one pill well; and when the pill is removed from the pill well, the control wire uncouples from the clip.
11. The medical device of claim 10, wherein:

the control wire comprises a shape memory material at least on a distal portion of the control wire; and when the control wire relaxes, the at least one pill moves out of the at least one well, and the control wire uncouples from the clip.
12. The medical device of claim 1, wherein:

the clip comprises at least one pin;
the control wire is able to be coupled to the clip by being threaded around the at least one pin; and when the control wire unthreads from around the at least one pin, the control wire uncouples from the clip.
13. The medical device of claim 1, wherein the control wire is able to couple to the clip by an elastic band.
14. The medical device of claim 13, wherein breaking the elastic band is able to uncouple the control wire from the clip.
15. The medical device of claim 13, wherein:
the control wire comprises a hook;

the hook is able to engage the elastic band; and the control wire is movable distally to unhook and disengage the control wire from the elastic band, thereby uncoupling the control wire from the clip.
16. The medical device of claim 1, further comprising a lock sleeve, wherein the control wire is able to be pulled in a proximal direction to pull the clip through the lock sleeve, thereby closing the clip legs.
17. The medical device of claim 16, wherein the control wire is able to be pushed in a distal direction to push the clip out of the lock sleeve, thereby opening the clip legs.
18. The medical device of claim 1, further comprising a lock sleeve, wherein the outer sleeve is able to be pushed in a distal direction to push the lock sleeve over the clip, thereby closing the clip legs.
19. The medical device of claim 18, wherein the outer sleeve is able to be pulled in a proximal direction to pull the lock sleeve away from around the chip, thereby opening the clip legs.
20. The medical device of claim 16 further comprising:
a retainer, the retainer releasably coupled to the lock sleeve; and a retainer release arrangement, the retainer release arrangement able to engage the retainer to uncouple the retainer from the lock sleeve.
21. The medical device of claim 1, further comprising a lock arrangement for locking the at least two clip legs in a closed position.
22. The medical device of claim 21, wherein the lock arrangement comprises:

at least two lock holes, the number of lock holes corresponding to the number of clip legs, each of the at least two lock holes situated on a corresponding clip leg;

a lock sleeve; and at least two lock pawls, the number of lock pawls corresponding to the number of clip legs, each of the at least two lock pawls situated on the lock sleeve;

wherein the at least two lock holes are engageable by the at least two lock pawls.
23. The medical device of claim 21, wherein the lock arrangement locking the at least two clip legs in a closed position comprises:

a rigid tube;

a coiled spring, the coiled spring arranged on the rigid tube, the rigid tube supporting the coiled spring in an expanded position, the coiled spring encircling the rigid tube on a distal end; and a coil engaging arrangement arranged on the clip legs;

wherein the rigid tube is engageable by the control wire, the rigid tube movable proximally with respect to the sheath, the coiled spring engageable by the sheath to cause the coiled spring to slide off the rigid tube onto the clip legs, thereby causing the coiled spring to engage the coil engaging arrangement on the clip legs to lock the clip legs in a closed position.
24. The medical device of claim 21, wherein the lock arrangement locking the at least two clip legs in a closed position comprises:

at least one pill situated on a distal end of the control wire; and at least one lock hole, wherein the control wire passes through at least one lock hole;

wherein the at least one pill is movable by the control wire proximally through the at least one lock hole; and wherein once the at least one pill moves proximally through the at least one lock hole, the at least one pill is not movable distally through the at least one lock hole.
25. The medical device of claim 21, wherein the lock arrangement locking the at least two clip legs in a closed position comprises:

a lock sleeve, the lock sleeve situated radially outward from the at least two clip legs; and at least two dimples, the number of dimples corresponding to the number of clip legs, each of the dimples situated on a corresponding clip leg;
wherein the at least two dimples are engageable by the lock sleeve.
26. The medical device of claim 21, wherein the lock arrangement locking the at least two clip legs in a closed position comprises:
at least two deformable lock tabs, the number of deformable lock tabs corresponding to the number of clip legs, each of the at least two deformable lock tabs situated on a proximal end of a corresponding clip leg; and at least two lock holes, the number of lock holes corresponding to the number of clip legs, each of the lock holes situated on a lock sleeve;
wherein each of the at least two lock holes is engageable by each of the at least two deformable lock tabs.
27. The medical device of claim 1, wherein the axially rigid sheath is torsionally rigid, the sheath transmitting a rotational force from the handle to the clip at a ratio of approximately 1 to 1.
28. The medical device of claim 1, further comprising:
at least two flexible links, the number of flexible links corresponding to the number of clip legs, each of the at least two flexible links extending inward radially from each corresponding clip leg to an axial position to connect to the control wire;
wherein a proximal tensile force applied to the control wire translates to a radially inward tensile force to each of the at least two flexible links, causing the clip to close.
29. The medical device of claim 1, further comprising:
a lock sleeve, the lock sleeve radially surrounding the clip legs;
wherein a distal compressive force applied to the lock sleeve moves the lock sleeve relative to the at least two clip legs, causing the at least two clip legs to close.
30. The medical device of claim 1, further comprising:
an expanded spring arrangement, the expanded spring arrangement situated distally from a pivot point on the at least two clip legs;
wherein the spring arrangement is able to apply a radially inward tensile force on the at least two clip legs to cause the at least two clip legs to close.
31. The medical device of claim 1, further comprising:
a compressed spring arrangement, the compressed spring arrangement situated proximally from a pivot point on the clip legs; and at least two tabs, the number of tabs corresponding to the number of clip legs;
wherein the compressed spring arrangement pushes radially outward on at least two tabs, the tabs translating the radially outward force via the pivot point to a radially inward force at the at least two clip legs, causing the at least two clip legs to close.
32. The medical device of claim 1, further comprising an elastic band arrangement, the elastic band arrangement including:
a first elastic band, the first elastic band situated distally from a pivot point and situated radially outward from the at least two clip legs, wherein the first elastic band applies a radially inward force to the at least two clip legs;
and a second elastic band, the second elastic band situated proximally from a pivot point and situated radially outward from at least two tabs;
wherein the second elastic band applies a radially inward force to the at least two tabs which translates via the pivot point to a radially outward force on the at least two clip legs; and wherein the control wire is uncouplably connected to the second elastic band and is able to increase the radially inward force applied by the second elastic band to the at least two tabs.
33. The medical device of claim 1, further comprising:
at least two rigid arms, the number of rigid arms corresponding to the number of clip legs, each of the at least two rigid arms extending outward radially from a central axial position to a corresponding clip leg, the at least two rigid arms uncouplably connected to the control wire, the at least two rigid arms activatable by the control wire to to apply an outward radial force to the at least two clip legs;
wherein the at least two clip legs are constructed of a material that retains an original shape after deformation, the original shape of the at least two clip legs being a closed position, the at least two clip legs elastically deformable to an open position by the at least two rigid arms.
34. The medical device of claim 1, wherein the at least two clip legs are constructed of a material that retains an original shape after deformation, the original shape of the at least two clip legs being a closed position, the at least two clip legs elastically deformable to an open position by the control wire.
35. The medical device of claim 1, wherein a proximal tensile force on the control wire is opposable by a distal compressive force on the outer sheath, the distal compressive force on the outer sheath able to close and lock the at least two clip legs.
36. The medical device of claim 1, wherein a proximal tensile force on the outer sheath is opposable by a distal compressive force on the control wire, the distal compressive force on the control wire able to close and lock the at least two clip legs.
37. The medical device of claim 1, wherein a distal termination of the control wire comprises a loop, wherein a first end and a second end of the control wire terminate at the handle.
38. The medical device of claim 1, wherein a distal termination of the control wire comprises:
at least one pill; and at least one pill well, the number of pill wells corresponding to the number of pills;
wherein each of the at least one pill is situated in the at least one pill well; and wherein the at least one pill is moveable out and away from the at least one pill well.
39. The medical device of claim 1, wherein a distal termination of the control wire comprises:
a u-ring; and a constriction of the clip;
wherein the u-ring is situated on the constriction of the clip and the u-ring is moveable out and away from the constriction.
40. The medical device of claim 1, wherein a distal termination of the control wire comprises:
a frangible link, wherein the frangible link is at least one of a wire reversibly deformed into a j-hook and a breakable link, wherein the j-hook is able to be straightened by a first predetermined tensile force; and wherein the breakable link is able to be broken by the first predetermined tensile force.
41. The medical device of claim 1, wherein a distal termination of the control wire comprises a plunger, wherein the plunger ejects the clip from an outer sleeve when a distal force is applied to the control wire.
42. The medical device of claim 1, wherein a distal termination of the control wire comprises:
a screw arrangement, wherein the handle is able to be rotated to thread a base of the clip into a female thread situated on a radially inner side of an outer sleeve, the clip able to move proximally and the at least two clip legs able to close when the base is threaded into the outer sleeve.
43. The medical device of claim 1, wherein the device is disposable.
44. A medical device for causing the hemostasis of a blood vessel for use through an endoscope, said medical device comprising:
a clip, the clip having at least two clip legs;
an outer sleeve, the outer sleeve reversibly movable with respect to the clip both to open the at least two clip legs and to close the at least two clip legs;
a control wire coupled to the outer sleeve for moving the outer sleeve relative to the clip:
an axially rigid sheath enclosing the control wire, the sheath couplable with, and uncouplable from, the clip;

a handle coupled to the axially rigid sheath; and an actuator coupled to the control wire, the control wire engageable by the actuator to move the outer sleeve to open the at least two clip legs, to close the at least two clip legs, and to uncouple the clip from the sheath.
45. A method of providing and using a medical device to deploy a clip for causing the hemostasis of a blood vessel, said method comprising:

(i) providing a medical device comprising:
a clip, wherein the clip has at least two clip legs;
a control wire coupled to the clip, the control wire reversibly operable both to open the at least two clip legs and to close the at least two clip legs, the control wire being uncouplable from the clip;
an axially rigid sheath enclosing the control wire, the sheath able to communicate a force opposing a force of the control wire;
a handle coupled to the axially rigid sheath; and an actuator coupled to the control wire, the control wire engageable by the actuator to open the at least two clip legs and to close the at least two clip legs and to uncouple the control wire from the clip;

(ii) advancing the medical device so that the clip is located at the desired deployment location; and (iii) moving the actuator to close the clip legs, and optionally to reopen and reclose the clip legs, and to uncouple the clip from the control wire.
CA2435870A 2001-10-05 2002-09-20 Through the scope endoscopic hemostatic clipping device Expired - Lifetime CA2435870C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/971,488 US7094245B2 (en) 2001-10-05 2001-10-05 Device and method for through the scope endoscopic hemostatic clipping
US09/971,488 2001-10-05
PCT/US2002/029952 WO2003030746A1 (en) 2001-10-05 2002-09-20 Through the scope endoscopic hemostatic clipping device

Publications (2)

Publication Number Publication Date
CA2435870A1 true CA2435870A1 (en) 2003-04-17
CA2435870C CA2435870C (en) 2010-02-23

Family

ID=25518453

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2435870A Expired - Lifetime CA2435870C (en) 2001-10-05 2002-09-20 Through the scope endoscopic hemostatic clipping device

Country Status (6)

Country Link
US (14) US7094245B2 (en)
EP (5) EP3023061B2 (en)
JP (1) JP4428627B2 (en)
AU (1) AU2002341757B2 (en)
CA (1) CA2435870C (en)
WO (1) WO2003030746A1 (en)

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