US20230363764A1 - Clip and clip assembly - Google Patents
Clip and clip assembly Download PDFInfo
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- US20230363764A1 US20230363764A1 US18/357,715 US202318357715A US2023363764A1 US 20230363764 A1 US20230363764 A1 US 20230363764A1 US 202318357715 A US202318357715 A US 202318357715A US 2023363764 A1 US2023363764 A1 US 2023363764A1
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- driver
- jaw
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- driving assembly
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
An endoscopic device, includes a clip assembly and a driving assembly. The clip assembly includes a first jaw, a second jaw, a pivot, a housing having an internal channel, and a release portion connecting to the first and second jaws. At least a portion of the first and second jaws is disposed within the internal channel, the first and second jaws selectively move along with the internal channel. The driving assembly includes an outer sheath, an inner tube, movably disposed within the outer sheath, and a driver, movably disposed within the inner tube, and removably received within the release portion. The driver is unbrokenly released from the release portion by a predetermined pull force. The housing and the outer sheath form a releasable handshake engagement. The inner tube extending into the housing prevents the handshake engagement from disengaging.
Description
- The present application is a continuation of U.S. application Ser. No. 16/192,202, filed Nov. 15, 2018, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62/586,617, filed on Nov. 15, 2017, and U.S. Provisional Patent Application No. 62/767,353, filed on Nov. 14, 2018, the entire disclosures of which are incorporated herein by reference.
- Hemostatic clips are used to clamp or close tissue, vessels or ducts. They are generally used to control bleeding of tissue, vessel or ducts instead of suturing or stapling. Hemostatic clips, on the market are deemed “MR Conditional” per ASTM F2503-13, which can lead to clip failure during an MRI procedure. Under FDA guidance and ASTM F2503-13, “MR Safe” means that the item poses no known hazards in all MRI environments. An MR Safe clip will be stable in patients undergoing MRI and poses no known hazards in MRI environments.
- The present application describes a clip, comprising: a grab portion at a distal end of the clip, and a release portion at a proximal end of the clip. The clip is made of electrically nonconductive or non-magnetic material. The novel aspects of this device center around the fact that the clip can grasp and hold the tissue while residing in the body being subjected to a MRI procedure. The other clips on the market react under the induced magnetic field and this reaction (which can include vibration and/or temperature increase) which can compromise the retention ability of the clip. Utilizing materials that are not influenced by the high-energy magnetic field (such as plastics, glass, ceramics or non-ferrous metals), alleviate this concern.
- The present application further describes a clip assembly, comprising a clip and a locking mechanism. The clip includes a first arm at a distal end of the clip, a second arm at the distal end of the clip, and a release portion at a proximal end of the clip. At least one of the first and second arms is movable between an open position and a closed position. The distal end of each arm has an engagement portion. The clip is made of electrically nonconductive or non-magnetic material. The locking mechanism is configured to lock the first and second arms in the closed position.
- The present application further describes a method for applying a clip to a patient, comprising 1) expose the clip at its open position; 2) adjust the driver to align the engagement portions to a treatment area; 3) clip retracts into outer sheath to close the clip; 4) push the pusher tube to move the collar past the retention mechanism; 5) extend the driver out and retract the pusher tube back; 6) release the driver from the clip.
- Features and advantages of the general inventive concepts will become apparent from the following detailed description made with reference to the accompanying drawings.
-
FIG. 1 a is a front view of an exemplary clip assembly and an exemplary driving assembly of the present subject matter; -
FIG. 1 b is a cross-sectional view of the embodiments shown inFIG. 1 ; -
FIG. 2 is a perspective view of an embodiment of the clip; -
FIG. 3 is a perspective view of another embodiment of the clip; -
FIG. 4 is a perspective view of another embodiment of the clip; -
FIG. 5 is a perspective view of another embodiment of the clip; -
FIG. 6 a is a perspective view of an embodiment of the collar; -
FIG. 6 b is a left view of the collar shown inFIG. 6 a; -
FIG. 6 c is a front view of the collar shown inFIG. 6 a; -
FIGS. 7 a-7 c shows perspective views of how the clip and the collar operate; -
FIG. 8 a is a perspective view of an embodiment of the driver shown inFIG. 1 ; -
FIG. 8 b is a front view of the driver and the clip assembly shown inFIG. 1 ; -
FIG. 9 is a perspective view of another embodiment of the driver; -
FIG. 10 shows an enlarged perspective view, an enlarged top view and an enlarged front view of the proximal release portion of a clip, which corresponds to the driver inFIG. 9 ; -
FIG. 11 is a perspective view of another embodiment of the driver; -
FIG. 12 shows an enlarged perspective view, an enlarged top view and an enlarged front view of another proximal release portion of a clip, which corresponds to the driver inFIG. 11 ; -
FIG. 13 is enlarged perspective views of the releasing portion of another embodiment of the clip and the connecter of driver; -
FIG. 14 shows a front view of another embodiment of the clip assembly and the driving assembly of the present subject matter; -
FIG. 15 shows a cross-sectional view of the clip assembly and the driving assembly shown inFIG. 14 in a fully closed position; -
FIG. 16 shows various views of the collar shown inFIG. 14 ; -
FIGS. 17 a and 17 b show front views of an introducer of the present subject matter; -
FIG. 18 shows a front view of another embodiment of a clip assembly and its driving assembly of the present subject matter in the open position; -
FIG. 19 shows the cross-sectional view of embodiments shown inFIG. 18 in the open position; -
FIG. 20 shows the cross-sectional view of the embodiment shown inFIG. 18 in the closed position; -
FIG. 21 shows the cross-sectional view of the embodiment shown inFIG. 18 in the stressed position; -
FIG. 22 shows the cross-sectional view of the embodiment shown inFIG. 18 in the released position; -
FIG. 23 shows front and top view of the switch shown inFIG. 18 ; -
FIG. 24 shows front and top views of the release portion shown inFIG. 18 ; -
FIG. 25 shows various views of the coupler shown inFIG. 18 ; -
FIG. 26 is a front view of an embodiment of a clip assembly and its driving assembly of the present subject matter; -
FIG. 27 is a transparent front view of the clip assembly and its driving assembly inFIG. 26 ; -
FIG. 28 is a front view of the clip assembly and its driving assembly inFIG. 26 , wherein the clip assembly is opened; -
FIG. 29 is a front view of the clip assembly and its driving assembly inFIG. 26 , wherein the clip assembly clips on a tissue; -
FIG. 30 is a front view of the clip assembly and its driving assembly inFIG. 26 , wherein the clip assembly clips on a tissue and the driving assembly is in the process of disengaging the clip assembly; -
FIG. 31 is a front view of the clip assembly and its driving assembly inFIG. 26 , wherein the clip assembly clips on a tissue and the driving assembly disengages the clip assembly; -
FIG. 32 is a perspective view ofFIG. 31 ; -
FIG. 33 shows a top view and a front view of a disengaging arm; -
FIG. 34 shows a front view/cross-sectional view of another embodiment in the released position; -
FIG. 35 a shows a front view/cross sectional view of another embodiment of the clip assembly and the driving assembly of the present subject matter; -
FIG. 35 b shows a front view/cross-sectional view of the embodiment shown inFIG. 35 a in the stressed position; and -
FIG. 35 c shows a front view/cross-sectional view of the embodiment shown inFIG. 35 a in the released position; -
FIG. 36 shows a perspective view of another embodiment of the clip assembly and its driving assembly while the clip assembly is closed; -
FIG. 37 shows a perspective view of the embodiment shown in theFIG. 36 while the clip assembly is open; -
FIG. 38 shows a front view/cross-sectional view of the embodiment shown inFIG. 36 ; -
FIG. 39 shows an enlarged view of a portion of the embodiment shown inFIG. 38 ; -
FIG. 40 shows a top view of the embodiment shown inFIG. 36 ; -
FIG. 41 shows another perspective view of the embodiment shown in theFIG. 36 while the clip assembly is open; -
FIG. 42 shows an enlarged view a portion of the embodiment shown inFIG. 41 ; -
FIGS. 43 a-d show various views of an embodiment of engagements; -
FIGS. 44 a-b show various views of another embodiment of engagements; -
FIGS. 45 a-c show various views of another embodiment of engagements; -
FIGS. 46 a-c show various views of another embodiment of engagements; -
FIGS. 47 a-d show various views of another embodiment of engagements; -
FIGS. 48 a-c show various views of another embodiment of engagements; -
FIGS. 49 a-c show various views of another embodiment of engagements; -
FIGS. 50 a-b show various views of another embodiment of engagements; -
FIGS. 51 a-b show various views of another embodiment of engagements; -
FIGS. 52 a-b show various views of another embodiment of engagements; -
FIGS. 53 a-c show various views of another embodiment of engagements; -
FIGS. 54 a-b show various views of another embodiment of engagements; -
FIGS. 55 a-b show various views of another embodiment of engagements; -
FIGS. 56 a-f show various views of another embodiment of engagements; -
FIGS. 57 a-b show various views of another embodiment of engagements; -
FIGS. 58 a-c show various views of another embodiment of engagements; -
FIGS. 59 a-b show various views of another embodiment of engagements; -
FIGS. 60 a-f show various embodiments of engagements; -
FIG. 61 shows another embodiment of engagements; -
FIG. 62 shows a cross-sectional view of another embodiment of engagements; -
FIG. 63 shows a perspective view of another embodiment of engagements; -
FIG. 64 shows a perspective view of another embodiment of engagements; -
FIG. 65 shows a perspective view of another embodiment of engagements; -
FIG. 66 shows a perspective view of another embodiment of engagements; -
FIG. 67 shows various views of another embodiment of engagements; -
FIG. 68 shows various views of another embodiment of engagements; -
FIG. 69 shows a perspective view of another embodiment of engagement; -
FIGS. 70 a-c show various views of the engagement shown inFIG. 69 ; -
FIGS. 71 a-c show various views of another embodiment of engagements; -
FIGS. 72 a-c show various views of the engagement without the outer sheath, shown inFIGS. 71 a -c; -
FIGS. 73 a-d show various views of another embodiment of engagements; -
FIGS. 74 a-d show various views of another embodiment of engagements; -
FIGS. 75 a-d show various views of another embodiment of engagements; -
FIGS. 76 a-b show various view of another embodiment of engagement; and -
FIGS. 77 a-c show various view of another embodiment of engagements. - This Detailed Description merely describes exemplary embodiments in accordance with the general inventive concepts and is not intended to limit the scope of the invention or the claims in any way. Indeed, the invention as described by the claims is broader than, and unlimited by, the exemplary embodiments set forth herein, and the terms used in the claims have their full ordinary meaning.
- The general inventive concepts will now be described with occasional reference to the exemplary embodiments of the invention. This general inventive concept may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the general inventive concepts to those skilled in the art.
- Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art encompassing the general inventive concepts. The terminology set forth in this detailed description is for describing particular embodiments only and is not intended to be limiting of the general inventive concepts. As used in this detailed description and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.
- Unless otherwise indicated, all numbers, such as for example, numbers expressing measurements or physical characteristics, used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless otherwise indicated, the numerical properties set forth in the specification and claims are approximations that may vary depending on the suitable properties sought to be obtained in embodiments of the invention. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the general inventive concepts are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical values, however, inherently contain certain errors necessarily resulting from error found in their respective measurements.
- A person skilled in the art should reasonably understand that the clip could be used for placement in the gastrointestinal tract for endoscopic marking; hemostasis for: mucosal/sub-mucosal defects less than about 3 cm, bleeding ulcers, arteries less than about 2 mm, polyps less than about 1.5 cm in diameter, diverticula in the colon; prophylactic clipping to reduce the risk of delayed bleeding post lesion resection; anchoring to affix jejunal feeding tubes to the wall of the small bowel; anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus; and as a supplemental closure method of luminal perforations less than about 20 mm that can be treated conservatively.
- As shown in
FIGS. 1 and 2 , the present subject matter describes a clip assembly and its driving assembly. The clip assembly comprises aclip 10 and a locking mechanism, such as acollar 20. The driving assembly (catheter assembly) 30. The drivingassembly 30 is configured to operate and release the clip assembly as desired. - As shown in
FIG. 2 , theexemplary clip 10 comprises agrab portion 12 at a distal end of theclip 10 and arelease portion 14 at a proximal end of theclip 10. In an embodiment of the clip, thegrab portion 12 comprises afirst arm 50 and asecond arm 60. In some embodiments, one of the first andsecond arms second arms second arms second arms clip 10 may comprise more than two arms, such as three arms or four arms. In some embodiments, the clip has even number of arms. The arms could be planar. The arms could also be non-planar. In some embodiments, theclip 10 has at least an 11 mm jaw opening at the open position. In some embodiments, theclip 10 may fit in, rotate and move through a scope with 2.8 mm channel at the closed position. - In an embodiment of the clip, a
distal end 54 of thefirst arm 50 comprises afirst engagement portion 56. Adistal end 64 of thesecond arm 60 comprises asecond engagement portion 66. Referring toFIGS. 7 a -7 c, when theclip 10 starts to close, the distal ends 54, 64 of the first andsecond arms second engagement portions tissue entrapment area 21 is formed near two engagement portions. - Back to
FIG. 2 , in some embodiments, the first orsecond engagement portions second engagement portions - In the embodiment of the clip shown in
FIG. 2 , at least one arm comprises aretention mechanism 16. Theretention mechanism 16 comprises aretention fin 57 disposed near thedistal end 54 of thefirst arm 50. Theretention fin 57 allows thecollar 20 to move from the proximal end of theclip 10 towards the distal end of the clip. Theretention fin 57 may contain a negative angle or other geometry such that interfacing with geometry ofcollar 20 prevents thecollar 20 from sliding away from thedistal end 54 of thefirst arm 50 so as to keep theclip 10 at the closed position and the first andsecond engagement portions - In another embodiment of the clip shown in
FIG. 3 , theretention mechanism 116 comprises afirst retention fin 157 disposed near the firstdistal end 154 of thefirst arm 150 and asecond retention fin 167 disposed near the seconddistal end 164 of thesecond arm 160. The first andsecond retention fins retention fin 57 described above. - In another embodiment of the clip shown in
FIG. 4 , theretention mechanism 216 comprises aretention fin 257, adistal stop 258, and arecess 259 between theretention fin 257 and thedistal stop 258. Theretention fin 257, thedistal stop 258, and therecess 259 are disposed near thedistal end 254 of thefirst arm 250. Theretention fin 257 has similar function as theretention fin 57 described above. The length of therecess 259 is configured to receive thecollar 20. Thedistal stop 258 prevents thecollar 20 from sliding out of the distal ends 254, 264 of the first andsecond arms - In another embodiment of the clip shown in
FIG. 5 , theretention mechanism 316 comprises first andsecond retention fin distal stops first recess 359 between thefirst retention fin 357 and the firstdistal stop 358, and asecond recess 369 between thesecond retention fin 367 and the seconddistal stop 368. The length of the first andsecond recesses collar 20. The first andsecond retention fins retention fin 57 described above. The first and seconddistal stops - A person skilled in the art should reasonably understand that besides the retention mechanisms described above, other known retention mechanisms may be used here to secure the collar.
- Referred to
FIGS. 6 a-6 c and an exemplary embodiment of theclip 10 ofFIG. 2 , thecollar 20 comprises asleeve 22 and aguide channel 28 at the center of thesleeve 22. Thearms clip 10 are able to pass through theguide channel 28 so that thecollar 20 is able to move along thearms clip 10. Theguide channel 28 has a height H and a width W. In some embodiments, the height H of theguide channel 28 is equal to or slightly higher than a height H′ of theretention fin 57 portion of theclip 10 at a closed position. In some embodiments, the width W of theguide channel 28 is equal to or slightly wider than a width W′ of theclip 10. Theguide channel 28 is configured to enable thecollar 20 to pass over and to be retained by theretention fin 57. Meanwhile, the retainedcollar 20 forces the first andsecond engagement portions guide channel 28 is also configured to prevent theclip 10 from rotating within thecollar 20. In some embodiments, theguide channel 28 is rectangular. A person skilled in the art should reasonably understand that the guide channel could be other shapes as long as the guide channel prevents the clip from rotating within the collar while the arms are movable in the guide channel. - The
collar 20 further comprises twosupport arms sleeve 22. Thesupport arms guide channel 28. When thecollar 20 locks theclip 10 and is retained by theretention fin 57, thesupport arms arms support arms arms support arms second engagement portions support arms support arms openings 26. In some embodiments, thesupport arms arms clip 10 is closed. Theopenings 26 are configured to receive tissue entrapped by the first andsecond engagement portions clip 10 is fully closed and locked. Theopenings 26 and a gap between thearms FIG. 7 c ). In some embodiments, thesupport arms arms support arms sleeve 22 comprises chamfers orfillets 23 on the outside of the proximal end of thesleeve 22. The chamfers orfillets 23 help thecollar 20 to interlock with the retention fins. - In an alternative embodiment of the clip assembly, the retention mechanism of the arm comprises a retention fin. The support arm of the collar comprises a slot disposed at an internal surface of the support arm. The slot is configured to catch the retention fin. In some embodiments, the slot is a through hole.
- Turning back to
FIGS. 1 a-1 b , as an embodiment of the present subject matter, the drivingassembly 30 comprises adriver 31, apusher tube 40, and anouter sheath 42. Thepusher tube 40 is configured to be disposed within theouter sheath 42. Thedriver 31 is configured to be disposed within thepusher tube 40. Theouter sheath 42 is configured to contain theclip 10 and thecollar 20. Thepusher tube 40 is configured to contain theclip 10 but to not be able to contain thecollar 20. In some embodiments, theouter sheath 42 prevents the coupledconnector 34 andrelease portion 14 to be decoupled when they are covered by thepusher tube 40. In some embodiments, thecollar 20 prevents the coupledconnector 34 andrelease portion 14 to be decoupled when they are covered by thecollar 20. - The driving
assembly 30 and therelease portion 14 of theclip 10 work together to operate theclip 10. Theouter sheath 42 is configured to contain theclip 10 before theclip 10 is disposed. Theouter sheath 42 is configured to move towards the proximal end of theclip 10 and to release thegrab portion 12 of theclip 10 out of theouter sheath 42. Consequently, thegrab portion 12 would become open. Thedriver 31 is configured to move or rotate theclip 10 so that theclip 10 is able to be disposed as desired. When theclip 10 is at its desired position, thedriver 31 is retracted into theouter sheath 42 and closes thegrab portion 12 of theclip 10. Thepusher tube 40 is configured to push thecollar 20 moving towards the distal end of theclip 10, and thecollar 20 consequently locks theclip 10. - As shown in
FIGS. 8 a and 8 b , thedriver 31 comprises acable 32 at a proximal end and aconnector 34 at a distal end. In some embodiments shown inFIG. 9 , thedriver 30 further comprises awire 136 between thecable 132 and theconnector 134. In an embodiment, the diameter ofwire 136 is smaller than that of thecable 132 to allow theconnector 134 to lock into therelease portion 14. Theconnector 34 is configured to interface withrelease portion 14 in a manner to have rotational control over theclip 10 so that it may be disposed as desired. - Turning back to
FIG. 2 , therelease portion 14 of theclip 10 is removable and coupled with theconnector 34 of thedriver 30. In some embodiments, therelease portion 14 comprises a receivingchamber 70 with at least one side opening from the proximal end of theclip 10. In some embodiments, theconnector 34 is a T-like shape cylinder shown inFIGS. 8 a and 8 b . The receivingchamber 70 is a T-like shape chamber and is capable to receive the T-like shape connector 34. In some embodiments, theconnector 134 is a ball shown inFIG. 9 . The receivingchamber 170 is a ball-like shape chamber shown inFIG. 10 and is capable to receive theball connector 134. In some embodiments, theconnector 234 is a cube shown inFIG. 11 . The receivingchamber 270 is a cube-like shape chamber shown inFIG. 12 and is capable to receive thecube connector 234. - In some embodiments as shown in
FIG. 13 , theconnector 334 and therelease portion 314 can be interlock connectors such as, but not limited to, hand shake connectors. Therelease portion 314 comprises a stabilizingarm 372 and atab 374. Theconnector 334 comprises apocket 336. Thepocket 336 can rest on the stabilizing arm and interlock with thetab 374. The lock can be released when needed. A person skilled in the art should reasonably understand that the configurations of theconnectors 334 and therelease portion 314 are interchangeable. - A person skilled in the art should reasonably understand that the locking mechanism may be other known designs or configurations besides the above described embodiments.
- In an alternative embodiment of the driving assembly shown in
FIGS. 14-16 , the driving assembly further comprises a coupler. The coupler is disposed at the distal end of the outer sheath. The coupler is configured to removably couple to the collar. The coupler is configured to retain the collar during multiple open/close cycles while maintaining rotatability of the clip assembly. In some embodiments, a proximal end of the collar comprises a groove. A distal end of the coupler comprises an edge configured to be engageable to the groove. The edge comprises a plurality of petals that can spread apart. When the pusher tube is advanced within the coupler, the pusher tube forces the collar to be disengaged from the coupler. The driving assembly may then be advanced to aid in the detachment of the clip assembly. In this embodiment, theclip 10 is withdrawn into thecollar 20 in order to engage theengagement portions outer sheath 42 as previous embodiments have described. - A person skilled in the art should reasonably understand that the driving assembly may be other known designs or configurations besides the above described embodiments.
- Referring to
FIGS. 1 a and 1 b , in an embodiment when a medical personnel is applying the clip assembly to a patient, the following steps may apply: 1) expose the clip at its open position; 2) adjust the driver to align the engagement portions to a treatment area; 3) the clip retracts into the outer sheath or collar to close the clip, which allows for a pre-load on the arms and increases its ability to grip the tissue; 4) push the pusher tube to move the collar passed the retention mechanism so that the clip at its fully closed position; 5) pull the outer sheath and the pusher tube back; 6) release the driver from the clip. - Referring to
FIGS. 14 and 15 , in an embodiment, when a medical personnel is applying the clip assembly to a patient, the following steps may apply: 1) expose the clip at its open position; 2) adjust the driver to align the engagement portions to a treatment area; 3) the clip retracts into the collar to close the clip, which allows for a pre-load on the arms and increases its ability to grip the tissue; 4) push the pusher tube to advance the collar out of the coupler and past the retention fins on the clip to lock the clip closed and allow for release of the clip from the driver. - The present subject matter further describes an introducer shown in
FIGS. 17 a-17 b . The introducer comprises an internal chamber with an opening at a proximal end of the introducer and an opening at a distal end of the introducer. The distal end of the introducer is configured to allow the clip assembly and the distal end of the driving assembly to pass through. The proximal end of the introducer is configured to prevent the clip assembly from passing through. Optionally, the proximal end of the introducer is configured to prevent the driving assembly from passing through. The introducer is configured to protect the clip during shipping and introduction through a biopsy valve on an endoscope. The distal end of the introducer is configured to couple into the biopsy valve. The minimum length L of the distal end of the introducer is about 5 mm. The clip assembly is configured to enter the endoscope working channel through the biopsy valve. - The internal chamber comprises an
internal surface 400 adjacent to the proximal end. In some embodiments, the internal chamber is a pod shape. The clip is configured to maintain a full open state within the internal chamber. Theinternal surface 400 is configured to force the clip to collapse as the catheter assembly is advanced from the proximal end towards the distal end. Once the clip is fully exposed from the distal end of the introducer and out of the working channel, the clip is configured to return to its fully open state. Once the clip assembly has been detached from the drive assembly, the driving assembly can be withdrawn from the endoscope. Theclip 10 may have atraumatic geometry to prevent damage to the scope while advancing trough the biopsy channel. - Referring to
FIGS. 18-19 , the present subject matter further discloses an alternative embodiment of the clip assembly and its driving assembly. The clip assembly comprises abase 500, a pair ofjaws 502, and aswitch 504. The driving assembly comprises anouter sheath 506, acoupler 508, and adriver 510. -
FIGS. 18 and 19 show the clip assembly and its driving assembly in the open position.FIGS. 20 shows the clip assembly and its driving assembly in the closed position.FIG. 21 shows the clip assembly and its driving assembly in the stressed/locked position.FIG. 22 shows the clip assembly and its driving assembly in the release/detach position. The clip assembly can freely move by the driving assembly from the open to closed position, and vice versa. Once the clip assembly enters the stressed/locked position, it cannot be opened again. The closed position allows for a pre-load on the arms and increases its ability to grip the tissue. When the clip is at the stressed/locked position, the jaws keep stressed in order to achieve a better hemostatic or other desired effect. - The
base 500 is configured to hold and position thejaws 502 and theswitch 504. Thebase 500 is configured to prevent theswitch 504 from escaping from the distal end of thebase 500. Thebase 500 comprises two halves. Thejaws 502 are configured to collect and retain tissue. Thejaws 502 are further configured to operably connect to a distal end of thebase 500. A distal portion of theswitch 504 is configured to actuate thejaws 502 between an open position and a closed position. A proximal portion of theswitch 504 comprises arelease portion 512. Therelease portion 512 is configured to removably couple with a distal end of thedriver 510. An exemplary embodiment of connection between the release portion and the driver is a T-bar connection discussed in the previous embodiments. In some embodiments, therelease portion 512 and the distal portion of theswitch 504 are separate two pieces and are connected by apin 514. The distal portion of theswitch 504 comprises a figure-8 shaped hole. The figure-8 shaped hole comprises a distal portion and a proximal portion. When thepin 514 is deposed in the distal portion of the figure-8 shaped hole, the clip assembly can be moved between the open and closed positions. When thepin 514 is deposed in the proximal portion of the figure-8 shaped hole, the clip assembly can be locked and eventually released. A person skilled in the art should understand the figure-8 shaped hole is not necessarily a through-hole and can be a slot. In some embodiment, the figure-8 shaped hole is deposed at therelease portion 512, instead of the distal portion of theswitch 504. A person skilled in the art should understand that the mechanism may not be a figure-8 shaped hole and may be a geometry which achieves similar functionality. - The
switch 504 further comprises atab 516. Thetab 516 is configured to be movable within the base while the jaws move between the open and closed positions. The tab is further configured to be pulled outside the base and to prevent theswitch 504 to move back into the base so as to lock the jaws as stressed. - A person skilled in the art should understand that the
release portion 512 and the distal portion of theswitch 504 could be made in one piece so that the pin and the figure-8 shaped hole can be eliminated. In some embodiment, the connection portion between therelease portion 512 and the distal portion of theswitch 504 is made of elastic materials so that it achieves the similar effects of the figure-8 shaped hole, which allows the clip assembly has the opened, closed, stressed/locked, and released positions. - The
coupler 508 is configured to couple with theouter sheath 506 by a barb. A person skilled in the art should understand that thecoupler 508 and theouter sheath 506 can be one piece. Thecoupler 508 is configured to removably couple to thebase 500. Thecoupler 508 is configured to retain the base 500 during multiple open/close cycles while maintaining rotatability of the clip assembly. In some embodiments, a proximal end of thebase 500 comprises a groove. A distal end of thecoupler 508 comprises an edge configured to be engageable to the groove. The edge comprises a plurality of petals that can spread apart. Thecoupler 508 further comprises abottleneck 520. Thedriver 510 comprises awedge 522. Thewedge 522 is configured to push thebottleneck 520 when thedriver 510 pulls back and tries to detach the clip assembly from the driving assembly. By pushing thebottleneck 520, thewedge 510 forces the petals of thecoupler 508 apart. Then the edge and the groove are disengaged. The clip assembly therefore is detached. - Referring to
FIGS. 26-33 , the present subject matter further discloses an alternative embodiment of the clip assembly and its driving assembly. The clip assembly comprises afirst jaw 602, asecond jaw 604, afirst pivot 606, and anelastomeric band 608. Thefirst jaw 602 is pivotally connected to thesecond jaw 604 at thefirst pivot 606. The first jaw comprises a distal arm and a proximal arm. The second jaw comprises a distal arm and a proximal arm. Although both the first and second jaws are described as moving jaws above, a person skilled in the art should readily understand that the first jaw may be a stationary jaw. - The
elastomeric band 608 connects the distal arms of the first and second jaws and allows for normally closed first and second jaws. In some embodiments, the elastomeric band connects between the proximal arms of the first and second jaws. In some other embodiments, one elastomeric band connects between the distal arms of the first and second jaws; another elastomeric band connects between the proximal arms of the first and second jaws. The elastomeric band may be a ring around the first and second jaws, a band between the first and second jaws, or any other connection structures between the first and second jaws. In some embodiments, the elastomeric band is eliminated and the pivot comprises a common elastomeric structure so that the first and second jaws are normally closed. - Each proximal end of the first and second jaws comprises a
receiver 610. Thereceiver 610 is configured to removably receive the driving assembly so that the driving assembly may drive the clip assembly to be opened or closed. - The driving assembly comprises an
outer sheath 612, afork 614, and adriver 616. Thefork 614 is disposed within theouter sheath 612. The distal ends of thefork 614 are extended from the distal end of theouter sheath 612. The proximal end of thefork 614 is connected to thedriver 616. In one embodiment, thefork 614 is pivotally connected to theouter sheath 612 at asecond pivot 628. - Each of two distal ends of the
fork 614 comprises anengagement portion 618. Theengagement portion 618 is configured to engage with thereceiver 610 of the clip assembly. When thedriver 616 is pushed towards its distal direction, the distal ends of theforks 614 are opened, and consequently the clip assembly is opened. When thedriver 616 is pulled towards its proximal direction, the distal ends of thefork 614 are closed, and consequently the clip assembly is closed. The elastomeric band generates the closing force to achieve the hemostatic effect. In some embodiments, the closing force is about 150 to 400 g. - Referring to
FIG. 34 , the present subject matter further discloses an alternative embodiment of the clip assembly and its driving assembly. In this embodiment, a single lever arm in thefork assembly 614 is used to open the clip assembly. Thefirst pivot 606 is connected to theouter sheath 612 until deployment. After deployment, thefirst pivot 606 remains with the clip assembly. Alternatively, the clip assembly may detach from the fork at adifferent pivot 615 allowing the linkage arms to remain loosely attached to the clip assembly. A person skilled in the art should reasonably understand that the fork (assembly) can be any known structures of which the distal ends are opened when the drive mechanism is advanced in the distal direction. A person skilled in the art should reasonably understand that detachment of the clip assembly from thefork assembly 614 and/or thereceiver 610 can be achieved by various methods such as mechanical detachment or by applying electrical current to sever the joints and that detachment may be achieved at any linkage point in thefork assembly 614. In some embodiments, thedriver 616 is metal and the fork assemble 614 is plastic. Thedriver 616 may be electrically heated and is able to melt at least a part of thefork assembly 614 to detach thefork assembly 614. In some embodiments, theouter sheath 612 is mechanically breakable. In some embodiments, thepivot 615 is mechanically breakable. In some embodiments, thedriver 616 is mechanically breakable at a point near theouter sheath 612. A person skilled in the art should understand that the above described detachment may be applied to other embodiments in the present application. - In some embodiments, the
fork 612 comprises asymmetrical arms. In some embodiments, thefork 612 comprises the distal arms with different length. In some embodiments, thefork 612 comprises the proximal arms with different length. - The
engagement portion 618 of thefork 614 comprises adetent 620. Thedetent 620 may be hemispherical or any other suitable shape. Thereceiver 610 comprises apocket 624 for thedetent 620 to engage with. In some embodiments, theengagement portion 618 comprises aslot 622 to help thedetent 620 to be compressed and to detach from thereceiver 610. In some embodiments, theengagement portion 618 comprises abump 626 to aide in detaching thereceiver 610. When the clip assembly clips on a tissue, the tissue prevents the clip assembly from being fully closed. When the fork is further closed, the bump presses against the edges of thepocket 624 and aides to the disengagement. - Referring to
FIGS. 35 a, b & c, the present subject matter further discloses an alternative embodiment of the clip assembly and its driving assembly. The clip assembly comprises aclip 710 and alocking mechanism 720, driving assembly (catheter assembly) 730,release portion 714, pair ofjaws 702. -
FIG. 35 a shows the clip assembly and its driving assembly in the open position.FIG. 35 b shows the clip assembly and its driving assembly in the closed/stressed/locked position.FIG. 35 c shows the clip assembly and its driving assembly in the release/detach position. The clip assembly can freely move by the driving assembly from the open to closed position, and vice versa. Once the clip assembly enters the stressed/locked position, it cannot be opened again. - The
release portion 714 of theclip 710 is removably coupled with theconnector 734 of thedriver 731. In some embodiments, therelease portion 714 comprises a receivingchamber 770 with at least one side opening from the proximal end of theclip 710. In some embodiments, theconnector 734 is a T-like shape cylinder and receivingchamber 770 is a T-like shape chamber and is capable to receive a T-like shape connector. In some embodiments, theconnector 734 is a ball and the receivingchamber 770 is a ball-like shape chamber and is capable to receive theball connector 734. In some embodiments, theconnector 734 is a cube shown and the receivingchamber 770 is a cube-like shape chamber and is capable to receive thecube connector 734. Those who are skilled in the art should reasonably understand that the shape of theconnector 734 and the receivingchamber 770 can be any geometry which allows for a suitable connection and disengagement. - Referring to
FIG. 35 b , thejaws 702 are connected by apivot 728. Those skilled in the art should reasonably understand that the pivot may comprise of one or more pivot points and may be a separate piece or comprised of feature within thejaws 702. Thepivot 728 may be comprised of any suitable material allowing for the closure of thejaws 702. TheJaws 702 may be comprised of one or more pieces linked via thepivot 728. Thepivot 728 may contain additional components necessary for the operation of the assembly. - The
elastomeric band 708 connects the proximal arms of thejaws 702 and allows for normally opened positioned jaws. The elastomeric band may be a ring around the first and second jaws, a band between the first and second jaws, or any other connection structures between the first and second jaws. In some embodiments, the elastomeric band is eliminated and the pivot comprises a common elastomeric structure so that the first and second jaws are normally opened. In some embodiments, the elastomeric band is eliminated and the jaws are mechanically connected to the locking mechanism allowing for controlled opening and closing of the jaws. - When closing, the driving
assembly 730 causes thelocking mechanism 720 to spread the proximal end of theclip assembly 710 thereby bringing thegrab portion 712 of thejaws 702 together creating of atissue entrapment area 721. This is accomplished via thepivot 728 which causes theconnector 734 to disengage from the receivingchamber 770 of therelease portion 714. This disengagement may be comprised of a break-away feature such that theconnector 734 releases from receivingchamber 770 after theclip assembly 710 is in its stressed/locked state. In some embodiments, thelocking mechanism 720 comprises of aretention pocket 729 on the outer portion. Theretention pocket 729 interlocks with theretention fins 757 of theretention mechanism 716 thus locking theclip 710 in a closed position. A person skilled in the art should reasonably understand that the locking mechanism may be other known designs or configurations besides the above described embodiments which accomplish the task of spreading the proximal arms of thejaws 702. - Referring to
FIG. 35 c , once theclip assembly 710 is in a stressed/locked position, the drivingassembly 730 disengages from thelocking mechanism 720. - Referring to
FIGS. 36-40 , the present subject matter further discloses an alternative embodiment of theclip assembly 800 and its drivingassembly 900. Theclip assembly 800 comprises afirst jaw 802, asecond jaw 804, apivot 806, arelease portion 808, and ahousing 820. In one embodiment, thefirst jaw 802 and thesecond jaw 804 are pivotally connected to thepivot 806. A person skilled in the art should understand that thepivot 806 may be removably attached to or a part of thefirst jaw 802, thesecond jaw 804, arelease portion 808, or any combination thereof. Thehousing 820 comprises aninternal channel 822. At least a portion of both thefirst jaw 802 and thesecond jaw 804 is disposed within theinternal channel 822. Thefirst jaw 802 and thesecond jaw 804 are configured to move along with theinternal channel 822 between a fully closed position and a fully opened position. When the drivingassembly 900 or a driver of the drivingassembly 900 is pushed towards its distal direction, thefirst jaw 802 and thesecond jaw 804 open. When the drivingassembly 900 or the driver of the drivingassembly 900 is pulled towards its proximal direction, thefirst jaw 802 and thesecond jaw 804 close. Although both the first and second jaws are described as moving jaws above, a person skilled in the art should readily understand that the first jaw may be a stationary jaw. A person skilled in the art also should understand that theclip assembly 800 may comprise more than two jaws. - In some embodiments, the
housing 820 comprises adistal stopper 824. Thedistal stopper 824 is disposed at or near thedistal end 836 of theinternal channel 822. In some embodiments, thedistal stopper 824 is a pin removably passing through thehousing 820. Thedistal stopper 824 is configured to force thefirst jaw 802 and thesecond jaw 804 fully open when the release portion moves to its most distal position. Thedistal stopper 824 is also configured to prevent thefirst jaw 802 and thesecond jaw 804 from completely falling out of thehousing 820. Thedistal stopper 824 is also configured to prevent thefirst jaw 802 and thesecond jaw 804 from crossing the center plane bisecting the two arms. - In some embodiments, the
housing 820 comprises aproximal stopper 826. Theproximal stopper 826 is disposed at or near theproximal end 834 of theinternal channel 820. In some embodiments, theproximal stopper 826 is a ring attached to theinternal channel 822. Theproximal stopper 826 may prevent therelease portion 808 from falling out of thehousing 820. Theproximal stopper 826 may provide a leverage surface other than the jaws to pull against when trying to dislodge the T-tag. Stresses can be balanced between that proximal stopper or the step in the jaws depending on the position of this step. In some embodiments, all force could be on the proximal stopper. In some embodiments, all force could be on the jaws. In some embodiments, all force could be shared between the proximal stopper and the jaws. - At least a portion of the
release portion 808 is proximal to thefirst jaw 802 and thesecond jaw 804. In some embodiments, therelease portion 808 is pivotally connected to thepivot 806. In some embodiments, therelease portion 808 is fixed to thepivot 806. In some embodiments, therelease portion 808 is fixed to either arm or both arms. In some embodiments, thefirst jaw 802 and thesecond jaw 804 are disposed at each side of at least a portion of therelease portion 808. Therelease portion 808 is configured to removably receive the drivingassembly 900 so that the drivingassembly 900 or the driver of the drivingassembly 900 may drive theclip assembly 800 to be opened or closed. - In some embodiments, at the partially or fully closed positions, the
first jaw 802 and thesecond jaw 804 achieve hemostatic effort. In some embodiments, thefirst jaw 802 and thesecond jaw 804 bite on the target tissue. The friction between at least one of the first andsecond jaws internal channel 822 cause the first andsecond jaws - Referring to
FIGS. 41-42 , when theclip assembly 800 is in the open position, the jaws may be able to rotate, causing misalignment or even binding which would prevent the jaws from retracting. In some embodiments, thehousing 820 comprises at least onealignment slot 828. In some embodiments, thehousing 820 comprises two alignment slots. Thealignment slot 828 is configured to receive at least a portion of thefirst jaw 802 when thefirst jaw 802 in a non-closed position. In some embodiments, thealignment slot 828 is configured to receive analignment rib 830 of thefirst jaw 802. Thealignment slot 828 prevents thefirst jaw 802 from unintended misalignment or rotation. In some embodiments, thehousing 820 comprises twoalignment slots 828 for both thefirst jaw 802 and thesecond jaw 804. - Referring to
FIGS. 63-68 , in some embodiments, thealignment slot 828 is disposed at theinternal channel 822. Thealignment slot 828 is configured to receive at least a portion of the releasingportion 808. Thealignment slot 828 prevents the releasingportion 808 from rotating within theinternal channel 822, and therefore prevents the first and second jaws from unintended misalignment or rotation. In some embodiments, theinternal channel 822 with thealignment slots 828 receives therelease portion 808 withalignment ribs 830. In some embodiments, theinternal channel 822 and thealignment slots 828 together form a non-cylindrical geometry, which receives a corresponding non-cylindrical geometry of therelease portion 808. In some embodiments, thealignment slots 828 are disposed on thehousing 820 and receivepins 832 on therelease portion 808. In some embodiments, thealignment slots 828 are disposed on thehousing 820 and receive thepivot 806. A person skilled in the art should understand that the slot does not need to be visible from the outside of the housing; the slot does not to be on both sides; the pins do not need to be on the both sides; and the ribs do not need to be on the both sides. - A person skilled in the art should understand the shape of the housing 820 (or the internal channel 822) can be cylinder, cuboid, diamond, or other suitable geometries, as long as the releasing
portion 808 has a corresponding geometry. - The driving
assembly 900 comprises anouter sheath 902, aninner tube 904, and adriver 906. Theinner tube 904 is movably disposed within theouter sheath 902. Thedriver 906 is movably disposed within theinner tube 904. Thedriver 906 removably connects to therelease portion 808 to form a driving engagement. Thedriver 906 is configured to move between its distal direction and its proximal direction to control theclip assembly 800 between open and closed. In some embodiments of the driving engagement, upon a predetermined pull force, thedriver 906 separates from therelease portion 808. Such predetermined pull force is larger than the force causing theclip assembly 800 closed and achieving a hemostatic effect. In some embodiments, thedistal end 908 of theouter sheath 902 and theinner tube 904 form a housing engagement with theproximal end 834 of thehousing 820. A person skilled in the art should understand that only one of the driving and housing engagements is needed in some embodiments of the device. Referring toFIG. 39 , in some embodiments, thedistal end 908 is configured to fully rotate 360 degrees without separating from the other part of theouter sheath 902. In some embodiments, an interlocking rib and channel design comprised of two opposing ledges keep the distal end from disengaging yet allowing for circular rotation. - Referring
FIG. 62 , a person skilled in the art should understand that the driving engagement and/or the housing engagement provide a bidirectional controllable rotation. For bidirectional controllable rotation, there must be interfacing surfaces between the clip assembly and the driving assembly that are not perpendicular to the long axis of the clip assembly. This may be a combination of flat surfaces and/or curved surfaces. This will be known as the total rotational engagement surface. In some embodiments of rotation engagements, each half of the engagement portion must have a feature, or set of features, with at least two opposing rotational engagement surfaces, that are located on either side of a center plane (that is coincidental with the long axis of the clip assembly) to have controllable rotation in two directions. For unidirectional rotation, only one rotational engagement surface may be required. An engaged rotational engagement is configured to rotate and disengage. - A person skilled in the art should understand that, to translate forces distally and proximally (for example, open and close the jaws, move the clip assembly distally or proximally), the driving engagement and/or the housing engagement must provide interfacing surfaces. These interfacing surfaces are not parallel to the long axis of the assemblies. This may be a combination of flat surfaces and/or curved surfaces. This will be known as the total push/pull engagement surface. In some engagements, each half of the engagement portion must have a feature, or set of features, with at least two opposing total push/pull engagement surfaces. An engaged engagement is configured to move translationally and disengage. A person skilled should readily understand that the structures of the driving engagement and the housing engagement are often interchangeable with/without some adaptive modifications. The engagement described in this application should be understood by the person skilled as used for the driving engagement and/or the housing engagement.
- Referring
FIGS. 40, 44 a-b, 46 a-c, 47 a-d, in some embodiments, thedistal end 910 of thedriver 906 comprises atag 910. In some embodiments, thetag 910 is a T-tag. A person skilled in the art should understand that thehook 910 could also be a Y, one sided L or J bend, an eyelet, or other suitable shapes. Thetag 910 is received in the releasingportion 808 to form the driving engagement. Thetag 910 promotes a stabilized push and pull motions under normal use. Once disengagement is required, the two t-shaped wires move radially inward, which allows the wires to slip out from therelease portion 808, thus full disengagement is achieved. Thetag 910 also helps for the rotation control. - Referring to
FIGS. 59 a-b , in some embodiments, the engagement between thedistal end 908 and theproximal end 834 is a handshake engagement. Thedistal end 908 and theproximal end 834 each have a handshake half. Once thedistal end 908 and theproximal end 834 engage, theinner tube 904 extends into theproximal end 834 of thehousing 820 and prevents thedistal end 908 and theproximal end 834 from disengaging. Once theinner tube 904 is retracted out of theproximal end 834, the engageddistal end 908 and theproximal end 834 are able to be separated. - The
inner tube 904 that is retracted to allow disengagement must have a diameter such that thedistal end 908 and theproximal end 834 remain together until purposefully removed. The combined clearance of both inner diameters ID of the handshake halves with the outer diameter OD of theinner tube 904 must be less than the height H of the total engagement surface when measured perpendicular to the long axis of theclip assembly 800. - Referring
FIGS. 60 a-f and 61, a person skilled in the art should understand that all interactions may have symmetrical geometries for the clip assembly and the driving assembly, or asymmetrical. All geometries on either side may be symmetrical across a center plane, or asymmetrical. Geometry to promote ready disengagement when removing the inner tube may be in the form of back-angles, clearances, or any other suitable geometry for this purpose. Geometries used may or may not be visible from the outside of the clip assembly and the driving assembly and may be within outer material. Interfacing surfaces of the handshake and the inner tube do not need to be cylindrical and do not have to be matching shapes. - A person skilled in the art should understand that the engagements between the clip assembly and the driving assembly are not limited to the above discussed embodiments. Some other exemplary embodiments as follows:
- Referring to
FIGS. 43 a-d , another embodiment of the engagement comprises a driving wire wound on the release portion. The driving wire is configured to be pulled with a predetermined force and be straightened to be disengaged. - Referring to
FIGS. 45 a-c , another embodiment of the engagement comprises a pull wire and a release portion with a ball. A hole of the outer sheath is configured to receive or release the ball of the release portion. However, the hole cannot release the ball of the release portion with the pull wire inserting through the hole. In another embodiment, the hole is on the release portion and the ball is included in the driving assembly. A person skilled in the art should understand that the ball can be replaced by any other larger geometry that cannot be removed through the hole without the pull wire being removed. - Referring to
FIGS. 48 a-c , another embodiment of the engagement is a ball detent connection. - Referring to
FIGS. 49 a-c , another embodiment of the engagement comprises L-arms and the inner tube. The L-arms removably attached to the housing of the clip assembly. The inner tube may move in the distal direction and push on the L-arms and forces the L-arms to move inward and disengage. The L-arms may be attached to the housing by taper, friction, or overmold. The L-arms may also be free floating with a geometry that maintains engagement in the absence of the inner tube. - Referring to
FIGS. 50 a-b , another embodiment of the engagement comprises a clip connector traveling on tracks that moves radially inward to disengage from thehousing 820. - Referring to
FIGS. 51 a-b , another embodiment of the engagement comprises a screw connection between the driver and the release portion. The predetermined force to unscrew this connection must be less than a force that may render the device ineffective. - Referring to
FIGS. 52 a-b , in another embodiment of the engagement, the housing comprises two slots or holes. The driver comprises two foldable projects only when the driver rotates clockwise. The projects insert into the slots when rotated counterclockwise, so as to maintain the engagement. When the projects rotate clockwise, the projects retract from the slots, and the driver is able to be disengaged. - Referring to
FIGS. 53 a-c , in another embodiment of the engagement, a switch bar is configured to rotates in slots disposed on the outer sleeve and to release the driver from the geometry in the middle of the switch bar. - Referring to
FIGS. 54 a-b , in another embodiment of the engagement, the driver comprises a C ring and the release portion comprises a hole. When engaged, the C ring is inserted through the hole of the release portion. The C ring is configured to be pulled until the clip assembly falls off. - Referring to
FIGS. 55 a-b , in another embodiment of the engagement, the release portion of the clip assembly comprises a hole. The inner tube inserts into the hole and uses constant suction to hold the release portion. Once the suction is turned off, the clip assembly will disengage. - Referring to
FIGS. 56 a-f , in another embodiment of the engagement, a cotter pin is used to tether the driver and the release portion. By removing the cotter pin, the clip assembly would disengage. - Referring to
FIGS. 57 a-b , in another embodiment of the engagement, the release portion is over fit with the outer sheath. A lever is used to eject the release portion. A person skilled in the art should understand that, instead of the lever, the outer tube or a pushing wire may be used to eject the release portion. - Referring to
FIGS. 58 a-c , in another embodiment of the engagement, the release portion comprises a socket. The driver comprises a deflectable balloon. The balloon inserts into the socket and is inflated so that the engagement maintains. The inflated balloon in the socket is deflated to disengage. One skilled in the art should also realize that the balloon could be configured to grasp a feature from the outside or in a manner where inflation, rather than deflation creates the component release. - Referring to
FIGS. 69 and 70 a-c, another embodiment of the engagement comprises at least one angled ramp. The housing comprises at least one flexible tab. The outer sheath comprises retention slots and at least one groove. The flexible tab fits into and locks with the retention slot. The groove is substantially along the center axis of the outer sheath. The angled ramp is configured to move along the groove. When the release of the engagement is required, the angled ramp drives the locking tab toward the center axis to the point where the tab is no longer engaged in the retention slot. Consequently, the engagement is able to separate. - Referring to
FIGS. 71 a-c and 72 a-c , another embodiment of the engagement comprises two cams in rotational alignment with each other, a retention bar to hold the cams. In one embodiment, the retention bar is a rail that is an integral part of the outer sheath. The retention bar maintains alignment between the two cams and prevents them from rotating. Once the two cams are pull distally (in a direction to close and lock the jaws), the proximal cam will have been pulled into a position, past the retention bar, which allows the proximal cam to rotate with respect to the distal cam and release. The cam angle, in conjunction with force in the proximal direction, causes the rotation and once the proximal cam rotates sufficiently it is free of the lock and releases. - Referring to
FIGS. 73 a-d , in another embodiment of the engagement, the outer sheath and the housing are made with fine cuts which have undercuts which hold them together. The engagement comprises an invertible washer. The washer expands under load and causes the end of the outer sheath to expand to disengage from the housing. - Referring to
FIGS. 74 a-d , in another embodiment of the engagement, the outer sheath and the housing have a match pattern. The interfacing ends allow for a flat and flexible washer to secure the two components together. Once the drive system is pulled through the washer, the components are separated. The washer is then retained with the driving assembly. - Referring to
FIGS. 75 a-d , in another embodiment of the engagement, the housing comprises at least one inset tab. The outer sheath comprises at least one bendable arm. The inset tab and the bendable arm are fit to each other. The inner tube or the driver is pulled in a direction to bend the arm and disengage the tabs. This in turn releases the housing from the outer sheath. - Referring to
FIGS. 77 a-c , in another embodiment of the engagement, the inner tube (or the driver) comprises two aligned bosses. The aligned bosses join the outer sheath and the housing together until the inner tube is pulled out of the housing and into the outer sheath. At this point, the housing is released. - Referring to
FIGS. 76 a-b , a locking mechanism is discussed. This locking mechanism helps to hold the clip assembly in the final and closed position shown asFIG. 76 b . All actions are axial and radial. - Some embodiments of the clip assembly are disclosed in the U.S. Provisional Application No. 62/586,515, filed on Nov. 15, 2017, titled “END EFFECTORS ACTUATION PLATFORM,” and the U.S. Provisional Application No. 62/586,573, filed on Nov. 15, 2017, titled “AVULSION FORCEPS,” which are specifically and entirely incorporated by reference herein.
- A person skilled in the art should reasonably understand that in order to be MR Safe, some embodiments of the clip assembly described above are made of electrically nonconductive or non-magnetic material. The clip assembly has all components that are left in the patient.
- A person skilled in the art should reasonably understand that at least one or multiple portions of the device may be constructed of or coated in a radio-opaque or radio-visible material to be identifiable with medical imaging technologies.
- A person skilled in the art should reasonably understand that the above designs are readily applied to a metal clip or other metal devices.
- While various inventive aspects, concepts and features of the general inventive concepts are described and illustrated herein in the context of various exemplary embodiments, these various aspects, concepts and features may be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the general inventive concepts. Still further, while various alternative embodiments as to the various aspects, concepts and features of the inventions (such as alternative materials, structures, configurations, methods, circuits, devices and components, alternatives as to form, fit and function, and so on) may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts or features into additional embodiments and uses within the scope of the general inventive concepts even if such embodiments are not expressly disclosed herein. Additionally, even though some features, concepts or aspects of the inventions may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, exemplary or representative values and ranges may be included to assist in understanding the present disclosure; however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated. Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of an invention, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts and features that are fully described herein without being expressly identified as such or as part of a specific invention. Descriptions of exemplary methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated.
Claims (20)
1. An endoscopic device comprising:
a clip assembly comprising:
a first jaw;
a second jaw; and
a release portion connecting a proximal portion of the first jaw and a proximal portion of the second jaw, the release portion including an opening extending through a proximal end of the release portion; and
a driving assembly operably interfacing with the clip assembly, the driving assembly comprising:
a sheath; and
a driver movably disposed within the sheath, a distal portion of the driver operably extending through the opening of the release portion;
wherein at least one jaw is movable between an open position and a closed position via movement of the driver relative to the sheath; and
wherein the distal portion of the driver is configured to operatively couple the driving assembly with the clip assembly when the distal portion of the driver is disposed distally from the opening of the release portion and is configured to be proximally retracted through the opening of the release portion via a predetermined proximal pull force to decouple the driving assembly from the clip assembly.
2. The endoscopic device of claim 1 , wherein the distal portion of the driver includes a tag with a leg extending radially outwardly configured to operably retain the driver in the release portion.
3. The endoscopic device of claim 2 , wherein the leg of the driver is configured to move radially inward via the predetermined proximal pull force such that the distal portion of the driver may be retracted through the opening of the release portion.
4. The endoscopic device of claim 1 , wherein the distal end of the driver comprises a ball configured to operably retain the distal portion of the driver in the release portion distally from the opening.
5. The endoscopic device of claim 4 , further comprising a pull wire operably extending through the opening of the release portion;
wherein the pull wire prevents the ball from retracting through the opening when the pull wire extends through the opening and allows the ball to be retracted through opening when the pull wire is proximally retracted from the opening.
6. The endoscopic device of claim 1 , wherein a laterally outer portion of at least one jaw includes a retention fin configured to prevent a collar from sliding away from a distal end of the at least one jaw.
7. The endoscopic device of claim 1 , wherein the distal end of the driver is compressible between a first diameter that is larger than the opening and a second diameter that is smaller than the opening.
8. The endoscopic device of claim 1 , wherein the predetermined pull force is greater than a force which moves the at least one jaw from the open position to the closed position.
9. An endoscopic device comprising:
a clip assembly comprising:
a first jaw and a second jaw, wherein at least one jaw is operable to move between an open position and a closed position;
a housing having an internal channel and a longitudinal groove at a proximal end of the housing, wherein the at least one jaw is operable to move along the internal channel; and
a driving assembly operably interfacing with the clip assembly, wherein the driving assembly includes:
an outer sheath operably coupled with the housing, the outer sheath having a longitudinal groove at a distal end of the outer sheath;
an inner tube movably disposed within the outer sheath and at least one boss extending radially outwardly and slidably disposed within the longitudinal grooves of the housing and the outer sheath; and
a driver movably disposed within the inner tube; and
wherein the at least one jaw is longitudinally movable by movement of the driver relative to the inner tube and is movable between the open position and the closed position by movement of the inner tube relative to the outer sheath; and
wherein the at least one boss maintains the coupling between the housing and the outer sheath when the at least one boss is disposed in the longitudinal grooves of the housing and the outer sheath and decouples the outer sheath from the housing when the at least one boss is proximally retracted from the longitudinal groove of the housing.
10. The endoscopic device of claim 9 , wherein the at least one boss prevents rotation of the housing relative to the outer sheath when the at least one boss is disposed in the longitudinal grooves of the housing and the outer sheath.
11. The endoscopic device of claim 9 , wherein the inner sheath abuts an inner surface of the outer sheath and an inner surface of the housing when the at least one boss is disposed in the longitudinal grooves of the housing and the outer sheath.
12. The endoscopic device of claim 9 , wherein the at least one boss comprises two aligned bosses.
13. An endoscopic device comprising:
a clip assembly comprising:
a first jaw;
a second jaw; and
a housing having an internal channel and slots on opposite sides of the internal channel, wherein the at least one jaw is operable to move along the internal channel; and
a driving assembly operably interfacing with the clip assembly, the driving assembly comprising:
a sheath; and
a driver movably disposed within the sheath, a distal end of the driver having two arms extending radially outwardly and each being operably disposed in one of the slots of the housing to couple the clip assembly to the driving assembly;
wherein at least one jaw is movable between an open position and a closed position via movement of the driver relative to the sheath;
wherein the sheath is distally movable relative to the driver to abut the arms of the driver; and
wherein distal movement of the sheath at a predetermined force move the arms radially inwardly to retract from the slots of the housing to decouple the clip assembly from the driving assembly.
14. The endoscopic device of claim 13 , wherein each of the arms of the driver couple with the housing via friction.
15. The endoscopic device of claim 13 , wherein each of the arms of the driver couple with the housing via a taper.
16. The endoscopic device of claim 13 , wherein a proximal portion of each arm extends distally and radially outward and a distal end of each arm extends substantially perpendicular to a longitudinal axis of the driver; and
wherein the distal end of each arm operably engages one of the slots of the housing.
17. An endoscopic device comprising:
a clip assembly comprising:
a first jaw;
a second jaw; and
a release portion connecting a proximal portion of the first jaw and a proximal portion of the second jaw, the release portion having at least one first aperture oriented perpendicularly to the jaws near a proximal end of the release portion; and
a driving assembly operably interfacing with the clip assembly, the driving assembly comprising:
a sheath;
a driver movably disposed within the sheath, the driver having a second aperture oriented perpendicular to a longitudinal axis of the driver near a distal end of the driver;
a link pin operably disposed through the at least one first aperture and the second aperture to operably couple the clip assembly with the driving assembly;
wherein at least one jaw is movable between an open position and a closed position via movement of the driver relative to the sheath; and
wherein proximal retraction of the driver at a predetermined pull force retracts the link pin from the at least one first aperture and the second aperture to decouple the clip assembly from the driving assembly.
18. The endoscopic device of claim 17 , wherein the link pin is a cotter pin.
19. The endoscopic device of claim 17 , wherein the proximal end of the release portion comprises a fork with two legs, each leg having one first aperture; and
wherein the link pin is operably disposed through each of the first apertures and the second aperture to operably couple the clip assembly with the driving assembly.
20. The endoscopic device of claim 17 , wherein proximal retraction of the driver at the predetermined pull force bends the link pin out of the first apertures to decouple the clip assembly from the driving assembly.
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US18/357,715 US20230363764A1 (en) | 2017-11-15 | 2023-07-24 | Clip and clip assembly |
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US18/357,715 US20230363764A1 (en) | 2017-11-15 | 2023-07-24 | Clip and clip assembly |
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US11413030B2 (en) * | 2018-11-08 | 2022-08-16 | William MONTROSS | Montross button |
WO2020136906A1 (en) * | 2018-12-28 | 2020-07-02 | オリンパス株式会社 | Ligation device and engaging method |
CN113316424A (en) * | 2019-01-03 | 2021-08-27 | 奥林巴斯株式会社 | Holding device for large defects, perforations and fistulas |
AU2019452937B2 (en) * | 2019-07-03 | 2023-10-05 | Anrei Medical (Hangzhou) Co., Ltd. | Clamp device used in cooperation with endoscope, and clamping portion of clamp device |
WO2021156930A1 (en) * | 2020-02-04 | 2021-08-12 | オリンパス株式会社 | Applicator and ligation device |
US20230294307A1 (en) * | 2020-09-11 | 2023-09-21 | The Board Of Trustees Of The Leland Stanford Junior University | Devices and methods directed to sensing using synthetic materials |
EP3984471A1 (en) * | 2020-10-16 | 2022-04-20 | Olympus Medical Systems Corp. | Bendable clip device |
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JP4472217B2 (en) | 2000-10-16 | 2010-06-02 | オリンパス株式会社 | Biological tissue clip device |
JP4097924B2 (en) * | 2001-02-05 | 2008-06-11 | オリンパス株式会社 | Biological tissue clip device |
JP4059656B2 (en) * | 2001-03-07 | 2008-03-12 | オリンパス株式会社 | Biological tissue clip device |
JP4827304B2 (en) * | 2001-03-14 | 2011-11-30 | オリンパス株式会社 | Biological tissue clip device |
US7727247B2 (en) * | 2002-08-21 | 2010-06-01 | Olympus Corporation | Living tissue ligation device |
DE10334083A1 (en) * | 2003-07-26 | 2005-02-24 | Carl Stahl Gmbh | Method and device for endoscopic application of closing medical clips |
JP4758173B2 (en) * | 2004-12-24 | 2011-08-24 | オリンパス株式会社 | Ligation device |
US8080021B2 (en) | 2005-01-11 | 2011-12-20 | Boston Scientific Scimed, Inc. | Multiple clip deployment magazine |
AU2007225266B2 (en) * | 2006-03-10 | 2013-06-06 | Cook Medical Technologies Llc | A clip device and a protective cap for drawing the target tissue into it before the clip is deployed |
WO2008070486A2 (en) * | 2006-12-05 | 2008-06-12 | Wilson-Cook Medical Inc. | Combination therapy hemostatic clip |
US8162959B2 (en) | 2007-05-03 | 2012-04-24 | Boston Scientific Scimed, Inc. | Single stage hemostasis clipping device |
JP5885506B2 (en) * | 2009-02-17 | 2016-03-15 | ザ ボード オブ トラスティーズ オブ ザ レランド スタンフォード ジュニア ユニバーシティー | Suture device and method |
JP5588711B2 (en) * | 2010-03-30 | 2014-09-10 | 富士フイルム株式会社 | Ligation device |
CN103124530B (en) * | 2010-09-22 | 2016-03-30 | 富士胶片株式会社 | Apparatus for ligating and the clip unit used in this apparatus for ligating |
JP5343113B2 (en) * | 2011-09-15 | 2013-11-13 | 富士フイルム株式会社 | Clip unit and ligating apparatus using the same |
EP2819595A1 (en) | 2012-02-28 | 2015-01-07 | Boston Scientific Scimed, Inc. | Clip applier |
CN107371362B (en) | 2015-05-19 | 2020-05-05 | 奥林巴斯株式会社 | Clamp device |
CN107072671B (en) * | 2015-05-27 | 2019-08-30 | 奥林巴斯株式会社 | Treatment instrument for endoscope |
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WO2019099698A1 (en) | 2019-05-23 |
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