Tissue alignment for surgical closure
11832818 · 2023-12-05
Assignee
Inventors
- Yaakov Greenberg (Even-Yehuda, IL)
- Shahar Harari (Tel Aviv, IL)
- Barry Salky (Snowmass Village, CO, US)
- Yaron Fuerst (Kfar-Vradim, IL)
Cpc classification
A61B17/1114
HUMAN NECESSITIES
A61B2017/2927
HUMAN NECESSITIES
International classification
A61B17/08
HUMAN NECESSITIES
A61B17/072
HUMAN NECESSITIES
A61B17/11
HUMAN NECESSITIES
Abstract
A device for laparoscopically approximating edges of a tissue opening toward each other for surgical attachment, the device including a first tissue engaging component, and a second tissue engaging component, a spreader component for moving the first tissue engaging component away from the second tissue engaging component, and a control for moving the first tissue engaging component away from the second tissue engaging component. Related apparatus and methods are also described.
Claims
1. A method for attaching opposing edges of an opening in a tissue to one another, the method comprising: using a first tissue engaging component to engage an opening in a tissue at a first location in said opening; using a second tissue engaging component to engage said opening at a second location in said opening; using a spreader component to move the first tissue engaging component away from the second tissue engaging component which causes opposing edges of said opening to be drawn closer together; and using a tissue attachment mechanism to attach portions of the tissue adjacent said opposing edges to one another, and wherein said first tissue engaging component and said second tissue engaging component are movably mounted on a common mounting element and said common mounting element is movable with respect to said tissue attachment mechanism.
2. The method according to claim 1, wherein using said tissue attachment mechanism to attach portions of the tissue adjacent said opposing edges to one another closes said opening.
3. The method according to claim 1, wherein said tissue attachment mechanism is used to attach portions of the tissue adjacent said opposing edges of said opening to one another by stapling them together.
4. The method according to claim 1, further comprising moving said tissue over a portion of said tissue attachment mechanism prior to using said tissue attachment mechanism to attach portions of the tissue to one another.
5. The method according to claim 1, further comprising cutting a part of the tissue.
6. The method according to claim 1, wherein the moving of said tissue over a portion of said tissue attachment mechanism prior to using said tissue attachment mechanism to attach portions of the tissue to one another comprises movement of said common mounting element, on which said first tissue engaging component and said second tissue engaging component are mounted, with respect to said tissue attachment mechanism.
7. The method according to claim 6, wherein said movement comprises rotating said common mounting element about a longitudinal axis of said tissue attachment mechanism.
8. The method according to claim 1, further comprising cutting tissue which is adjacent to said portions of the tissue that have been attached to one another.
9. The method according to claim 1, wherein the method is performed in a laparoscopic procedure.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
(1) Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
(2) In the drawings:
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DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION
(41) The present invention, in some embodiments thereof, relates to devices and methods for aligning tissue for surgical attachment and optionally surgically attaching the tissue and, more particularly, but not exclusively, to laparoscopic devices and methods for the above.
(42) Overview
(43) According to an aspect of some embodiments there is provided a device for aligning tissue for surgical attachment.
(44) In some embodiments the device is shaped to be inserted into an opening in tissue and to shape the opening, aligning edges of the tissue for surgically attaching to each other.
(45) In some embodiments a device is used to facilitate laparoscopic closure of, by way of a non-limiting example, two pieces of intestine intracorporeally with an improved (optionally TA-like) stapling device. The device is optionally designed to be able to engage a common enterotomy opening of a side-to-side, functional end-to-end gastrointestinal anastomosis, bring the engaged opening into jaws of a stapling instrument (or bring the jaws of a stapling instrument to the engaged opening), optionally by rotating the engaged opening into the device, optionally close the device, and fire 2 or 3 rows of staples thereby closing the enterotomy without need for sutures or need to re-sect any extra intestine. It is noted that re-secting extra intestine could lead to narrowing of the intestine.
(46) In some embodiments, the device includes two tissue engagement components which are inserted into the opening. In some embodiments, one or both of the tissue engagement components are prongs for engaging edges of the tissue opening. In some embodiments, one or both of the tissue engagement components are clamps for grabbing onto edges of the tissue opening.
(47) A non-grabbing engagement of tissue edges, such as by prongs or recesses in the device, produces a non-fixed engagement, enabling the tissue engagement components to slide along the tissue edges (or the tissue edges to slide along the tissue engagement components), while engaging, or maintain contact with, the tissue edges. A grabbing engagement of tissue edges, such as by a clamp, produces a fixed engagement, fixing the tissue engagement component to the tissue at the location being clamped, until the tissue engagement component is released.
(48) The term “tissue engagement” in all its grammatical forms is used throughout the present specification and claims to include both non-grabbing tissue engagement and grabbing tissue engagement.
(49) The words “drawing” tissue in all their grammatical forms are used throughout the present specification and claims interchangeably with the words “approximating” tissue and their corresponding grammatical forms.
(50) In some embodiments, the device includes two prongs which are inserted into the opening. In some embodiments, the device includes an elongate bent element with two recesses, each recess for catching an edge of the tissue opening. In some embodiments, the device includes an oval shape with two tips for catching edges of the tissue opening.
(51) In some embodiments the prongs are thin, shaped to pass through an opening of tissue which the prongs then optionally re-shape to a narrow opening which is to be stapled and/or sutured. The thickness of the prongs optionally comes between edges of the tissue opening even after the opening is re-shaped as the narrow opening, so the prongs are meant to be thin, so as not to cause the re-shaped tissue opening to be wide. In some embodiments the thickness of the prongs is in a range between 0.5 millimeters and 5 millimeters.
(52) By way of a contradicting example, surgical retractors are configured to stretch tissue apart, and tips of the retractors are shaped to contact/grab a substantial length of a tissue edge, for example 10, 20, 30 millimeters of tissue edge.
(53) In some embodiments, tips or prongs of the aligning device are shaped to contact tissue edge perpendicular to an axis along a length of the tips, that is approximately a diameter of the tips. In some embodiments a diameter of the prongs or tips is in a range of 0.5 millimeters to 5 millimeters.
(54) In some embodiments one prong is configured as a grabber, and grabs the tissue, while another prong is configured to slide along the edge of the tissue and also participate in shaping the tissue opening.
(55) In some embodiments two prongs are configured to be non-grabbing, so as to slide along the edge of the tissue.
(56) In some embodiments the two prongs are configured to move away from each other by force of an elastic actuator, by way of example by force of a spring.
(57) In some embodiments the force of the spring is in a range between 10 and 50 grams force, or 10 grams to 200 grams, to 2 kilograms, even to 5 kilograms force.
(58) In some embodiments the force of the spring is adjustable.
(59) In some embodiments the device includes a maintainer component to keep the prongs from expanding until the maintainer is released.
(60) In some embodiments the device is configured to stretch the tissue while aligning edges of the tissue. In some embodiments the device is configured to stretch the tissue by a specific amount, optionally by limiting an extent of movement of the tissue engagement components, such as the prongs, away from each other. In some embodiments the specific amount is measured by measuring a movement of a control for moving the tissue engagement components away from each other. In some embodiments the device is configured to stretch the tissue by a specific force, optionally by a spring with a specific force being used to stretch the tissue. In some embodiments the specific force is optionally measured by measuring a force acting upon the tissue engagement components.
(61) In some embodiments the device is configured to allow suturing the aligned edges of the tissue.
(62) In some embodiments the device is configured to align a tissue stapler appropriately along the aligned tissue edges.
(63) In some embodiments the device includes a shape which allows the tissue stapler to close upon tissue, and optionally staple tissue, at an appropriate distance from aligned edges of the tissue. The device optionally includes the tissue engagement components being located at an appropriate distance from the edge of the tissue stapler.
(64) In some embodiments the device includes a tissue stapler for optionally stapling the aligned edges of the tissue.
(65) In some embodiments the device is configured to be operated laparoscopically.
(66) In some embodiments the device is optionally configured so that the prongs are remotely operated, optionally by wire, optionally from outside a patient's body.
(67) In some embodiments the device is optionally configured so that an associated stapler is remotely operated, optionally by wire, optionally from outside a patient's body.
(68) According to an aspect of some embodiments there is provided a device for laparoscopically drawing edges of a tissue opening toward each other for surgical attachment.
(69) In some embodiments the device is shaped to be inserted into a keyhole incision, and extend to a tissue opening such as a hole or opening or slit in tissue inside a patient's body, and shape the hole/opening/slit, aligning edges of the tissue for surgically attaching to each other.
(70) In some embodiments, the device includes prongs for inserting into the tissue opening, and a spreader for optionally moving the prongs away from each other, to stretch the tissue opening into an elongated shape with tissue edges aligned parallel to each other.
(71) In some embodiments the device includes a first portion configured to operate the device from outside a patient's body, and a second portion configured to include the prongs and operate inside the patient's body.
(72) In some embodiments the device includes a spreader component for moving the prongs away from each other.
(73) In some embodiments the spreader component is configured to be operated from outside the patient's body.
(74) In some embodiments the spreader component includes a spring released by a control operated from outside the patient's body, the released spring moving the prongs away from each other.
(75) In some embodiments the spring is included in the first portion of the device, outside the patient's body.
(76) In some embodiments the spring is included in the second portion of the device, inside the patient's body.
(77) In some embodiments the prongs are connected to wires controlled from outside the patient's body. In some embodiments moving the prongs away from each other includes pushing and/or pulling the wires.
(78) In some embodiments the device includes a tissue stapler in the second portion of the device, configured to operate inside the patient's body.
(79) In some embodiments the prongs and/or the spreader device are configured to lie between jaws of a tissue stapler.
(80) In some embodiments the tissue stapler is configured to be operated from outside the patient's body.
(81) In some embodiments the device is shaped and sized to pass through a trocar, a catheter, an endoscope.
(82) In some embodiments the tissue stapler includes a blade for cutting excess tissue. In some embodiments the tissue stapler is a narrow tissue stapler without a blade.
(83) In some embodiments the tissue stapler is a narrow tissue stapler, comprising no more than 3 rows of staples. In some embodiments the tissue stapler is a narrow tissue stapler, comprising only 2 rows of staples. In some embodiments the tissue stapler is a narrow tissue stapler, comprising only 1 row of staples.
(84) According to an aspect of some embodiments there is provided a method for aligning tissue for surgical attachment, including inserting a device for aligning tissue for surgical attachment prongs into an opening in tissue, and moving the prongs away from each other, shaping the opening into an elongated opening causing edges of the tissue to move toward each other.
(85) In some embodiments, after the prongs have engaged the tissue and formed the tissue opening into an elongated opening form, the prongs are optionally additionally pulled in a directional perpendicular to the direction of the elongated opening, pulling parallel edges of the tissue to form parallel surfaces of tissue, for attachment to each other by suturing and/or stapling. In some embodiments, the tissue opening is sutured shut.
(86) In some embodiments, the tissue opening is stapled shut.
(87) In some embodiments, the first prong is moved away from the second prong by a spring which pushes the first prong away from the second prong.
(88) In some embodiments, a stapler is placed in contact with the first prong and the second prong in order to align the stapler for stapling the tissue.
(89) In some embodiments, the device includes specific rests or stops for aligning the stapler relative to the device.
(90) According to an aspect of some embodiments there is provided a method for laparoscopic surgical closure of an opening in tissue, including inserting a laparoscopic device for drawing edges of a tissue opening toward each other for surgical attachment through a keyhole incision in a patient's body, and using the device for drawing edges of a tissue opening toward each other.
(91) In some embodiments the laparoscopic device includes prongs as descried above, and the prongs are inserted into an opening in tissue, and moved away from each other to cause edges of the tissue to move toward each other.
(92) In some embodiments moving the prongs away from each other includes releasing a spring which pushes the prongs away from each other.
(93) In some embodiments a spring release control is manipulated outside a patient's body to release the spring.
(94) In some embodiments the tissue edges are sutured closed laparoscopically.
(95) In some embodiments a laparoscopic stapler is placed in contact with the tissue and the tissue is optionally stapled shut, and optionally edges of the tissue may be cut away.
(96) In some embodiments, the laparoscopic stapler is placed in contact with the device in order to align the stapler for stapling the tissue.
(97) In some embodiments, the device includes specific rests or stops for aligning the laparoscopic stapler relative to the device.
(98) In some embodiments the laparoscopic device includes a tissue stapler
(99) For purposes of better understanding some embodiments of the present invention, reference is first made to
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(101) It is noted that using the example illustration of an anastomosis procedure is not intended to limit scope of embodiments of the invention. Various embodiments which use methods and/or devices as described herein include: gastric anastomosis; small bowel anastomosis; colon anastomosis; closing a vaginal cuff in a vaginal hysterectomy; closing a uterine incision in a C-Section; and closure of a hysterotomy in a Caesarian Section.
(102) Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
(103) Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
(104) Reference is now made to
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(106) Reference is now made to
(107) The tissue retractor 113 has two loop prongs 112A 112B for inserting into a tissue opening. When the loop prongs 112A 112B are moved away from each other, sides of the tissue opening 114 are drawn apart. In an extreme case if the loop prongs 112A 112B are moved away from each other to a maximal distance, the tissue opening 114 forms a shape of a rectangle, with a width 115 corresponding to a width of the loop prongs 112A 112B and a length 116 of the tissue opening 114 making up the rest of the circumference of the tissue opening 114.
(108) Reference is now made to
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(110) In some embodiments, the prongs 117A 117B are optionally moved away from each other exerting some force, and edges of the tissue opening 118 are optionally stretched. In such cases the edges of the tissue opening are drawn closer together, potentially touching each other.
(111) In some embodiments, the prongs 117A 117B are optionally moved away from a line referenced as 121 in
(112) Reference is now made to
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(114) In some embodiments the example embodiment surgical procedure is an open stomach procedure. In some embodiments the example embodiment surgical procedure is a laparoscopic procedure, performed through one or more keyhole openings.
(115)
(116) In some embodiments the device 204 is shaped similarly to the Greek letter omega—Ω.
(117) In some embodiments the device 204 is made of a flexible material such as, by way of some non-limiting examples: st.st wire, Nitinol and plastic.
(118) In some embodiments a surgeon optionally approximates the two prongs 205A 205B together, optionally to a distance smaller than a Common Opening size, by way of a non-limiting example approximately 2 cm. In some embodiments the Common Opening size can be in a range of 10 millimeters to 10 centimeters in various embodiments the Common Opening length, and in some embodiments Common Opening diameter, can be in a range of 2 millimeters to 4 centimeters, and in some embodiments a tissue opening can be up to 30 centimeters. The surgeon optionally inserts the prongs 205A 205B into a hollow organ opening (Common Opening), and optionally releases the hooks. The device 204 springs back, optionally up to its original size, while stretching and aligning the Common Opening edges. The Common Opening is then ready for closure.
(119) In some embodiments the Common Opening starts as an amorphous shape and becomes 2-dimensional and therefore more convenient for closing by an external device like a surgical stapler, or by conventional suturing.
(120) In some embodiments stapler jaws are optionally placed at an appropriate location, not too far from the Common Opening edges. In some embodiments the device includes dedicated stoppers, in some embodiments part of the device wire, to indicate the stapler jaws location and/or locate the stapler jaws.
(121) In some embodiments a wire is shaped with specific curvature to enable free working space for suturing.
(122) In some embodiments the prongs can be part of the wire itself, optionally bent at an angle of 90 degrees or less. In some embodiments roughness is optionally added to a surface of the device and/or to the prongs to avoid slipping.
(123) In some embodiments the device 204 optionally includes a tweezers and/or pincer shape.
(124) In some embodiments the device 204 optionally includes one or more tissue graspers such as forceps.
(125) Reference is now additionally made to
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(127) The elongate shape of the tissue opening 203 is ready for attachment of edges of the tissue to each other.
(128) In some embodiments the attachment of the edges of the tissue opening 203 to each other is optionally by sutured to each other. In some embodiments the attachment of the edges of the tissue opening 203 to each other is optionally by using adhesive to attach the edges to each other. In some embodiments the attachment of the edges of the tissue opening 203 to each other is optionally by stapling to each other.
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(130) In some embodiments the device 204 includes rests or extensions 206A 206B for optional use in aligning the stapler 207 to the edges of the tissue opening 203.
(131) In some embodiments the device 204 is configured so that the tips of the prongs 206A 206B extend further than the alignment extensions 206A 206B by a specific distance. In some embodiments the specific distance is used to control a distance between a line of stapling and edges of the tissue opening 203. In some embodiments the specific distance is optionally in a range between 1 millimeter and 10 millimeters, a range between 1 millimeter and 100 millimeters, a range between 1 millimeters and 1000 millimeters.
(132) Reference is now additionally made to
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(135) A first line 232 is shown at a level of the two prongs 205A 205B.
(136) A second line 231 is shown at a level of the two alignment extensions 206A 206B.
(137) As described above, in some embodiments the first line 232 is optionally at a same level as the second line 231, in some embodiments the first line 232 is optionally above the level of the second line 231, in some embodiments the first line 232 is optionally below the level of the second line 231.
(138) In some embodiments the material of the two prongs 205A 205B is optionally processed to be smooth, so that the two prongs 205A 205B may slide along a tissue edge.
(139) In some embodiments the material of the two prongs 205A 205B is optionally roughened so that the two prongs 205A 205B may adhere to a tissue edge and refrain from sliding.
(140) The very tips 233A 233B of the two prongs 205A 205B are shown.
(141) In some embodiments the tips 233A 233B are optionally rounded, so as not to penetrate tissue.
(142) In some embodiments the tips 233A 233B are optionally sharp, so as to penetrate tissue.
(143) Reference is now made to
(144) The example method illustrated by
(145) In some embodiments the slit is an opening in tissue, not necessarily slit-shaped.
(146) In some embodiments, the first tissue engaging component and the second tissue engaging component are optionally pulled in a directional perpendicular to a direction of the elongated opening, thereby pulling edges of the tissue to form parallel surfaces of tissue, for surgical closure of the tissue opening.
(147) In some embodiments the first tissue engaging component and the second tissue engaging component are optionally moved toward the tissue edges, optionally locating an optional tissue stapler at a correct location for stapling the tissue edges closed.
(148) In some embodiments, moving the first tissue engaging component away from the second tissue engaging component is optionally done by releasing a spring which pushes the first tissue engaging component away from the second tissue engaging component.
(149) In some embodiments the tissue opening is sutured closed.
(150) In some embodiments excess tissue is cut away from a suturing line.
(151) In some embodiments a stapler is placed in contact with the first tissue engaging component and the second tissue engaging component.
(152) In some embodiments the stapler is placed in contact with stapler support locations on the first tissue engaging component and the second tissue engaging component.
(153) In some embodiments the tissue opening is stapled closed.
(154) In some embodiments the first tissue engaging component is configured as a first prong. In some embodiments the second tissue engaging component is configured as a second prong.
(155) In some embodiments the first tissue engaging component is configured as a first tissue grasper. In some embodiments the second tissue engaging component is configured as a second tissue grasper.
(156) Reference is now made to
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(158) In some embodiments the example embodiment surgical procedure is an open stomach procedure. In some embodiments the example embodiment surgical procedure is a laparoscopic procedure, performed through one or more keyhole openings.
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(160) Reference is now additionally made to
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(162) The elongate shape of the tissue opening 303 is ready for attachment of edges of the tissue to each other.
(163) In some embodiments the attachment of the edges of the tissue opening 303 to each other is optionally by sutured to each other. In some embodiments the attachment of the edges of the tissue opening 303 to each other is optionally by using adhesive to attach the edges to each other. In some embodiments the attachment of the edges of the tissue opening 303 to each other is optionally by stapling to each other.
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(165) In some embodiments the device is suitable for use in laparoscopic surgery. The device is optionally shaped and/or sized, and/or made flexible, to enable the device to be inserted through a laparoscopic delivery device. In some embodiments the device is optionally bent to fit within the laparoscopic delivery device.
(166) In some embodiments the device fits within a delivery device with a diameter of 5 mm. In some embodiments the device fits within a delivery device with a diameter in a range of 2 millimeters to 5, 10, 15, 20, 25 millimeters,
(167) In some embodiments the device is optionally pushed outside a cannula of a laparoscopic delivery device using an external pusher, and prongs of the device are optionally placed inside the Common Opening.
(168) In some embodiments, after closuring is performed, the device is pulled outside the body through a conventional trocar using a grasper.
(169) Reference is now made to
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(171) In some embodiments, the tissue engagement components 315A 315B are attached to the handle 312 by connecting components 313A 313B.
(172) In some embodiments the tissue engagement components 315A 315B may optionally be tissue graspers or clamps.
(173) When the tissue engagement components 315A 315B engage tissue and are moved away from each other, sides of the tissue opening are drawn together. The tissue opening is shaped into a shape of a narrow opening, with a length of the tissue opening of half a circumference of the tissue opening or longer, when the tissue edges are optionally stretched.
(174) In some embodiments, the tissue engagement components 315A 315B are optionally moved away from each other exerting some force, and edges of the tissue opening are optionally stretched.
(175) In some embodiments, the tissue engagement components 315A 315B are optionally moved away from the tissue, pulling on the tissue edges, and optionally causing the tissue edges to lie parallel to each other, ready for attaching to each other by suturing, stapling or use of adhesive.
(176) In some embodiments the tissue engaging components 315A 315B are optionally normally open. In some embodiments the tissue engaging components 315A 315B are optionally normally closed.
(177) In some embodiments, the device 311 further includes rests 316A 316B for optionally locating a tissue stapler at a desired location for stapling tissue edges closed.
(178) In some embodiments, the rests 316A 316B are part of the handle 312. In some embodiments the rests 316A 316B are optionally attached to the handle 312 by connectors, optionally adjustable connectors, such as the connectors 313A 313B shown in
(179) In some embodiments a bottom of the rests 316A 316B is optionally located at a same line as bottoms of the tissue engagement components 315A 315B so as to align the tissue stapler correctly.
(180) In some embodiments the bottom of the rests 316A 316B is optionally located above or below the line of the bottoms of the tissue engagement components 315A 315B so as to align the tissue stapler correctly.
(181) In some embodiments a location of the bottom of the rests 316A 316B is adjustable, in order to align the tissue stapler correctly.
(182) In some embodiments the handle 312 is flexible and/or springy.
(183) In some embodiments the handle 312 is made of wire.
(184) In some embodiments the handle 312 the handle includes a spring exerting force to pull the tissue engagement components 315A 315B away from each other. In some embodiment the spring (not shown in
(185) Reference is now made to
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(188) The device 404 of
(189) Reference is now made to
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(191) In some embodiments the drawing element which is named the trocar 415 is intended to portray a sheath 415. Where the description of
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(197) In some embodiments the device 414 is optionally attached to the device controller 416 by a connector 417.
(198) In some embodiments the connector 417 is optionally controllable to detach the device 414 from the device controller 416.
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(200) In some embodiments, if it is desired to pull the device 414 back through the trocar 415, the device controller 416 reattaches to the device 414. In some embodiments, if it is desired to pull the device 414 back through the trocar 415, a grasper (not shown) may optionally be inserted through the trocar, grasp the device 414, and pull the device 414 back through the trocar 415.
(201) Reference is now made to
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(203) The example device 500 includes: a component 515 for drawing edges of tissue opening toward each other for laparoscopic surgical closure; an optional hinge 518 for optionally changing an angle of the component 515 relative to a shaft 514; an optional control 513 for optionally moving tissue engagement components (not referenced in
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(205) In some embodiments the optional trigger 517 optionally closes a tissue stapler anvil and/or shoots staples, optionally when an optional safety 523 has been disengaged.
(206) Reference is now made to
(207) The example method illustrated by
(208) The above potentially causes edges of the tissue to move toward each other.
(209) In some embodiments the engaging a first tissue engaging component with tissue near a first end of a slit in tissue (504) is an engaging a first tissue engaging component with tissue at a first location in an opening in tissue, and the engaging a second tissue engaging component with tissue near a second end of the slit (506) is an engaging a second tissue engaging component with tissue at a second location in the opening.
(210) In some embodiments, the edges of the tissue are sutured shut.
(211) In some embodiments, the edges of the tissue are optionally pulled into an opening between a stapler and a stapler anvil.
(212) In some embodiments, a stapler and a stapler anvil are optionally moved toward the edges of the tissue, optionally on both sides of the edges of the tissue.
(213) In some embodiments, the edges of the tissue are stapled shut.
(214) Reference is now made to
(215) The example method illustrated by
(216) The above potentially causes edges of the tissue to move toward each other.
(217) In some embodiments the pushing a first tissue engaging component to engage with tissue near a first end of a slit in tissue (534) is pushing a first tissue engaging component to engage with tissue at a first location in the opening in tissue, and the pushing a second tissue engaging component away from the first tissue engaging component to engage with tissue near a second end of a slit in tissue (536) is a pushing a second tissue engaging component away from the first tissue engaging component to engage with tissue at a second location in the opening in tissue.
(218) In some embodiments, the edges of the tissue are sutured shut.
(219) In some embodiments, the edges of the tissue are optionally pulled into an opening between a stapler and a stapler anvil.
(220) In some embodiments, a stapler and a stapler anvil are optionally moved toward the edges of the tissue, optionally on both sides of the edges of the tissue.
(221) In some embodiments, the edges of the tissue are stapled shut.
(222) Reference is now made to
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(225) The example device 540 includes: a component 541 for drawing edges of tissue opening toward each other for laparoscopic surgical closure; an optional hinge 542 for optionally changing an angle of the component 541 relative to a shaft 543; an optional control 544 for optionally moving tissue engagement components (not referenced in
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(227) Reference is now made to
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(230) The component 541 optionally includes a wire, not shown, for controlling movement and/or rotation of the prongs 553A 553B from outside a patient's body.
(231) In some embodiments one or both of the two prongs 553A 553B may optionally be tissue graspers and not prongs.
(232) An example sequence of operation of the device 540 of
(233)
(234) In some embodiments the component 541 is optionally inserted into a patient's body, optionally through a trocar. In some embodiments the component 541 is optionally placed near an opening in tissue.
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(237) In some embodiments the device 540 includes a fail-safe mechanism, which prevents the two prongs 553A 553B from being moved to jut from the component 541 when the cover 550 is not open.
(238) In some embodiments the device 540 includes a fail-safe mechanism, which prevents closing the cover 550 when the two prongs 553A 553B are not completely inside the component 541.
(239) In some embodiments the device 540 includes a fail-safe mechanism, which prevents closing the cover 550 when the two prongs 553A 553B are not completely outside the component 541.
(240) In some embodiments the device 540 includes a fail-safe mechanism, which prevents closing the cover 550 when the two prongs 553A 553B are not completely inside the component 541 or completely outside the component 541.
(241) Reference is now made to
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(245) The component 566 optionally includes a wire, not shown, for controlling movement and/or rotation of the prongs 564A 564B from outside a patient's body.
(246) In some embodiments one or both of the two prongs 564A 564B may optionally be tissue graspers and not prongs.
(247) Reference is now made to
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(251) In some embodiments one or both of the two prongs 601A 601B may optionally be tissue graspers and not prongs.
(252) An example sequence of operation of the device 500 of
(253) A portion of the device 500 including the component 515 is inserted into a patient's body, optionally through a trocar.
(254) In some embodiments the component 515 has a maximum diameter in a range between 5 millimeters and 15 millimeters, so as to pass through a trocar.
(255) Reference is now additionally made to
(256)
(257)
(258) In some embodiments the component 515 includes a fail-safe mechanism, which prevents the prongs 601A 601B from being moved to jut from the component 515 when the cover/anvil 607 is not open.
(259) In some embodiments the component 515 includes a fail-safe mechanism, which prevents closing the cover/anvil 607 when the prongs 601A 601B are not completely inside the component 515.
(260) In some embodiments the component 515 includes a fail-safe mechanism, which prevents closing the cover/anvil 607 when the prongs 601A 601B are not completely outside the component 515.
(261) In some embodiments the component 515 includes a fail-safe mechanism, which prevents closing the cover/anvil 607 when the prongs 601A 601B are not completely inside the component 515 or completely outside the component 515.
(262) In some embodiments the component 515 includes a fail-safe mechanism, which prevents closing the cover/anvil 607 unless the bridge 603 is in a distal position, close to the tip 609 of the component 515.
(263) Reference is now additionally made to
(264)
(265)
(266) Reference is now additionally made to
(267)
(268) The prongs 601A 601B are shown inserted into the tissue opening 613.
(269) Reference is now additionally made to
(270)
(271) Reference is now additionally made to
(272)
(273)
(274) Reference is now additionally made to
(275)
(276)
(277)
(278) Reference is now additionally made to
(279)
(280)
(281)
(282) In some embodiments the cover/anvil 607 is opened, and the component 515 is optionally pulled away from the stapled tissue.
(283) In some embodiments the cover/anvil 607 is left closed, and an optional tissue cutter 625 optionally cuts the tissue along the stapled edge. After cutting the tissue the component 515 can optionally be pulled away from the stapled tissue.
(284) Reference is now additionally made to
(285)
(286)
(287)
(288) In some embodiments the cover/anvil 607 is opened, and the component 515 is optionally pulled away from the stapled tissue.
(289) In some embodiments the cover/anvil 607 is left closed, and the component 515 is optionally pulled away from the stapled tissue.
(290) Reference is now made to
(291)
(292)
(293) The component 700 optionally includes a wire, not shown, for controlling movement and/or rotation of the prongs 703A 703B from outside a patient's body;
(294) In some embodiments one or both of the two prongs 701A 701B may optionally be tissue graspers and not prongs.
(295) An example sequence of operation of the device 700 of
(296)
(297) In some embodiments the component 700 is optionally inserted into a patient's body, optionally through a trocar. In some embodiments the component 700 is optionally placed near an opening in tissue.
(298)
(299)
(300) Reference is now additionally made to
(301) An optional continuation of the example sequence of operation of the device 700 shown in
(302)
(303)
(304)
(305)
(306)
(307)
(308)
(309)
(310) Example embodiments will now be shown where prongs will jut out using a parallelogram design, and causing edges of tissue being pulled by a parallelogram design.
(311) Reference is now made to
(312)
(313)
(314) In some embodiments one or both of the two prongs 803A 803B may optionally be tissue graspers and not prongs.
(315) In some embodiments the component 800 optionally includes a spring (not shown) for moving the prongs 803A 803B away from each other.
(316) An example sequence of operation of the device 800 of
(317)
(318) In some embodiments the component 800 is optionally inserted into a patient's body, optionally through a trocar. In some embodiments the component 800 is optionally placed near an opening in tissue.
(319)
(320)
(321) At this point the two prongs 803A 803B are optionally inserted into an opening in tissue, optionally catching edges of the opening in tissue.
(322)
(323)
(324)
(325) Reference is now made to
(326)
(327)
(328) The component 900 can optionally be shifted from one side to another by pushing/pulling a rod 911 connected to the component 900 by a hinge 912.
(329)
(330) In some embodiments the flexible shaft 906 is optionally a hollow flexible shaft, to enable a wire going through (the wire is not shown).
(331) Referring again to
(332) In some embodiment a push/pull wire (not shown) goes through the hollow flexible shaft in order to slide and/or rotate the bridge 603 of
(333) In some embodiments more than one control wire and/or flex shaft 906 are optionally used.
(334) Detachable Shaft
(335) Reference is now made to
(336)
(337) The device 1000 is optionally configured so a distal portion 1007B of a shaft of the device 1000 may optionally be detached from a proximal portion 1007A of the device 1000.
(338) In some embodiments the proximal portion 1007A of the device 1000 includes controls for operating the distal portion 1002 of the device 1000.
(339) In some embodiments the distal portion 1007B of the device 1000 is optionally replaceable or even disposable.
(340)
(341)
(342)
(343)
(344) The device 1000 shown in
(345) In some embodiments the component 1015 optionally includes one or more of: a mechanism for drawing edges of tissue opening toward each other, a stapler, a tissue cutter, an optional hinge. In some embodiments the optional controls 1010 1013 1016 1017 1021 1023 operate one or more of the mechanism for drawing edges of a tissue opening toward each other, the stapler, the tissue cutter, and the hinge.
(346) Add-on Device
(347) Reference is now made to
(348)
(349)
(350)
(351) In some embodiments, the add-on device 1100 optionally includes one or more of: two prongs 1109 1110 for drawing edges of a tissue opening toward each other; a prong support 1108 for supporting the prongs 1109 1110, along which one or more of the prongs 1109 1110 can slide, and which in some embodiments can rotate the prongs 1109 1110 around a shaft 1112; an optional connector 1111 between the prong support 1108 and the shaft 1112; a sleeve 1104 for mounting the add-on device 1100 to the shaft 1112; a first control 1105 for optionally providing the rotational movement to the shaft 1112; a second control 1106 for optionally moving the prongs 1109 1110 toward or away from each other; and a wire 1107 or rod 1107 for transferring movement from the second control 1106 to the prongs 1109 1110, optionally along the shaft 1112.
(352) In some embodiments the sleeve 1104 completely surrounds the shaft 1101 of the stapler 1102.
(353) In some embodiments the sleeve 1104 surrounds a partial circumference of the shaft 1101 of the stapler 1102. In some embodiments an extent of the partial surrounding is in a range of angles from somewhat more than 180 degrees, for example 185 degrees; up to somewhat less than 360 degrees, for example 359 degrees. In some embodiments the partial-circumference sleeve 1104 is flexible, and can be stretched to open the along the lengthwise opening so as to slip sideways over the shaft 1101 of the stapler 1102.
(354) In some embodiments the sleeve 1104 optionally serves for transferring rotational movement to the shaft 1112.
(355) In some embodiments the sleeve 1104 optionally serves for transferring translational movement to the shaft 1112.
(356)
(357) In some embodiments the first control 1105 optionally serves to rotate the shaft 1112, optionally causing the prongs 1109 1110 to jut out of a diameter of the stapler 1102 or fold into the stapler 1102.
(358) In some embodiments the second control 1106 optionally serves to push or pull the wire 1107 or rod 1107, optionally causing the prongs 1109 1110 to move away from or toward each other.
(359)
(360)
(361)
(362) In some embodiments the stapler 1102 optionally includes a cartridge 1116 of staples. In some embodiments the cartridge 1116 is optionally narrower than a width of the stapler 1102, leaving a space 1118 for components of the add-on 1100, such as, by way of some non-limiting examples, the prongs 1109 1110 and/or the prong support 1108. In some embodiments the space 1118 potentially enables rolling the prongs 1109 1110 and/or the prong support 1108 into the stapler 1102, so that the stapler 1102 does not become wider, and can pass through a trocar, similarly to a stapler without the add-on.
(363)
(364)
(365)
(366)
(367) In some embodiments the space 1120 optionally serves for accepting a standard stapler cartridge therein. In some embodiments the standard stapler cartridge optionally includes 4 rows of staples. In some embodiments the standard stapler cartridge optionally includes N rows of staples.
(368) In some embodiments the space 1120 optionally serves for accepting a modified stapler cartridge therein, which leaves a space such as the space 1118 shown in
(369) Some features of example embodiments of an add-on device as described herein include:
(370) Providing features of capturing tissue opening edges and/or drawing tissue opening edges toward each other and/or stapling tissue and/or tissue cutting, all in a single tool/device; embodiments of the add-on device can be made to fit existing tissue staplers and existing laparoscopic tissue staplers; embodiments of the add-on device allow use of standard staple cartridges, and some embodiments include specially customized staple cartridges converting a laparoscopic tissue stapler to a laparoscopic tissue stapler with enhanced capabilities including one or more of capturing tissue opening edges and/or drawing tissue opening edges toward each other and/or tissue cutting, all in a single tool/device; providing easy tissue capture capabilities using prongs or tissue capture mechanism; providing easy tissue alignment capabilities; providing external controls for one or more of tissue capture, tissue alignment; tissue stapling, tissue cutting; and the above-mentioned enhanced capability laparoscopic tissue stapler is sized to pass through a trocar.
(371) In some embodiments the add-on device enlarges a stapler diameter by a specific amount, by way of some non-limiting examples, by 1, 2, 3, 4, 5 millimeters, or otherwise phrased, by an amount in a range of 1-5 millimeters or more.
(372) In some embodiments the enhanced capability laparoscopic tissue stapler can pass through a trocar with a 15 mm diameter.
(373) In some embodiments the add-on device enlarges a stapler diameter so that, by way of some non-limiting examples, the enhanced capability laparoscopic tissue stapler with a stapler diameter of 12 mm passes through a 15 mm trocar, a stapler diameter of 10 mm passes through 12 mm trocar, a stapler diameter of 8 mm passes through a 10 mm trocar.
(374) Reference is now made to
(375) The method of
(376) In some embodiments, the add-on device includes: a first tissue engaging component configured to engage an opening in tissue near a first location in the opening; a second tissue engaging component configured to engage the opening near a second location in the opening; a spreader component configured to move the first tissue engaging component away from the second tissue engaging component; a control for moving the first tissue engaging component away from the second tissue engaging component, the control configured to be external to a patient's body.
(377) Two Tools
(378) Reference is now made to
(379)
(380)
(381) In some embodiments the first tool 1202 includes a tissue stapler 1206, a shaft 1208, and a handle 1210. In some embodiments the handle 1210 includes controls for operating the tissue stapler. In some embodiments the first tool 1202 includes a tissue cutter, and the controls also operate the tissue cutter.
(382)
(383)
(384)
(385)
(386) In some embodiments the first tool 1202 is a standard tissue stapler.
(387) In some embodiments the first tool 1202 is a modified tissue stapler, modified to engage with the second tool 1204.
(388)
(389)
(390)
(391) In some embodiments the optional interface 1226 of the second tool 1204 is optionally cone shaped, as shown in
(392) In some embodiments the first control 1216 is a control which controls movement of the prongs 1222 1224 toward each other or away from each other, potentially in order to capture tissue opening edges and/or drawing tissue opening edges toward each other.
(393) Some features of example embodiments of a two-tool system as described herein include: providing separate controls for capturing tissue opening edges and separate for tissue stapling; providing a physician separate control of location and/or attitude of the tissue aligner and the tissue stapler; each one of the may pass through a trocar of only 12 mm in diameter; each one of the first tool 1204 and the second tool 1202 may pass through a trocar of only 12 mm in diameter; and the first tool 1204 for capture tissue opening edges and/or drawing tissue opening edges toward each other can pass through a trocar of only 5 mm in diameter, or larger, for example in a range of 4 mm to 12 mm.
(394) Reference is now made to
(395)
(396)
(397)
(398) In some embodiments the component 1212 is inserted into a patient's body with the prongs 1222 1224 folded.
(399) In some embodiments the component 1212 with the prongs 1222 1224 folded can pass through a small diameter trocar, as small as 2-5 millimeters in diameter.
(400) In some embodiments the prongs 1222 1224 are optionally constructed of shape memory material, with their unfolded shape being the shape which the material forms when released.
(401) In some embodiments the prongs 1222 1224 are optionally folded into the component 1212, and the component 1212 is optionally inserted through a trocar or even a catheter. When a section of the component 1212 is extruded from the trocar or catheter, the shape memory material of the prongs 1222 1224 optionally causes the prongs 1222 1224 to just out from the component 1212, as shown in
(402) Prongs on Anvil
(403) In some embodiments, prongs for capturing tissue-opening edges and/or drawing tissue-opening edges toward each other are optionally placed on an anvil side of a tissue stapler device.
(404) Reference is now made to
(405)
(406)
(407) In some embodiments the handle 1210 includes controls for operating the tissue stapler 1302. In some embodiments the tissue stapler 1302 includes a tissue cutter, and the controls also operate the tissue cutter.
(408)
(409) In some embodiments the controls also operate the prongs 1312 1314. In some embodiments the controls operate the prongs 1312 1314 by wire, so as to transfer control, or movement, through an angle of an open jaw of the tissue stapler 1302.
(410) Some features of example embodiments of a device with the tissue capture capability on a tissue stapler anvil include: providing features of capturing tissue opening edges and/or drawing tissue opening edges toward each other and/or stapling tissue and/or tissue cutting, all in a single tool/device; providing controls for the above functionality in one device; and the device may pass through a trocar of only 12 mm in diameter.
(411) Controls
(412)
(413) The number of controls optionally ranges, by way of some non-limiting examples, from one control, to two controls, to three controls, to four controls, to five controls.
(414) It is expected that during the life of a patent maturing from this application many relevant tissue attachment devices such as sutures, staples, and adhesives will be developed and the scope of the term tissue attachment device is intended to include all such new technologies a priori.
(415) As used herein the term “about” refers to ±25%.
(416) The terms “comprising”, “including”, “having” and their conjugates mean “including but not limited to”.
(417) The term “consisting of” is intended to mean “including and limited to”.
(418) The term “consisting essentially of” means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
(419) As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a unit” or “at least one unit” may include a plurality of units, including combinations thereof.
(420) The words “example” and “exemplary” are used herein to mean “serving as an example, instance or illustration”. Any embodiment described as an “example” or “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments.
(421) The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the invention may include a plurality of “optional” features unless such features conflict.
(422) Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
(423) Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.
(424) As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
(425) As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.
(426) It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.
(427) Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
(428) All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.