WO2020193303A1 - Skin foundation access portal - Google Patents

Skin foundation access portal Download PDF

Info

Publication number
WO2020193303A1
WO2020193303A1 PCT/EP2020/057404 EP2020057404W WO2020193303A1 WO 2020193303 A1 WO2020193303 A1 WO 2020193303A1 EP 2020057404 W EP2020057404 W EP 2020057404W WO 2020193303 A1 WO2020193303 A1 WO 2020193303A1
Authority
WO
WIPO (PCT)
Prior art keywords
pad
surgical access
access device
port
surgical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2020/057404
Other languages
English (en)
French (fr)
Inventor
J. Riley Hawkins
Christopher Ramsay
Thomas Gamache
Eric Buehlmann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medos International SARL
Original Assignee
Medos International SARL
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medos International SARL filed Critical Medos International SARL
Priority to EP20713237.4A priority Critical patent/EP3941370A1/en
Priority to AU2020247333A priority patent/AU2020247333A1/en
Priority to CN202080023251.5A priority patent/CN113613572B/zh
Priority to JP2021556773A priority patent/JP7500599B2/ja
Publication of WO2020193303A1 publication Critical patent/WO2020193303A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
    • A61B17/0218—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/50—Supports for surgical instruments, e.g. articulated arms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3407—Needle locating or guiding means using mechanical guide means including a base for support on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B2017/3443—Cannulas with means for adjusting the length of a cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

  • a surgical access device such as, for example, a port
  • the connecting mechanism can include an arm coupled at a first end to the surgical access device and coupled at a second end to the pad. Further, in some embodiments, the arm can be bendable to adjust placement of the first end relative to the second end.
  • selectively locking the position of the surgical access device can prevent further translation, rotation, or angulation of the surgical access device with respect to the pad.
  • FIG. 5 is a perspective view of the foundation pad of FIG. 1 ;
  • FIG. 20 is a perspective view of the surgical access stabilization device of FIG. 1 with a surgical access device disposed therein;
  • FIG. 30 is a representation of an exemplary surgical application of another embodiment of a surgical access stabilization device
  • FIG. 34 is a representation of an exemplary foundation pad of the surgical access stabilization device of FIG. 33;
  • FIG. 37 is a representation of another exemplary surgical application of the surgical access stabilization device of FIG. 35;
  • FIG. 41 is an exploded view of the handle of FIG. 40.
  • FIGS. 1-4 illustrate a first exemplary embodiment of a surgical access stabilization device 100.
  • the device 100 can be used to stabilize a surgical access device, e.g., a port or access device 10, inserted through an incision in a patient.
  • a surgical access stabilization device of the present invention can be patient-mounted to stabilize a surgical access device with respect to the patient.
  • the device 100 can selectively restrict any one of
  • FIG. 2 shows the surgical access stabilization device of FIG. 1 without a surgical access device disposed therein.
  • a central opening 101 can extend through the surgical access stabilization device 100 and can be configured to receive the port 10. As shown in FIG. 2, in some embodiments, the central opening 101 can extend through the locking mechanism 104 and the pad 102.
  • a central axis A1 of the surgical access stabilization device can extend through the central opening 101 normal to the proximal surface of the pad.
  • the port 10 can be inserted distally along the axis A1 through the central opening 101 such that the port 10 is received within the surgical access stabilization device.
  • FIG. 3 illustrates a cross-sectional view of FIG.
  • an outer surface of the port 10 can have a plurality of longitudinally aligned grooves 18.
  • the port extension portion 16 of the handle 12 can have at least one inwardly extending protrusion configured to selectively engage with at least one of the grooves 18 of port 10.
  • the handle by way of adjusting the engagement between the port extension portion and the plurality of grooves 18, can be placed at a desired position on port 10.
  • a grip 14 can be used to move the port 10 with respect to the pad 102 and the axis Al in any of a rotational, angular, or translational direction.
  • the proximal end of port 1 Op can be directly manipulated, without attaching a handle thereto, to facilitate movement of the port.
  • the skirt 204 can have an extension 320 extending proximally from the surface 318 to define the opening 316.
  • an inner surface 324 of the extension 320 defining the opening 316 can preferably be a smooth surface, tapered from a proximal end of the opening to a distal end of the opening.
  • a smooth tapered surface 324 can facilitate rotational and angular movement of a split ring 206, and a surgical access device received therein, relative to the skirt 204.
  • the extension 320 can include an engagement feature configured to engage with another portion of the locking mechanism 104, and preferably with a locking piece of the locking mechanism 104.
  • the engagement feature can be external threads 322 formed on an outer surface of extension 320.
  • Other means for engaging the skirt 204 to a locking piece of the locking mechanism 104 are also considered within the scope of the invention.
  • the split ring 206 can have one or more engagement features configured to aid in a selective longitudinal positioning of a surgical access device 10 received in the opening 416.
  • at least one inwardly projecting protrusion 408 can be formed on the inner surface 404 to engage with complementary features formed on an outer surface of a surgical access device, such as a plurality of grooves 18.
  • Engagement of the split ring engagement features and complementary features formed on an outer surface of the surgical access device can provide for easier alignment and longitudinal adjustment of the surgical access device relative to the inner ring.
  • Engaging engagement features of the split ring 206 with an inserted surgical access device can provide a secure connection between the two components, such that the split ring 206 can move in accordance with application of a force to the surgical access device.
  • complementary engagement features of a split ring and a surgical access device can provide beneficial tactile feedback to a user regarding alignment and engagement of a surgical access device with the inner ring.
  • the laterally extending portion 510 can be raised a distance from a distal end of the proximally extending portion 508 such that the cavity 212 is formed beneath the laterally extending portion 510 from an inner radial point of the main body 500 radially outward to an inner facing surface of the proximally extending portion 506.
  • the main body 500 can have a solid wall circumference, i.e. proximally extending portion 508, and an overhang, i.e. laterally extending portion 510, which does not extend a full distal length of the solid wall circumference but rather creates a radial gap at a distal portion of the retaining ring 202.
  • the radially extending protrusions 502 extend radially outward from the rim 504 and can be configured to engage with the groove 225 of the base 200. Inserting the retaining ring 202 within the base 200 can comprise aligning the radially extending protrusions 502 with the recessed sections 228 of the base 200 such that the protrusions 502 are aligned with the groove 225. Once inserted, the retaining ring 202 can be secured within the base 200 by rotating the retaining ring such that a leading edge 518 of a radially extending protrusion 502 abuts an edge of a transition 226 of the base 200.
  • FIG. 19 is a cross sectional top view of FIG. 18, showing the retaining ring 202 engaged with the base 200 and rotated such that the protrusions 502 align with the extension sections 224. In this locked position, the leading edge 518 of each protrusion 502 can be seen abutting a transition 226 of the base 200.
  • the cavity 212 configured to slidably receive the skirt 204, can be seen between an inner surface of the laterally extending portion 510 and the base 200.
  • FIG. 20 shows the surgical access stabilization device 100 with a locking mechanism 104 having a first locking piece 208 and a second locking piece 210.
  • the locking mechanism 104 can include a first and a second locking piece to selectively lock a position of a surgical access device with respect to a foundation pad.
  • the first and second locking pieces, e.g., 208 and 210 can be locking rings. In other words,
  • the locking mechanism 104 can include, for example, at least one releasable adhesive site, a threaded locking knob, or a lever action tightening wheel. It will be appreciated that any of the locking components disclosed herein are contemplated for use alone or in combination to selectively lock motion of a surgical access device relative to a pad.
  • the first locking piece 208 can be a locking ring configured to engage with the retaining ring 202 to selectively lock translation movement of an inserted surgical access device, such as port 10.
  • the second locking piece 210 can be a locking ring configured to engage with the skirt 204 to selectively lock rotational, angular, and translational movement of a surgical access device, such as port 10, inserted within the split ring 206.
  • the first locking piece can be generally ring shaped having a wall 602 and an opening 608.
  • An outer diameter of the first locking piece can preferably be substantially the same or slightly smaller than an inner diameter of the retaining ring 202.
  • An outer surface of the wall 602 can have an engagement feature 604, configured to engage with a complementary engagement feature of the retaining ring 202.
  • the engagement feature can be threads 604 formed on the outer surface of wall the 602.
  • a tab 606 can extend radially from an upper portion of the wall 602 to aid in rotating or otherwise moving first locking piece 208.
  • the tab 606 can be sized and shaped to facilitate a user grip of the tab 606 and rotation of the first locking piece 208.
  • FIG. 23 shows an exemplary embodiment of the second locking piece 210 configured as a locking ring formed by the wall 702 with a central opening 706.
  • An outer surface of the wall 702 can be shaped to have a curved lower portion and a tapered upper portion.
  • the wall 702 can have a radially inward extending upper portion 708 that forms a hood over an inner surface 704 of the second locking piece 210.
  • the opening 706 can be defined at a proximal end by an inner surface of the upper portion 708 and by the inner surface 704 at a distal end. In this manner, the opening 706 can have a first diameter at the proximal end that is smaller than a second diameter of the opening 706 at the distal end.
  • the second locking piece 210 when the second locking piece 210 is rotated in the second direction, the second locking piece moves proximally relative to the skirt, thereby reducing any inward compressive forces applied by the second locking piece on the skirt 204.
  • the second locking piece when a surgical access device is received within the opening formed by the skirt 204, the second locking piece can selectively restrict movement between the surgical access device and the skirt by selectively applying and removing an inward compressive force on the skirt extension 320. As can been seen from FIG.
  • an adhesive distal facing side of the pad 102 can be placed at a desired location on the skin of a patient.
  • the base 200 can be moved distally onto pad 102, and can be secured to the pad 102 by engaging complementary engagement features of the base and the pad.
  • slots 209 of the base 200 can be aligned with protrusions 110 of the pad 102.
  • the base can then be secured to the pad 102 with a snap fit.
  • the incision 120 can be made either before or after the pad 102 is secured to the anchor surface. Additionally, the incision 120 can be dilated to accommodate a variety of instruments either or before or after the pad 102 has been secured to the engagement surface, and either before or after the base 200 has been attached to the pad 102. Once an incision has been dilated to accommodate a surgical access device, such as a port 10, the port can be inserted through the incision. Again, insertion of the surgical access device can occur either before or after the pad 102 has been secured to the engagement surface, and can occur either before or after the base 200 or any other components of the locking mechanism 104 have been attached.
  • a surgical access device such as a port 10
  • FIG. 32 shows yet another exemplary embodiment of a surgical stabilization device 1030 of the present invention.
  • Surgical access stabilization device 1030 includes a pad 1032 configured as a full patch having a generally rectangular shape.
  • a locking mechanism 1034 is shown at a central location of pad 1032.
  • locking mechanism 1034 can be received at any location on pad 1032.
  • Pad 1032 can include navigational markings such as markings 1036 to aid in alignment and placing of pad 1032 relative to surgical or anatomical structures.
  • Pad 1 102 can have an opening 1106 configured to receive a surgical access device.
  • opening 1106 can be an elongate slot extending along pad 1102.
  • pad 1102 can have an opening 1106 extending along a longitudinal axis of the pad.
  • pad 1102 can be generally rectangular in shape.
  • opening 1 106 can have a similar or complementary shape to that of pad 1 102.
  • opening 1106 can have a different shape than that of pad 1102.
  • the pad 1102 and opening 1 106 can have any of a variety of shapes.
  • Arm 1206 can be made of a malleable material such that the arm can be bent to adjust positioning of the first end relative to the second end. In this manner, a surgical access device connected to the first end of the arm can be placed in a desired position relative to a pad coupled to the second end of the arm by bending the arm to a desired configuration.
  • connector 1208 can be located on the first end of arm 1206 to engage with an attachment piece 1214 to couple the port 1210 to the first end of the arm.
  • Connector 1208 can engage attachment piece 1214 by any means of connecting as is known in the art.
  • connector 1208 can be a ball joint connector and can receive an extension of attachment piece 1214 within a recess of the ball joint connector to secure attachment piece 1214 to arm 1206.
  • the handle 1600 can include a locking portion 1650 that can engage with features of a surgical access device to selectively maintain relative positioning between the surgical access device and the handle 1600.
  • the locking portion 1650 can be a zip-tie or ratchet/pawl style snapping lever having one or more teeth 1652 that can engage with features on an outer surface of a surgical access device.
  • the one or more teeth 1652 of the locking portion 1650 can selectively engage with one or more grooves formed on an outer surface of a surgical access device when the surgical access device is disposed within a through hole 1640.
  • the locking portion 1650 can include a tab or lever biased to engage with a surgical access device without user interaction.
  • FIG. 41 shows the lever 1630 of FIG. 40 separated from the main body 1610.
  • the lever 1630 can selectively engage the locking portion 1650 to move the locking portion out of engagement with a surgical access device within the through hole 1640 of the handle 1600, thereby acting as a release to allow adjustment of a surgical access device relative to the handle.
  • the lever 1630 can be a generally planar element with at least one engagement feature extending from a distal facing surface thereof.
  • a first post 1632 can extend from a distal facing surface of a first planar portion 1636 and can be received within a slot 1612 in the main body 1610.
  • a user can engage the lever such that the lever moves the locking portion 1650 to selectively engage a surgical access device disposed in the through hole 1640.
  • a force can be applied to the lever 1630 such that the first post 1632 translates within the slot 1612.
  • the second post 1634 of the lever can remain fixed within the hole 1614 of the main body, such that the lever can pivot about the second post as the first post 1632 translates within the slot 1612 in the main body 1610.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Surgical Instruments (AREA)
PCT/EP2020/057404 2019-03-22 2020-03-18 Skin foundation access portal Ceased WO2020193303A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP20713237.4A EP3941370A1 (en) 2019-03-22 2020-03-18 Skin foundation access portal
AU2020247333A AU2020247333A1 (en) 2019-03-22 2020-03-18 Skin foundation access portal
CN202080023251.5A CN113613572B (zh) 2019-03-22 2020-03-18 皮肤基底入口
JP2021556773A JP7500599B2 (ja) 2019-03-22 2020-03-18 皮膚の基礎アクセスポータル

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US16/362,488 US11241252B2 (en) 2019-03-22 2019-03-22 Skin foundation access portal
US16/362,488 2019-03-22

Publications (1)

Publication Number Publication Date
WO2020193303A1 true WO2020193303A1 (en) 2020-10-01

Family

ID=69941356

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2020/057404 Ceased WO2020193303A1 (en) 2019-03-22 2020-03-18 Skin foundation access portal

Country Status (6)

Country Link
US (2) US11241252B2 (https=)
EP (1) EP3941370A1 (https=)
JP (1) JP7500599B2 (https=)
CN (1) CN113613572B (https=)
AU (1) AU2020247333A1 (https=)
WO (1) WO2020193303A1 (https=)

Cited By (1)

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CN113545829A (zh) * 2021-06-22 2021-10-26 田洪森 一种多腔道内窥镜微创手术装置

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US11241252B2 (en) 2019-03-22 2022-02-08 Medos International Sarl Skin foundation access portal
US20220304750A1 (en) * 2021-03-25 2022-09-29 Shaw P. Wan Imaging needle guide
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