US20150351852A1 - Tool member cover and cover deployment device - Google Patents
Tool member cover and cover deployment device Download PDFInfo
- Publication number
- US20150351852A1 US20150351852A1 US14/831,971 US201514831971A US2015351852A1 US 20150351852 A1 US20150351852 A1 US 20150351852A1 US 201514831971 A US201514831971 A US 201514831971A US 2015351852 A1 US2015351852 A1 US 2015351852A1
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- United States
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- cover
- deployment device
- sleeve
- distal end
- tool member
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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
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
-
- A61B19/12—
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
- A61B17/3431—Cannulas being collapsible, e.g. made of thin flexible material
-
- A61B19/40—
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B46/00—Surgical drapes
- A61B46/10—Surgical drapes specially adapted for instruments, e.g. microscopes
- A61B46/13—Surgical drapes specially adapted for instruments, e.g. microscopes the drapes entering the patient's body
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B46/00—Surgical drapes
- A61B46/20—Surgical drapes specially adapted for patients
- A61B46/27—Surgical drapes specially adapted for patients tubular, e.g. for arms or legs
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- 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
- A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
- A61B17/1155—Circular staplers comprising a plurality of staples
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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
- A61B17/34—Trocars; Puncturing needles
- A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
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- A61B19/081—
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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
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00287—Bags for minimally invasive surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61B2017/3435—Cannulas using everted sleeves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
- A61B2050/314—Flexible bags or pouches
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- 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
- A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
- A61B2090/0409—Specification of type of protection measures
- A61B2090/0427—Prevention of contact
-
- A—HUMAN NECESSITIES
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- A61B46/00—Surgical drapes
- A61B46/10—Surgical drapes specially adapted for instruments, e.g. microscopes
Definitions
- This application relates to a cover and cover deployment device for the tool member or tool assembly of a surgical instrument, and more particularly, to a cover and cover deployment device for the tool member of a laparoscopic or endoscopic surgical instrument for manipulating, treating or excising tissue, especially diseased or cancerous tissue, from a body cavity.
- surgical instruments A variety of different types of surgical instruments have been developed for manipulating, identifying, treating, repairing and/or excising tissue including organs or portions thereof located within body cavities such instruments sometimes being hereafter referred to as surgical instruments for treatment of body tissues.
- These instruments include graspers, fasteners, e.g., staplers, dissectors, biopsy devices, coagulators, etc.
- fasteners e.g., staplers, dissectors, biopsy devices, coagulators, etc.
- these instruments are dimensioned to be used in both open and laparoscopic or endoscopic procedures.
- a surgical instrument In endoscopic surgical procedures for treatment of body tissue, a surgical instrument is inserted through an incision or cannula to a position adjacent the tissue to be treated. The distal tool member of the instrument is then manipulated to treat, i.e., biopsy, excise, dissect, coagulate, reposition, etc., the tissue. Thereafter, the instrument with or without excised tissue is withdrawn from the surgical site through the incision to remove the instrument from the body cavity.
- the tool member or tool assembly (hereafter, for simplicity “tool member”) of the surgical instrument for treating, for example, diseased, tissue comes into contact with the healthy tissue defining the incision and/or within the body cavity in which the surgical site is located.
- the healthy tissue defining the incision and/or within the body cavity in which the surgical site is located.
- This may also be a problem in open surgical procedures. Where the tissue being treated is diseased tissue, e.g., cancerous, this problem becomes critical since contact between the cancerous tissue and the healthy tissue may result in seeding of cancerous cells resulting in metastases.
- the present disclosure provides a tool member cover for use with a surgical instrument having a tool assembly and a body portion.
- the cover is preferably tubular and has open distal and proximal ends. A portion of the cover, preferably the distal end, is fastened to the surgical instrument adjacent to or on the tool assembly. Alternately, the cover may be removably attached to the surgical instrument. The cover is movable from a first position in which the tool member is uncovered to a second position in which the cover at least partially encompasses the tool member.
- the cover is formed of an impermeable material.
- a deployment device is provided for moving the cover from the first position to the second position.
- the deployment device includes a sleeve formed of half-sections which are held together using expandable members, e.g., resilient O-rings.
- the O-rings allow the sleeve half-sections to move outwardly relative to each other to allow the sleeve to pass over a tool assembly having a larger diameter than a body portion of the surgical instrument.
- the sleeve is slidably positioned about the body of a surgical instrument between retracted and advanced positions to move the cover from the first position to the second position.
- the cover is positioned about the body portion of the surgical instrument and about the deployment device such that when the deployment device is moved from the retracted to the advanced position, the distal end of the sleeve engages the distal end of the cover to invert the cover over the tool assembly.
- the cover may include a closure device such as a drawstring or elastic band to close the distal end of the cover to enclose the tool member within the cover.
- a closure device such as a drawstring or elastic band to close the distal end of the cover to enclose the tool member within the cover.
- the cover may be used with a variety of different types of surgical instruments including staplers, fasteners, manipulators, biopsy devices, retractors, coagulators, dissectors etc.
- FIG. 1 is a perspective view of one preferred embodiment of the presently disclosed tool member cover and cover deployment device, with parts separated, positioned about an unapproximated circular surgical stapler;
- FIG. 2 is a side perspective view of the deployment device sleeve with parts separated of the deployment device shown in FIG. 1 ;
- FIG. 3 is a side perspective view of the deployment device sleeve shown in FIG. 2 ;
- FIG. 4 is a perspective cutaway view of the distal end of the deployment device sleeve shown in FIG. 3 fastened together with an O-ring;
- FIG. 5 is a perspective view of the deployment device shown in FIG. 3 positioned about the body portion of an unapproximated circular surgical stapler with the sleeve halves in an expanded configuration;
- FIG. 6 is a side perspective view of the deployment device of FIG. 5 in a contracted configuration, shown positioned about the body portion of an unapproximated circular surgical stapler;
- FIG. 7 is a side perspective view of the tool member cover and cover deployment device of FIG. 1 positioned about the body portion of an unapproximated circular surgical stapler with the cover and deployment device in a retracted position and the deployment device in a contracted configuration;
- FIG. 8 is a side perspective view of the tool member cover and cover deployment device of FIG. 7 positioned about the body portion of an approximated circular surgical stapler with the cover and deployment device in a retracted position and the deployment device in a contracted configuration;
- FIG. 9 is a side perspective view of the tool member cover and cover deployment device of FIG. 7 positioned about the body portion and tool assembly of a circular surgical stapler with the cover and deployment device in a partially advanced position and the deployment device in an expanded configuration;
- FIG. 10 is a side perspective cutaway view of the tool member cover deployed about the tool member of an approximated circular surgical stapler
- FIG. 11 is a side perspective view of another preferred embodiment of the presently disclosed cover deployment device.
- FIG. 12 is a side perspective view with portions broken away of the cover deployment device shown in FIG. 11 supported on a body portion of an unapproximated circular surgical stapler;
- FIG. 13 is a side perspective view with portions broken away of the tool member cover and cover deployment device shown in FIG. 12 supported on a body portion of an unapproximated circular surgical stapler with the deployment device and cover in retracted positions;
- FIG. 14 is a side perspective view of the cover deployment device shown in FIG. 1 positioned about the body portion of endoscopic gastrointestinal anastomosis linear stapler;
- FIG. 15 is a side perspective view with portions broken away of another preferred embodiment of the tool member cover and the cover deployment device shown in FIG. 1 positioned about the body portion of the endoscopic gastrointestinal anastomosis linear stapler of FIG. 15 and with the cover and deployment device in retracted positions;
- FIG. 16 is a side perspective view of the tool member cover in a deployed configuration positioned about the tool member of the endoscopic gastrointestinal intestinal anastomosis linear stapler of FIG. 15 ;
- FIG. 17 is a side perspective view of the cover deployment device shown in FIG. 1 positioned about the body portion of an ultrasonic dissection device;
- FIG. 18 is a side perspective view of the tool member cover and cover deployment device shown in FIG. 1 positioned about the body portion of the ultrasonic dissection device of FIG. 17 with the tool member cover and deployment device in retracted positions;
- FIG. 19 is a side perspective view of the tool member cover in a deployed configuration about the tool member of the ultrasonic dissection device of FIG. 18 .
- FIG. 1 illustrates one preferred embodiment of the presently disclosed tool member cover and cover deployment device.
- tool member cover 10 includes a collapsible flexible material which is preferably liquid impermeable and formed from one or more layers of a suitable plastic, preferably, polyethylene. Alternately, other liquid impermeable materials, woven or non-woven, natural or synthetic, and suitable for surgical use may be used to construct the cover, e.g., rubber, elastomers, polytetrafluroethylene, etc.
- Cover 10 is preferably tubular and defines a lumen 12 dimensioned or configured to receive the body portion 58 of a surgical instrument 11 .
- the distal end 10 a of cover 10 has a smaller diameter than the proximal end of cover 10 .
- a portion of cover 10 is preferably fastened to the surgical instrument.
- the distal end 10 a of cover 10 is dimensioned or configured to be fastened directly onto or adjacent to a tool member 52 or a shaft that adjoins a tool member or a handle of a surgical instrument 11 .
- cover 10 may have a constant diameter along its entire length or the proximal end of cover 10 may have a smaller diameter than the distal end of cover 10 .
- Cover 10 is preferably fastened to the surgical instrument in a liquid impermeable manner. Cover 10 may also be removably attached to the surgical instrument.
- cover deployment device 14 ( FIG. 5 ) includes a sleeve 16 formed of sleeve half-sections 16 a and 16 b.
- Sleeve half-section 16 a includes a pair of extensions 18 which are dimensioned to be slidably received within slots 20 formed in sleeve 16 b.
- Each sleeve half-section 16 a and 16 b includes a proximal end 22 having a flange or semi-annular ring 24 , a centrally positioned semi-annular recess 25 , a distally positioned semi-annular recess 26 and a proximally positioned semi-annular recess 27 .
- the distal end 28 of each sleeve 16 a and 16 b includes a semi-annular blunt protrusion 30 . The function of protrusion 30 will be discussed in detail hereinbelow.
- sleeve half-sections 16 a and 16 b are positioned in abutting relationship, with extensions 18 slidably positioned in slots 20 to define a lumen 32 dimensioned to slidably receive or be positioned about a portion of the body of surgical instrument 11 .
- An expandable member preferably resilient O-ring 34 ( FIG. 1 ) is positioned in each of annular recesses 25 , 26 and 27 .
- O-rings 34 are stretchable from a contracted position to an expanded position to allow sleeve half-sections 16 a and 16 b to move in relation to each other between contracted and expanded positions ( FIGS. 3 , 4 and 9 , respectively). In the contracted position, sleeves 16 a and 16 b are preferably held in abutting relation with extensions 18 fully inserted within slots 20 .
- sleeve half-sections 16 a and 16 b are configured to be easily assembled about the elongated body portion 58 of surgical instrument 11 such that the distal end 28 of sleeve 16 is positioned adjacent a tool assembly 52 of surgical instrument 11 .
- surgical instrument 11 is illustrated as a circular stapler, it is envisioned that the surgical instrument may be any of a wide variety of instruments for performing a wide variety of functions including cutting, fastening, manipulating, treating, dissecting, coagulating and biopsing tissue.
- Such instruments include retractors, biopsy devices, dissectors, coagulators, fasteners, staplers, including linear staplers, circular stapler, semi-circular staplers, arc shaped staplers, etc.
- circular stapler 11 includes an unapproximated tool assembly 52 having an anvil 54 , a shell assembly 56 and an elongated body 58 .
- One known circular stapler is disclosed in PCT application Serial No. PCT/US02/10792, which is incorporated herein in its entirety by reference.
- Sleeve 16 is expandably and slidably positioned about elongated body 58 such that protrusion 30 is positioned adjacent to shell assembly 56 .
- the distal end 10 a of cover 10 is preferably secured adjacent to or on the proximal portion of tool assembly 52 at a fastening point or securement 60 ( FIG.
- cover 10 may be releaseably secured to the instrument using known techniques including springs, tabs, hooks, etc.
- Annular protrusion 30 which is formed at the distal end 28 of sleeve 16 , is positioned proximally of fastening point or securement 60 .
- cover 10 can be secured at any suitable location along shaft 58 , although on some instruments securing it close to or even on the tool member itself will save cover material and will render the cover easier to manipulate with or without tissue therein.
- the distal end 10 a of cover 10 is fastened to the proximal portion of shell assembly 56 of tool assembly 52 .
- surgical instrument 11 is positioned such that tool assembly 52 is located adjacent the surgical site. During an endoscopic surgical procedure, this would include inserting the tool assembly 52 and a portion of body portion 58 through an incision with cover 10 and cover deployment device 14 supported about elongated body portion 58 of surgical instrument 11 . Thereafter, the surgical instrument is manipulated to perform its associated or designed function. With respect to a circular stapler, body tissue (not shown) is positioned between an unapproximated anvil 54 and shell assembly 56 using, for example, a purse string suture (not shown).
- annular ring 24 of sleeve 16 is pushed forward manually, mechanically, remotely, or robotically in the direction indicated by arrows “A” in FIG. 9 to advance sleeve 16 about body 58 of surgical instrument 11 .
- annular protrusion 30 engages distal end 10 a to invert cover 10 about securement 60 and gradually about cover 10 proximally of secured or attached tool assembly 52 .
- Annular protrusion 30 includes a smooth or blunt surface to prevent tearing of cover 10 during advancement. Because tool assembly 52 has a diameter larger than body 58 , at least the distal end portions of sleeve half-sections 16 a and 16 b expand outwardly in relation to each other by stretching O-rings 34 as distal end 28 of sleeve 16 rides over tool assembly 58 . It is noted that in surgical instruments having a tool assembly having a diameter equal to or less than the diameter of the body of the surgical instrument, stretchable o-rings would not be required. When sleeve 16 has been advanced to fully deploy cover 10 about and preferably beyond tool assembly 52 ( FIG.
- the cover deployment device can be withdrawn to its retracted position about body 58 of surgical instrument 11 .
- Surgical instrument 11 including tool assembly 52 and incised tissue therein or thereabout (not shown) and enclosed by cover 10 can now be withdrawn from the surgical site without exposing the healthy tissue defining the incision and within the body cavity (not shown) to diseased tissue on or in the tool assembly.
- FIGS. 11-13 illustrate another preferred embodiment of the presently disclosed cover deployment device shown generally as 116 .
- Cover deployment device 116 includes a semi-rigid body portion 122 having a proximal semi-annular guide portion 124 and a distal semi-annular engagement member 126 .
- Semi-annular engagement member 126 is preferably formed of a sufficiently, diametrically and radially resilient material and is configured and dimensioned to engage the proximal end of a tool assembly 152 of a surgical instrument 111 .
- Proximal guide portion 124 is configured to partially encompass body portion 158 of surgical instrument 111 and to be pushed by a surgeon to operate deployment device 116 .
- Body portion 122 of deployment device 116 interconnects guide portion 124 and engagement member 126 and is sufficiently rigid to transfer the imparted pushing force to the engagement member 126 .
- the distal end 110 a of cover 110 is secured to surgical instrument 111 adjacent to or on a proximal portion of tool assembly 152 in the manner described above with respect to cover 10 , such that cover 110 is positioned about deployment device 116 and body 158 of surgical instrument 111 .
- Engagement member 126 is positioned slightly proximally of a fastening point 160 of cover 110 and to tool assembly 152 .
- deployment device 116 is advanced about body 158 of surgical instrument 111 by pushing on guide portion 124 to advance engagement member 126 into the distal end of cover 110 to invert cover 110 about tool assembly 152 in a manner similar to that disclosed above. Because engagement member 126 is flexible, it is able to slide over the increasing diameter of tool assembly 152 . After cover 110 is fully deployed (not shown), deployment device 116 can be retracted and surgical instrument 111 can be removed from a surgical site.
- distal end 110 a of cover 110 can be secured to tool assembly 152 or a similar or like operating end to end anastomosis device that does not require holes such as “H” ( FIG. 12 ) to vent directly to the atmosphere.
- FIGS. 14-16 illustrate another preferred embodiment of tool assembly cover 210 and cover deployment device 214 including sleeve 216 positioned about a body portion 258 of an endoscopic gastrointestinal anastomosis linear stapler 211 .
- a stapler is described in detail in U.S. Pat. No. 6,241,139 which issued on Jun. 5, 2001 and is incorporated herein in its entirety by reference.
- the cover deployment device 216 is substantially identical in structure and use as the deployment device described in FIGS. 1-10 and will not be described in further detail herein.
- Cover 210 is substantially identical to cover 10 described above but further includes an elastic band 226 formed about, within or integrally with a central portion of cover 210 .
- Cover 210 is deployed in a manner substantially identical to that disclosed above.
- elastic band 226 when elastic band 226 is forced over the distal end of tool assembly 252 of surgical instrument 211 , elastic band 226 contracts to close cover 210 about tool assembly 252 .
- the enclosed bag prevents tissue and/or body fluids from escaping cover 210 and infecting healthy tissue in the body cavity or in the incision.
- one or more elastic band(s) 226 may be employed with or incorporated into any of the covers disclosed herein.
- FIG. 17-19 illustrate tool assembly cover 10 and cover deployment device 14 shown in FIGS. 1-6 positioned about body 358 of an ultrasonic dissector instrument 311 .
- an ultrasonic dissector instrument 311 is disclosed in U.S. Pat. No. 6,024,750 which issued on Feb. 14, 2000 and is incorporated herein in its entirety by reference.
- cover 10 is preferably fastened to the distal end of elongated body 358 of instrument 311 proximally of a tool assembly 352 of instrument 311 such that when cover 10 is deployed, in the manner discussed above with respect to FIGS. 1-6 , tool assembly 352 and/or contaminated or treated tissue is encompassed by cover 10 ( FIG. 19 ).
- a closure device other than an elastic band may be provided to close the cover about the tool assembly.
- a drawstring “D” FIG. 10
- the cover need not be inverted about the tool assembly but rather may be slid directly over the tool assembly.
- the cover may be configured to not only encompass the tool assembly but may also be configured to encompass a distal portion or the entire body portion of the surgical instrument. Accordingly, modifications such as those suggested above, but not limited thereto, are to be considered within the scope of the invention.
Abstract
A surgical instrument including a tool member cover and a cover deployment device are disclosed. The cover is supported adjacent to or on the tool assembly of the surgical instrument and is movable from a first position in which the tool assembly is uncovered to a second position in which the tool assembly is at least partially encompassed by the cover. The deployment device is provided for moving the cover from the first position to the second position.
Description
- This application is a continuation of U.S. application Ser. No. 10/522,914 filed Jan. 28, 2005, which is a 371 of application No. PCT/US03/24201 filed Jul. 31, 2003, which claims the benefit of and priority to U.S. Provisional Application Ser. No. 60/400,328, filed Jul. 31, 2002, the entire contents of which are incorporated herein by reference.
- 1. Technical Field
- This application relates to a cover and cover deployment device for the tool member or tool assembly of a surgical instrument, and more particularly, to a cover and cover deployment device for the tool member of a laparoscopic or endoscopic surgical instrument for manipulating, treating or excising tissue, especially diseased or cancerous tissue, from a body cavity.
- 2. Background of Related Art
- A variety of different types of surgical instruments have been developed for manipulating, identifying, treating, repairing and/or excising tissue including organs or portions thereof located within body cavities such instruments sometimes being hereafter referred to as surgical instruments for treatment of body tissues. These instruments include graspers, fasteners, e.g., staplers, dissectors, biopsy devices, coagulators, etc. Typically, these instruments are dimensioned to be used in both open and laparoscopic or endoscopic procedures.
- In endoscopic surgical procedures for treatment of body tissue, a surgical instrument is inserted through an incision or cannula to a position adjacent the tissue to be treated. The distal tool member of the instrument is then manipulated to treat, i.e., biopsy, excise, dissect, coagulate, reposition, etc., the tissue. Thereafter, the instrument with or without excised tissue is withdrawn from the surgical site through the incision to remove the instrument from the body cavity.
- One problem associated with current surgical devices is that during removal of the tool member from the surgical site, the tool member or tool assembly (hereafter, for simplicity “tool member”) of the surgical instrument for treating, for example, diseased, tissue comes into contact with the healthy tissue defining the incision and/or within the body cavity in which the surgical site is located. This may also be a problem in open surgical procedures. Where the tissue being treated is diseased tissue, e.g., cancerous, this problem becomes critical since contact between the cancerous tissue and the healthy tissue may result in seeding of cancerous cells resulting in metastases.
- Accordingly, a need exists in the art for improved instrumentation for shielding healthy tissue from diseased tissue during removal of a surgical instrument from a surgical site.
- The present disclosure provides a tool member cover for use with a surgical instrument having a tool assembly and a body portion. The cover is preferably tubular and has open distal and proximal ends. A portion of the cover, preferably the distal end, is fastened to the surgical instrument adjacent to or on the tool assembly. Alternately, the cover may be removably attached to the surgical instrument. The cover is movable from a first position in which the tool member is uncovered to a second position in which the cover at least partially encompasses the tool member.
- Preferably, the cover is formed of an impermeable material. A deployment device is provided for moving the cover from the first position to the second position. In a first embodiment, the deployment device includes a sleeve formed of half-sections which are held together using expandable members, e.g., resilient O-rings. The O-rings allow the sleeve half-sections to move outwardly relative to each other to allow the sleeve to pass over a tool assembly having a larger diameter than a body portion of the surgical instrument. The sleeve is slidably positioned about the body of a surgical instrument between retracted and advanced positions to move the cover from the first position to the second position. The cover is positioned about the body portion of the surgical instrument and about the deployment device such that when the deployment device is moved from the retracted to the advanced position, the distal end of the sleeve engages the distal end of the cover to invert the cover over the tool assembly.
- The cover may include a closure device such as a drawstring or elastic band to close the distal end of the cover to enclose the tool member within the cover. The cover may be used with a variety of different types of surgical instruments including staplers, fasteners, manipulators, biopsy devices, retractors, coagulators, dissectors etc.
- Various preferred embodiments of the presently disclosed tool member cover and cover deployment device are described herein with reference to the drawings, wherein:
-
FIG. 1 is a perspective view of one preferred embodiment of the presently disclosed tool member cover and cover deployment device, with parts separated, positioned about an unapproximated circular surgical stapler; -
FIG. 2 is a side perspective view of the deployment device sleeve with parts separated of the deployment device shown inFIG. 1 ; -
FIG. 3 is a side perspective view of the deployment device sleeve shown inFIG. 2 ; -
FIG. 4 is a perspective cutaway view of the distal end of the deployment device sleeve shown inFIG. 3 fastened together with an O-ring; -
FIG. 5 is a perspective view of the deployment device shown inFIG. 3 positioned about the body portion of an unapproximated circular surgical stapler with the sleeve halves in an expanded configuration; -
FIG. 6 is a side perspective view of the deployment device ofFIG. 5 in a contracted configuration, shown positioned about the body portion of an unapproximated circular surgical stapler; -
FIG. 7 is a side perspective view of the tool member cover and cover deployment device ofFIG. 1 positioned about the body portion of an unapproximated circular surgical stapler with the cover and deployment device in a retracted position and the deployment device in a contracted configuration; -
FIG. 8 is a side perspective view of the tool member cover and cover deployment device ofFIG. 7 positioned about the body portion of an approximated circular surgical stapler with the cover and deployment device in a retracted position and the deployment device in a contracted configuration; -
FIG. 9 is a side perspective view of the tool member cover and cover deployment device ofFIG. 7 positioned about the body portion and tool assembly of a circular surgical stapler with the cover and deployment device in a partially advanced position and the deployment device in an expanded configuration; -
FIG. 10 is a side perspective cutaway view of the tool member cover deployed about the tool member of an approximated circular surgical stapler; -
FIG. 11 is a side perspective view of another preferred embodiment of the presently disclosed cover deployment device; -
FIG. 12 is a side perspective view with portions broken away of the cover deployment device shown inFIG. 11 supported on a body portion of an unapproximated circular surgical stapler; -
FIG. 13 is a side perspective view with portions broken away of the tool member cover and cover deployment device shown inFIG. 12 supported on a body portion of an unapproximated circular surgical stapler with the deployment device and cover in retracted positions; -
FIG. 14 is a side perspective view of the cover deployment device shown inFIG. 1 positioned about the body portion of endoscopic gastrointestinal anastomosis linear stapler; -
FIG. 15 is a side perspective view with portions broken away of another preferred embodiment of the tool member cover and the cover deployment device shown inFIG. 1 positioned about the body portion of the endoscopic gastrointestinal anastomosis linear stapler ofFIG. 15 and with the cover and deployment device in retracted positions; -
FIG. 16 is a side perspective view of the tool member cover in a deployed configuration positioned about the tool member of the endoscopic gastrointestinal intestinal anastomosis linear stapler ofFIG. 15 ; -
FIG. 17 is a side perspective view of the cover deployment device shown inFIG. 1 positioned about the body portion of an ultrasonic dissection device; -
FIG. 18 is a side perspective view of the tool member cover and cover deployment device shown inFIG. 1 positioned about the body portion of the ultrasonic dissection device ofFIG. 17 with the tool member cover and deployment device in retracted positions; and -
FIG. 19 is a side perspective view of the tool member cover in a deployed configuration about the tool member of the ultrasonic dissection device ofFIG. 18 . - Preferred embodiments of the presently disclosed tool member cover and cover deployment device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views.
-
FIG. 1 illustrates one preferred embodiment of the presently disclosed tool member cover and cover deployment device. Briefly,tool member cover 10 includes a collapsible flexible material which is preferably liquid impermeable and formed from one or more layers of a suitable plastic, preferably, polyethylene. Alternately, other liquid impermeable materials, woven or non-woven, natural or synthetic, and suitable for surgical use may be used to construct the cover, e.g., rubber, elastomers, polytetrafluroethylene, etc.Cover 10 is preferably tubular and defines alumen 12 dimensioned or configured to receive thebody portion 58 of asurgical instrument 11. Preferably, but not necessarily, thedistal end 10 a ofcover 10 has a smaller diameter than the proximal end ofcover 10. A portion ofcover 10 is preferably fastened to the surgical instrument. Thedistal end 10 a ofcover 10 is dimensioned or configured to be fastened directly onto or adjacent to atool member 52 or a shaft that adjoins a tool member or a handle of asurgical instrument 11. Alternately, cover 10 may have a constant diameter along its entire length or the proximal end ofcover 10 may have a smaller diameter than the distal end ofcover 10.Cover 10 is preferably fastened to the surgical instrument in a liquid impermeable manner.Cover 10 may also be removably attached to the surgical instrument. - Referring also to
FIGS. 2-4 , cover deployment device 14 (FIG. 5 ) includes asleeve 16 formed of sleeve half-sections section 16 a includes a pair ofextensions 18 which are dimensioned to be slidably received withinslots 20 formed insleeve 16 b. Each sleeve half-section proximal end 22 having a flange orsemi-annular ring 24, a centrally positionedsemi-annular recess 25, a distally positionedsemi-annular recess 26 and a proximally positionedsemi-annular recess 27. Thedistal end 28 of eachsleeve blunt protrusion 30. The function ofprotrusion 30 will be discussed in detail hereinbelow. - Referring to
FIGS. 2-4 , sleeve half-sections extensions 18 slidably positioned inslots 20 to define alumen 32 dimensioned to slidably receive or be positioned about a portion of the body ofsurgical instrument 11. An expandable member, preferably resilient O-ring 34 (FIG. 1 ), is positioned in each ofannular recesses rings 34 are stretchable from a contracted position to an expanded position to allow sleeve half-sections FIGS. 3 , 4 and 9, respectively). In the contracted position,sleeves extensions 18 fully inserted withinslots 20. - Referring to
FIG. 5 , sleeve half-sections elongated body portion 58 ofsurgical instrument 11 such that thedistal end 28 ofsleeve 16 is positioned adjacent atool assembly 52 ofsurgical instrument 11. Althoughsurgical instrument 11 is illustrated as a circular stapler, it is envisioned that the surgical instrument may be any of a wide variety of instruments for performing a wide variety of functions including cutting, fastening, manipulating, treating, dissecting, coagulating and biopsing tissue. Such instruments include retractors, biopsy devices, dissectors, coagulators, fasteners, staplers, including linear staplers, circular stapler, semi-circular staplers, arc shaped staplers, etc. - Referring also to
FIGS. 6 and 7 , in the illustrated embodiment,circular stapler 11 includes anunapproximated tool assembly 52 having ananvil 54, ashell assembly 56 and anelongated body 58. One known circular stapler is disclosed in PCT application Serial No. PCT/US02/10792, which is incorporated herein in its entirety by reference.Sleeve 16 is expandably and slidably positioned aboutelongated body 58 such thatprotrusion 30 is positioned adjacent to shellassembly 56. Thedistal end 10 a ofcover 10 is preferably secured adjacent to or on the proximal portion oftool assembly 52 at a fastening point or securement 60 (FIG. 7 ) using a known fastening technique, e.g., adhesion, fusion, crimping, pins, clips etc. and is positioned aboutsleeve 16 andbody portion 58 ofsurgical instrument 11. Alternately, cover 10 may be releaseably secured to the instrument using known techniques including springs, tabs, hooks, etc.Annular protrusion 30, which is formed at thedistal end 28 ofsleeve 16, is positioned proximally of fastening point orsecurement 60. - It is understood that cover 10 can be secured at any suitable location along
shaft 58, although on some instruments securing it close to or even on the tool member itself will save cover material and will render the cover easier to manipulate with or without tissue therein. - Referring to
FIGS. 8-10 , in the illustrated embodiment, thedistal end 10 a ofcover 10 is fastened to the proximal portion ofshell assembly 56 oftool assembly 52. In use,surgical instrument 11 is positioned such thattool assembly 52 is located adjacent the surgical site. During an endoscopic surgical procedure, this would include inserting thetool assembly 52 and a portion ofbody portion 58 through an incision withcover 10 and coverdeployment device 14 supported aboutelongated body portion 58 ofsurgical instrument 11. Thereafter, the surgical instrument is manipulated to perform its associated or designed function. With respect to a circular stapler, body tissue (not shown) is positioned between anunapproximated anvil 54 andshell assembly 56 using, for example, a purse string suture (not shown). Next, theanvil 54 andshell assembly 56 are approximated andsurgical instrument 11 is fired in a known manner to dissect tissue and apply a circular array of staples to the dissected and remaining tissue. Aftersurgical instrument 11 has performed its associated function but prior to removal oftool assembly 52 from the surgical site,annular ring 24 ofsleeve 16 is pushed forward manually, mechanically, remotely, or robotically in the direction indicated by arrows “A” inFIG. 9 to advancesleeve 16 aboutbody 58 ofsurgical instrument 11. Assleeve 16 is advanced,annular protrusion 30 engagesdistal end 10 a to invertcover 10 aboutsecurement 60 and gradually aboutcover 10 proximally of secured or attachedtool assembly 52.Annular protrusion 30 includes a smooth or blunt surface to prevent tearing ofcover 10 during advancement. Becausetool assembly 52 has a diameter larger thanbody 58, at least the distal end portions of sleeve half-sections rings 34 asdistal end 28 ofsleeve 16 rides overtool assembly 58. It is noted that in surgical instruments having a tool assembly having a diameter equal to or less than the diameter of the body of the surgical instrument, stretchable o-rings would not be required. Whensleeve 16 has been advanced to fully deploycover 10 about and preferably beyond tool assembly 52 (FIG. 10 ), the cover deployment device can be withdrawn to its retracted position aboutbody 58 ofsurgical instrument 11.Surgical instrument 11 includingtool assembly 52 and incised tissue therein or thereabout (not shown) and enclosed bycover 10 can now be withdrawn from the surgical site without exposing the healthy tissue defining the incision and within the body cavity (not shown) to diseased tissue on or in the tool assembly. -
FIGS. 11-13 illustrate another preferred embodiment of the presently disclosed cover deployment device shown generally as 116. It is noted that the deployment devices disclosed herein are only exemplary embodiments. Any suitable deployment device capable of positioning a cover over a tool assembly of a surgical instrument after it has been used in a surgical procedure is within the scope of this disclosure.Cover deployment device 116 includes asemi-rigid body portion 122 having a proximalsemi-annular guide portion 124 and a distalsemi-annular engagement member 126.Semi-annular engagement member 126 is preferably formed of a sufficiently, diametrically and radially resilient material and is configured and dimensioned to engage the proximal end of atool assembly 152 of asurgical instrument 111.Proximal guide portion 124 is configured to partially encompassbody portion 158 ofsurgical instrument 111 and to be pushed by a surgeon to operatedeployment device 116.Body portion 122 ofdeployment device 116 interconnects guideportion 124 andengagement member 126 and is sufficiently rigid to transfer the imparted pushing force to theengagement member 126. - The
distal end 110 a ofcover 110 is secured tosurgical instrument 111 adjacent to or on a proximal portion oftool assembly 152 in the manner described above with respect to cover 10, such thatcover 110 is positioned aboutdeployment device 116 andbody 158 ofsurgical instrument 111.Engagement member 126 is positioned slightly proximally of afastening point 160 ofcover 110 and totool assembly 152. In use,deployment device 116 is advanced aboutbody 158 ofsurgical instrument 111 by pushing onguide portion 124 to advanceengagement member 126 into the distal end ofcover 110 to invertcover 110 abouttool assembly 152 in a manner similar to that disclosed above. Becauseengagement member 126 is flexible, it is able to slide over the increasing diameter oftool assembly 152. Aftercover 110 is fully deployed (not shown),deployment device 116 can be retracted andsurgical instrument 111 can be removed from a surgical site. - It is to be noted that the
distal end 110 a ofcover 110 can be secured totool assembly 152 or a similar or like operating end to end anastomosis device that does not require holes such as “H” (FIG. 12 ) to vent directly to the atmosphere. -
FIGS. 14-16 illustrate another preferred embodiment oftool assembly cover 210 and coverdeployment device 214 includingsleeve 216 positioned about abody portion 258 of an endoscopic gastrointestinal anastomosislinear stapler 211. Such a stapler is described in detail in U.S. Pat. No. 6,241,139 which issued on Jun. 5, 2001 and is incorporated herein in its entirety by reference. Thecover deployment device 216 is substantially identical in structure and use as the deployment device described inFIGS. 1-10 and will not be described in further detail herein. Cover 210 is substantially identical to cover 10 described above but further includes anelastic band 226 formed about, within or integrally with a central portion ofcover 210. Cover 210 is deployed in a manner substantially identical to that disclosed above. However, as shown inFIG. 16 , whenelastic band 226 is forced over the distal end oftool assembly 252 ofsurgical instrument 211,elastic band 226 contracts to closecover 210 abouttool assembly 252. The enclosed bag prevents tissue and/or body fluids from escapingcover 210 and infecting healthy tissue in the body cavity or in the incision. It is noted that one or more elastic band(s) 226 may be employed with or incorporated into any of the covers disclosed herein. -
FIG. 17-19 illustratetool assembly cover 10 and coverdeployment device 14 shown inFIGS. 1-6 positioned aboutbody 358 of anultrasonic dissector instrument 311. Such an instrument is disclosed in U.S. Pat. No. 6,024,750 which issued on Feb. 14, 2000 and is incorporated herein in its entirety by reference. As illustrated, cover 10 is preferably fastened to the distal end ofelongated body 358 ofinstrument 311 proximally of atool assembly 352 ofinstrument 311 such that whencover 10 is deployed, in the manner discussed above with respect toFIGS. 1-6 ,tool assembly 352 and/or contaminated or treated tissue is encompassed by cover 10 (FIG. 19 ). - While the invention has been particularly shown and described with reference to the preferred embodiments, it will be understood by those skilled in the art that various modifications and changes in form and detail may be made therein without departing from the scope and spirit of the invention. For example, a closure device other than an elastic band may be provided to close the cover about the tool assembly. For example, a drawstring “D” (
FIG. 10 ) may be provided which can be grasped at the surgical site using graspers to close thecover 10 or the drawstring may be fed through the surgical instrument and be accessible from the proximal portion of the surgical instrument. Further, the cover need not be inverted about the tool assembly but rather may be slid directly over the tool assembly. Also, the cover may be configured to not only encompass the tool assembly but may also be configured to encompass a distal portion or the entire body portion of the surgical instrument. Accordingly, modifications such as those suggested above, but not limited thereto, are to be considered within the scope of the invention.
Claims (21)
1-15. (canceled)
16. A cover deployment device comprising:
a sleeve having a distal end and a proximal end and defining a lumen, the sleeve including a first sleeve half-section and a second sleeve half-section that are movable in relation to each other between a contracted position and an expanded position; and
at least one expandable member positioned about the sleeve to urge the first and second sleeve half-sections towards the contracted position.
17. The cover deployment device of claim 16 , wherein the at least one expandable member includes a first expandable member positioned about the distal end of the sleeve and a second expandable member positioned about the proximal end of the sleeve.
18. The cover deployment device of claim 16 , wherein the at least one expandable member is a resilient O-ring.
19. The cover deployment device of claim 16 , wherein the sleeve includes a proximally located annular ring.
20. The cover deployment device of claim 16 , wherein the first sleeve half-section includes at least one projection and the second sleeve half-section includes at least one slot, the at least one projection being slidable into the at least one slot to maintain alignment between the first and second half-sections when the first and second half-sections are moved between the contracted and expanded positions.
21. The cover deployment device of claim 20 , wherein the at least one projection includes two projections and the at least one slot includes two slots.
22. The cover deployment device of claim 16 , wherein the sleeve defines at least one annular recess, the at least one annular recess being configured to receive the at least one expandable member.
23. The cover deployment device of claim 22 , wherein the at least one annular recess includes a first annular recess positioned about the distal end of the sleeve and a second annular recess positioned about the proximal end of the sleeve, each of the first and second annular recesses being configured to receive one of the at least one expandable members.
24. The cover deployment device of claim 16 , wherein the distal end of the sleeve includes an annular protrusion.
25. The cover deployment device of claim 24 , wherein the annular protrusion is blunt.
26. A tool member cover and cover deployment device assembly comprising:
the cover deployment device of claim 1; and
a hollow cover having a proximal end and a distal end, the distal end of the hollow cover being positioned distally of the distal end of the sleeve such that distal movement of the sleeve in relation to the cover causes the cover to invert.
27. The tool member cover and cover deployment device assembly of claim 26 , further including a closure device configured to close one end of the cover.
28. The tool member cover and cover deployment device assembly of claim 27 , wherein the closure device includes a drawstring.
29. The tool member cover and cover deployment device assembly of claim 28 , wherein the cover deployment device is separable from the cover.
30. The tool member cover and cover deployment device assembly of claim 26 , wherein the at least one expandable member includes a first expandable member positioned about the distal end of the sleeve and a second expandable member positioned about the proximal end of the sleeve.
31. The tool member cover and cover deployment device assembly of claim 26 , wherein the at least one expandable member is a resilient O-ring.
32. The tool member cover and cover deployment device assembly of claim 26 , wherein the first sleeve half-section includes at least one projection and the second sleeve half-section includes at least one slot, the at least one projection being slidable into the at least one slot to maintain alignment between the first and second half-sections when the first and second half-sections moved between the contracted and expanded positions.
33. The tool member cover and cover deployment device assembly of claim 32 , wherein the at least one projection includes two projections and the at least one slot includes two slots.
34. The tool member cover and cover deployment device assembly of claim 26 , wherein the sleeve defines at least one annular recess, the at least one annular recess being configured to receive the at least one expandable member.
35. The tool member cover and cover deployment device assembly of claim 34 , wherein the at least one annular recess includes a first annular recess positioned about the distal end of the sleeve and a second annular recess positioned about the proximal end of the sleeve, each of the first and second annular recesses being configured to receive one of the at least one expandable members.
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JP7103611B1 (en) * | 2021-03-01 | 2022-07-20 | リバーフィールド株式会社 | Fittings and cover unit |
Also Published As
Publication number | Publication date |
---|---|
WO2004011037A3 (en) | 2005-09-29 |
WO2004011037A2 (en) | 2004-02-05 |
US20050236459A1 (en) | 2005-10-27 |
US9119604B2 (en) | 2015-09-01 |
EP1572250B1 (en) | 2011-04-27 |
AU2003269931A8 (en) | 2004-02-16 |
EP1572250A2 (en) | 2005-09-14 |
US20130256381A1 (en) | 2013-10-03 |
AU2003269931A1 (en) | 2004-02-16 |
DE60336923D1 (en) | 2011-06-09 |
US8579937B2 (en) | 2013-11-12 |
ES2364043T3 (en) | 2011-08-23 |
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