CA2196074C - Spring-loaded reciprocable stylet holder - Google Patents

Spring-loaded reciprocable stylet holder Download PDF

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Publication number
CA2196074C
CA2196074C CA002196074A CA2196074A CA2196074C CA 2196074 C CA2196074 C CA 2196074C CA 002196074 A CA002196074 A CA 002196074A CA 2196074 A CA2196074 A CA 2196074A CA 2196074 C CA2196074 C CA 2196074C
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CA
Canada
Prior art keywords
cap
body element
stylet
holder assembly
fastener
Prior art date
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Expired - Fee Related
Application number
CA002196074A
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French (fr)
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CA2196074A1 (en
Inventor
Todd Charles Tomba
Edgar Gilberto Manosalva
Donald Jay Goldhardt
James David Morrow
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Abbott Laboratories
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Abbott Laboratories
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Publication of CA2196074A1 publication Critical patent/CA2196074A1/en
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Publication of CA2196074C publication Critical patent/CA2196074C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20Holders specially adapted for surgical or diagnostic appliances or instruments
    • A61B50/22Racks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06061Holders for needles or sutures, e.g. racks, stands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06114Packages or dispensers for needles or sutures
    • A61B17/06133Packages or dispensers for needles or sutures of parallelepipedal shape, e.g. made of rectangular or slightly oval panels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8695Washers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0406Pledgets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0416Packages or dispensers for suture anchors or for anchor applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417T-fasteners
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0454Means for attaching and blocking the suture in the suture anchor the anchor being crimped or clamped on the suture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06114Packages or dispensers for needles or sutures
    • A61B2017/06142Packages or dispensers for needles or sutures having needle- or suture- retaining members, e.g. holding tabs or needle parks

Abstract

A spring-loaded reciprocable styles holder assembly (39) includes a cap (40);
a hollow body element (41) partially nested within and reciprocable a major part of its length into the cap; a spring (54) urging the body element outwardly of the cap; and a styles (42) supported at one end by the cap and extending through and beyond the body element. The remote end of the body element (41) has a small borehole (45) through which the styles (42) extends. The remote end is also provided with attachment means for a hypodermic needle (47) with slotted tip (51) for T-fastener (48) emplacement, the needle telescopically surrounding the full length of the stylet. In a useful modification of the device and insufflation adapter (90) having a side port (94) for attachment of a hypodermic syringe is placed in line between the body element and the hypodermic needle. The styles holder assembly (39) with a slotted hypodermic (47) needle attached thereto may be used for emplacing a T-fastener (48) in a hollow organ of a person, such as the stomach.

Description

WO 96!09005 PCTIUS95102656 1',',~!"1 t 2 ~ 9607 SPRING-LOADED RECIPROCABLE STYLET HOLDER
The present invention-relates to surgical instruments and more particularly tothe use of-T-shaped-tension members in certain surgical procedures, and even more particularly to a device for-conveniently holding-and reciprocating a atylet used in controllably electing a T-shaped tension member from a slotted hypodermic needle during its emplacement in a surgical procedure.- . _._ -__ . ._..
U~S. Re.34,021 discloses a method and apparatus for fixing a hollow-organ of a patient to the body wall of the patient using T-shaped-tension members, hereinafter referred to as "T-- fasteners". Examples of surgical procedures which may utiliz-a the teachings of U.S.-Re.34,'021-are the-securing of a patient's stomach or bowel in apposition-to the abdominal wall during a gastrostomy-or jejunostoray ~roceaure: These procedures are performed to facilitate the insertion of a feeding tube through the abdominal wall directly into the stomach or bowel. Examples of individuals who may require such -a procedure-include burn patient-s,whose-daily caloric needs are high;-critically-ill, weak or comatose patients who may be unable to swallow food; and patients suffering from a diseased or traumatized Qsophagus, who may be unable to swallow food.
Increasingly, a new-class of persons requiring such treatment include patients -infected with the HIV virus.
A relatively new method of-placing-a -gastrostomy tube or jejunostomy tube is-described in U.$. 5,151,086.-In this patent, a laparoscopic procedure is described which utilizes instruments and equipment which pass through the skin and the tissue of-the body wall at the surgical site and to the hollow organ to be penetrated.-The-laparoscopic procedure- requires, the handling and use-of many instruments and supplies including a.nasogastric_tube, scalpel, needles, syringes, T-faeteners, a J-guide wire, dilators, a gastrostomy tube or jejunostomy tube, astylet and water solublelubricant. In the procedure described. herein as well as in U.S. 5,151,086, each T-fastener is inserted into a slotted, hollow needle to facilitate placement within thelhollow organ. Care must be p._ 2~9~074 taken to avoid ejecting the~T-fastener prematurely before it is properly emplaced, or,else it will be-wrongly placed within the patient, or, if outside the body of the patient, it will likely fall onto a non-sterile surface and have to be discarded. Considering the number of items that must be handled during such procedures it is evident that there is a need for a convenient apparatus-amdmethod of holding and controlling the stylet used to eject the T-fasteners from the slotted hypodermic needle used for-emplacement.
In a first aspect of the invention there is provided a spring-loaded reciprocable stylet holder assembly having a cap with a closed end and an open end a"nd a longitudinal axis; a hollow body element having a longitudinal axis, an open end portion partially nested within and reciprocable partially into the cap, and a substantially closed end, the longitudinal axes of the cap and body element being -coincidental; a spring urging the body element outwardly of the cap; and a stylet supported at one end thereof by the cap, the stylet slideably extending through the body element along the longitudinal axis thereof and through a borehole_in-the-closed end of. the body element and well beyond the body element. Preferably, the cap and body element are both cylindrical and means is provided for retaining-the body element in a-telescoping reciprocal relationship with the cap,i.e.,- the body element is restrained from sliding completely out of the cap. It is further preferable to support the stylet from a post or plunger that depends within thecap from the closed end thereof to about the open end and is reciprocable into and out of the hollow cylindrical body element. It is also preferrQd to use a coil--springas the spring urging the body element out of the cap and from around the plunger, and, it is preferred to position the coil spring around the plunger and substantially coextensively therewith. , In a further aspect of the invention the distal end of the body element is provided with means for attachment of a hypodermic needle for the emplacement of a T-fastener, the attachment means being; usually, the female-portion of a conventional luer lock fitting. The stylet extends through the assembly, including the attachment means, and--the needle is ~s . ,v;;~.,~~A~6074 attached so as to telescopically cover the stylet. With a needle of the requisite gauge mounted to the luer lock, and having the-tip, proximal to the beveled-end and_contiguous thereto, slotted to receive a T-fastener for use in insertion ~ thereof, and with-the needle and the stylet being each of an appropriate length,so that in'the assembly the stylet is - extendible, by manipulation of the holder, to the lower, or distal, end of the slot, there-is provided apparatus ready to be loaded-with a T-fastener for emplacement of the same in the stomach or bowel of a patient in a surgical procedure.
In a further aspect of the invention, an insufflation adapter with a T-connection is placed in-line, i.e., in series, between the needle attachment means of the body element of the present stylet-holder-and the needle in the assembly for emplacement of a-T-fastener, thus providing means for injecting into-or withdrawing from-a hollow organ of a patient any appropriate fluid, i.e., liquid or gas, without disconnecting the assembly.
Preferably the insufflation adapter comprises a body portion with a passageway formed therethrough and a hemostasis valve in the passageway, and complementary luer lock fittings at each end, the body portion having a laterally projecting T-connection communicating with the passageway distal to the hemostasis valve and having a flexible tubing extension terminating in a female fitting for connecting to a syringe, such as a luer lock fitting, and a fluid-tight closure for-the luer lock fitting, such as a complementary screw-on cap, thus facilitating insufflation as may be desired or needed during the procedure of emplacingT-fasteners.
In another aspect of the invention a novel method of controllably holding and ejecting a T-fastener from a hypodermic needle tip during placement in a hollow organ of a patient comprises.
providing an assembly of the-spring-loaded reciprocable atylet holderof tha invention including a stylet mounted therein, and equipped with means for attaching a hypodermic needle to the.distal end of the body element thereof, and a hypodermic needle hald.by the attachment means with the stylet . ' ~~;~ :x1..96074 extending therethrough to adjacent the tip thereof, the needle being of the requisite gauge and length for_inSQrtion of a T-fastener within,a hollow organ of a patient.and having a slotted tip portion to slideably receive and hold a T-fastener;
placing a T-fastener~with an attached filament, ordinarily a suture, within the slot of-the needle with the distal end of the stylet resting within the needle closely adjacent the T-fastener; -inserting the needle into a hollow organ of the patient at a pre-selected site;
sufficiently pressing.down the cap of the stylet holder over the body element and against the urging of the-spring within the stylet holder to move the stylet to eject the T-fastener from the tip of the needle; and withdrawing the assembly of the stylet holder and the needle from the body of the patient.
Preferably the filament is attached to the T-fastener at about the mid-length of the fastener and the filament is grasped along with the stylet holde_r;during_insertion of the needle, and when the assembly of stylet holder and needle is withdrawn from the body of the patient, retaining means are applied to the filament outside the body while the filament is held under tension to position the-body organ.
5 pCTIUS95l02656 ' ~::2,~ 9074 Brief Descr~pt~on of the Drawings Fig. 1 is-a ~erspectW a view of the stylet holder assembly of the invention;
Fig. 2 -is an e3cploded perspective view of the stylet holder assembly shown in Fig. 1;
Fig. 3 is a-slightly enlarged side view of the cap of the stylet holder assemb7.y shown in Fig. 1;
Fig. 4 is a-top, or plan,- view-of the cap shown in Fig.
3;
Fig. 5 is a bottom view of thecap shown in Fig. 3;
Fig. 6 is a-view of the cap in longitudinal section taken along the diametric-Line 6-6 ofFig_5;-Fig. 7 is a view of -the cap in longitudinal section taken along the modified-diametricline 7-7 of Fig.-5;
Fig. 8 is-a slightly enlarged side view of the body element of -the stylet holder assembly of Fig. 2;
Fig. 9 is a-side view of the body element of Fig. 8, upon being rotated-90 degrees about.its longitudinal axis from the view in Fig.-8;-Fig. 10 is a-top, or plan, view of the body element of Fig. 9;
Fig.-11 is-a-bottom view of the body element of Fig. 9;
Fig. i2-is-a-view in-diametric section taken longitudinally along Line 12-12 of Fig. 1D;
Fig. 13 is a-perspective view in both transverse section and diametric section for purposes of illustration, being taken transversely a little above the conical narrowing of the cylindrical cavity of the body element, and, longitudinally along the diametric line of a perspective view of the body element as seen in Fig. 2, and rotated about one-eighth of a turn about its longitudinal axis;
Fig. 14 is a greatly enlarged view in transverse section of the stylet holder assembly of Fig. 1, taken along line 14-14, with the coil spring that surrounds the plunger omitted for the-sake-of--reducing the complexity of the view;

~'.''2,19~074 Fig. 15 is a view in longitudinal section taken along the modified diametric line 15-15 of Fig. 14;
Fig, 16 is a view in section similar to that of Fig. 15, but with the cap telescoped over the body element causing the stylet to be inserted.further through the body--element, and, the coil spring-being compressed to permit the telescoping movement;
Fig. I'7 is a side vieF,v of the stylet holder assembly of the invention with a slotted hypodermic needle attached at the luer lock fitting and with a fi-fastener positioned in the .
needle with one-half of the T-fastener visible in the slot at the beveled-tip of the needle with a filament extending from the T-fastener as part of a T-fastener assembly, including a pledget, a washer and retaining-crimping elements, not yet crimped, threaded onto the filament;
Fig. 17A is an enlarged fragmentary view of the portion of the assembly encircled in Fig. 17, illustrating details-of the beveled needle tip and the T-fastener and the adjacent distal end ofthe s-tylet, the T-fastener being lodged in the needle with half of it visible in-the slot of the needle, the slot extending from the proximal edge of the beveled portion, and the filament extending from the~T-fastener next to the-proximal end of the slot;
Fig. 17B is an exploded perspective view of a T-fastener installation kit of the type disclosed in U.S. 5,307,924 employing a stylet holder assembly of the present invention;
Fig. 18 is a perspective view of the stylet holder assembly of the invention with a slotted needle attached as the assembly is conveniently held in the hand of a surgeon, while the slotted needle is about to be loaded with a T-fastener from a loading block of a T-fastener installation kit;
Fig. 19 is a greatly enlarged.fragmentary detailed view of the encircled portion of Fig.-18, with a portion of the ..
loading block cut away and removed, showing how the T-fastener is held in the loading block of theinstallation kit which guides the needle tip into proper position to receive the T-fastener with the attached filament extending out through the ;,,; ,~21,9~074 slot;
Fig. 20 is a view similar to Fig. 18showing the stylet holder assembly of the invention with slotted needle attached and the needle tip inserted into the loading block during ' loading of a T-fastener-; ., , , Fig. 21 is a view similar to Fig. 20 showing the T-fastener assembly, including the filament with the pledget, the washer and the crimping-elements all threaded on the filament, as the T-fastener assembly is conveniently held by the same hand as the stylet holder assembly of the invention;
Fig.-22 is a view similar to Fig. 21 showing a T-fastener loaded into--the-slot~.ed needle and-the-needle-tip lifted away from the loading block and with the filament and the retaining elements grasped along with the stylet holder assembly.
Fig. 23 shows the preparation for the emplacement of a T-fastener in a-hollow organ of a patient, here the stomach, using a laparoscopic procedure for guidance, the body of the patient being shown in fragmentary sectional view;
Fig: 24 is a view in section of a portion of the body parts as in Fig. 23 with the hand of a surgeon shown in full guiding the stylet holder-assembly of the invention with slotted needle attached and loaded with-a T-fastener with the T-fastener assembly attached thereto, the needle having been inserted through the abdominal wall, through the peritoneal cavity and into the wall of the hollow body organ, here the stomach;
Fig. 25 is a view similar to Fig. 24 showing the needle of the assembly extending into the hollow organ and with the organ partially distended-by insufflation while the cap of the stylet holder assembly has been pressed down over the body element by the index finger of the surgeon,-causing the stylet to eject the T-fastener within the hollow organ;
Fig. 26 is a view similar to Fig. 25 showing the cap of the stylet holder assembly released from compression against the coil spring and the hand of the surgeon_pulling up on the stylet holder assembly and-the filament of the T-fastener assembly, thus pulling the T-fastener into place, and further, WO 95/09005 P ' _ ~~ ~ ;-, PCT/US95/02555 ,; , ~~'~195074 as a consequence, pulling the wall-of the hollow organ up towards the abdominal wall;
Fig. 27 is a.fragmentary view of the. body parts, somewhat similar to Fig. 26, showing the wall of the hollow organ anugged up against the abdominal wall with the T-fastener -inside the hollow organ and the filament.aecured outside the abdominal wall with a pledget and washer arid a crimping -element around the end of the filament that has been trimmed back to the crimping-element;
Fig. 28 is a side view of a modified form of ari assembly according to the invention in which an insufflation_valve within an adapter that serves as a valve-body is placed in-line between the novel stylet holder assembly and the slotted needle for emplacement of a T-fastener; the insufflation valve body having a aide "T" port with a short connecting-piece of tubing with a luer lock fittingon xhe distal end closed with a cap, the adapter and its side connection providing-for carrying out insufflation without disconnecting the stylet holder assembly;
Fig. 28A is a fragmentary view, partly broken away and in section, of a form of adapter for insufflation purposes which threadably connects to the body element of the stylet holder assembly instead of using a luer lock style-connection, the body element having complementary internal threading formed therein the distal end thereof;
Fig. 29 is a side view of the adapter per sg with appropriate male and female luer Lock fittings for in-line attachment and with the cap closure, shown in exploded view, for the luer lock fitting at the free end. of the tubing connected-to the side."T" port. It should-be understood that within the valve body shown in this view, as well as in Fig.
28A, there is a conventional hemostasis valve assembly with a borehole therethrough-the axis thereof for passage of the stylet through to the needle, the valve being between the side "T" port and the attachment of the adapter to the body element; and _ Fig. 30 is a viewin section of another embodiment of the etylet holder assembly of the invention in which the coil ?96,074 :, ._ spring-that urges the,body element outwardly of the cap is positioned inside the body element instead of inside the cap.
In the assembly shown, the cap has-been pressed dovin, telescoping part way over the body element and thus extending ~ the stylet further out through the borehole in the substantially closed end of the body element. The normal - return position of-the-cap,when~ released is indicated in dotted outline.
W 0 96109005 _ - . - - p~~S95/02656 r. .. r, ,, . , ~, ~?96~74 brief Descriration of the Invention The various aspects of the invention will be better understood with reference-to the dYawings-in wIzich like parts are identified by like reference numerals. -Referring now to Figs. 1, 2 and 15, the stylet holder assembly of the invention, indicated generally by-there~erence-numeral 39-, is seen to consist mainly of a hollow-cap-40 that-telescopes ' slideably over a hollow body element 41. While both parts can -be made with square or rectangular or oval-cross-sections of appropriate complementary shape and dimensions~they will most conveniently be made round in section, i.-e=-~-both parts are cylindrical in nature An elongated stylet 42,,normally a thin metal rod, is supported by a post or plunger 43 extending axially within the cap 40 from the closed end 44 to--about the full length of the cap, the stylet-42 extending in the axial direction from the plunger 43 and--being cemented or otherwise attached thereto, or more usually, thereunto.
For the purposes -o~-this-description and theappended claims, it should be understood that the terms "distal" and "proximal" are taken with respect to the closed end-44 of the hollow cap 40 when the components of the stylet holder assembly areasaembled in their operative configuration.
If desired, the plunger may be formed at its distal end with an axially bored hole or cavity into which an end of the stylet 42 is inserted and cemented thereto,-or the hole may be tapped and the end of-the stylet threaded and screwed into it.
The plunger-may be in the form of a cylindrical rod, preferably of a fluted nature, with longitudinal ridges or flanges that extend the length thereof, but more preferably takes the shape of at least three and up'to =about five, but usually four, elongated vanes or flange-like portions 57, each joined to the others by one elongated edge along a-common axis with the flange-like portions about equi-angularly spaced -about the common axis, and being-integrally formedinto a unit. Preferably, the plunger, when made with, for example, four flanges, is x-shaped, or star-shaped in section, the -junction of the flanges, i.e., the longitudinal core of the plunger, being of relatively small diameter: Preferably the W0 96/09005 ~ ~ ,.~ ~ i ~ ~ ~ ~ ~ PCTIiTS95102656 entire plunger is integrally formed with the cap and made of a polymeric resin or composition, such as, a high density polyethylene-The stylet 42 extends axially along and through the hollow body element 4i, whei~~the,bo.dy element and the cap 40 are assembled-together for use, and out through an axial borehole 45 fprmed in the substantially closed end 46 of the body element. The substantially closed -end 46 is shaped to provide attachment means for a-slotted hypodermic needle used foremplacement of-a T-fastener, such as the needle 47 used for the T-fastener 48 shown in Fig.- 17-. Usually the distal portion of the closed--end 46 of thebody element41 is- shaped as the female portion of a conventional luer lock fitting, such as the cavity 56 shown in section in Figs. 12, 15 and 16, so that the substantially closed end 46 receives, in locking relationship, a conventional needle hub, such as needle hub 62 shown in Fig. 17, which is the male portion of a luer lock fitting. -It is essential, as will be-evident upon referring to Figs. 17 and 17A, that when a needle is mounted on the stylet holder assembly 39 the stylet 42 extend to, or substantially to, the proximal edge 49 of the slot in the slotted portion 53 of the needle extending upwardly from the beveled portion 50 of the needle tip 5Z, in order that the distal end 52 of the stylet be in position to eject a T-fastener, such as T-fastener 48 slideably held in the slotted portion 53 of the needle 47, upon the cap 40 being pressed to telescope over the body element 41, thus thrusting the post 43 part way through the body element 41 and the stylet 42 carried by the post 43 being thrust_further through the needle-47. It may be perceived readily that the distal end 52 of the stylet 42 must be close enough to the slotted portion 53 of the needle 47, ' and especially to the proximal end of a T-fastener 48 loaded into the slotted portion, in the assembled apparatus, so that the range of reciprocation of the cap 40 over the body element 41 will permit ejection of a T- fastener 48 held in the tip end of the needle right next to the beveled portion, half within theslotted portion 53 of needle47, and half further into the needle than the closed end 49 of the slot.

Referring to the exploded view of the-stylet holder assembly in Fig. 2 and the views in section, Figs. 15 and 16, it is seen that spring means 54 is used to urge the body element 41 outwardly of nesting within the cap 4D. Such a spring is needed in order to support the stylet 42 in the - -assembly 39 slightly above any T-fastener 48 inserted temporarily into the slotted portion 53 of the needle 47, until the surgeon using the assembly is ready to eject the T- .
fastener, as in placement thereof within the hollow organ of a patient. As shown, a coil spring is preferred, such as coil spring 54. Coil spring 54, of an appropriate diameter to slide readily over plunger 43 and its longitudinal flanges 57, is positioned with-the proximal end 55 of the spring bearing-up against the closed end44 of the cap 40, and with the other, i.e., distal, end 58 of the spring -close.Eothe free end 59-of-the post 43. For stable, uniform operation, the cavity 60 of the body element 41 must be of sufficient diameter to little more than readily slideably receive the plunger 43. The , proximal end 61 of the hollow body element 41 that extends into the cap 40, that is, the face of the open upper end, must have sufficient wall thickness, or a suitable flange provided, to serve as a stop for the coil spring 54 to press against resiliently in urging the body element 41 outwardly-of the telescoped position within the cap 40 when manual pressure on the closed end 44-of cap 40 is released.
This is necessary so that, as shown in Fig. 17A, the stylet 42 will be held far enough up the needle shaft for.the loading of a T-fastener 48 in the slotted portion 53 of the.
needle 47 employed, with the T-fastener thrust into the needle with normally only half of-the T-fastener visible in the slotted portion,-the insertion stopping-,with-the attached-filament at the mid-length of the T-fastener at the closed end 49 of the slot.
Turning to Figs. ID, 12 and 13, a suitable stop may take the form of a set of radially inwardly extending ribs 63 on the inside of the body element 41: These ribs extend longitudinally from the proximal end 6l of the body element 41 down to about the substantially closed end 46_and serve also as guides for-the plunger 43, meshing between the flanges 57 ~, r; ;~~ 9 6.~ 7 4 of the plunger 43 and acting as spacers between the plunger 43 and the body element 4i. While three such ribs 63 about equally spaced are adequate, four ribs, preferably about equally spaced, are--more: preferred for smooth operation.
Preferably,-as-'shownriri Figs. 8-11, the body element 41 at its proximal end 61 is-shaped with a peripheral annular ridge or boss 64 while the cap 40 at its open end 65, as shown in Figs. 5, 6 aiid-7, is shaped-with a radially inwardly extending annular ridge or boss-66. In order to be able to utilizethese features cooperatively as a convenient means for retaining the upper end of the body element 41 at least slightly within the open, lower end of the cap 40, and still be able to assemble the parts together, it is essential that the inner. diameter of the inward annular ridge 66 of the cap 40 be only slightly smaller than the outer-diameter of the peripheral-ridge 64, and that at least one of the annular ridges, and preferably both, be formed of resilient material, such as a synthetic polymeric resin, for example, an ABS resin of copolymerized acrylonitrile, butadiene and styrene.
Assembly is further-aided by interruptedly segmenting, and thus making discontinuous, at least one, but preferably both, annular ridges, reducing the stiffness of the ridges, as seen in the bottom view of the cap 40 in Fig. 5, and the bottom view of the body element 41 in Fig. 10. Beveling the peripheral ridge 64, whether segmented or not, to make it flared with the greater diameter away from the open end 61 of the body element as seen in Figs. 2 and 8, also will ordinarily make assembly easier while still retaining resilient retentiveness, and-disassembly possible with a rather slight amount-of forcing. As seen in Figs. 8 and 10, the ridge-64 may-be omitted along portions of a pair of opposing sides of the body element, for example, along lines tangential to the sides as shown in the figures, thus further making assembly and-disassembly easier, without eliminating the retentive action-of the remainder of .theridge 64.
If desired, as-shown iri Fig. 5, the cap 40 may also be provided with several, preferably four, radially inwardly extending longitudinal ridges-67 that are best about equally spaced around the edge of the end of the cap and located r' ~~ r'42'1 9 6~ 7 between segments of the annular ridge 66, while the annular peripheral ridge 64 of the body element 41 is formed with-complementary slots 68 therethrough. These structural features together provide for more stable, controllable-uniform action in using the-assembly to insert a needle into a hollow organ of a patient and then pressing the-cap telescopically over the body element, ejecting a T-fastener from the needle and within the hollow organ.
In general, it is preferred that the parts be designed to utilize longitudinal ribs.or ridges and.segmentation thereof where appropriate in producing, e.g., cylindrical parts that will smoothly reciprocate telescopically, in accordance with good molding practice,in the manufacture of plastic parts:
If desired, the closed end 44 of the cap 40 may be externally shaped concavely as -seen iri the top-view in Fig. 4, for more comfortable retention of a finger tig on the cap.
during use. The periphery of the cap adjacent the closed end 44 may also be textured or grooved to make the cap easier to manipulate with gloved fingers. See, for example, the grooves 69 in Figs_ 1, 2 and 3.
Forming the body element 41 with short external longitudinal ribs.70 at the substantially closed end 46 is desirable in order to provide a stop for the telescopic motion of the cap 40 over the body element 41, and also to strengthen the structure of -the luer lock fitting which is ordinarily used as the attachment means 56 for the needle .47 used for T-fastener emplacement. Referring now to F-igs:- 12 and 13, forming the body element 41 with a cylindrical cavity 60 that converges conically at the substantially closed end 46 to a borehole 45 provides a further stop means that comes into effect if the plunger43 reaches the conical portion, as illustrated in Figs. 15 and 16.
In Fig. 17 there is illustrated an embodiment 39 of the stylet holder assembly of.the invention ready for typical use with a slotted needle 47 attached and with a T-fastener 48 inserted in the slot 53 of the needle. The T-fastener has a filament 72 attached at its mid-length, and, threaded on the filament, ready for use, is a cotton pledget 73, a viasher 74, R'0 96/09005 ~ , PC1'/US95I02656 ~' ''.,' l.'~ s and crimpable elements 75. The cotton p-ledget, washer and crimpable elements together serve as retaining means at the level of the external body surface of the patient for the filament under tension after the T-fastener has been emplaced and the hollow organ pulled into-position internally against the body wall, e.g., the abdominal wall-The stylet holder a'ss~m~~.y is conveniently readied using the kit of U.S. 5,307,924 which is depicted in Fig. 17B. The kit 76 consists of-a block 77 with specially shaped cavities 78, each holding one T-fastener 48 in a vertical position such that it can be readily placed in the slotted portion 53 of the type needle 47-usedfor the-purpose, so that the T-fastener 48 is positioned as shown in Fig. 17A, within the needle 47 with the T--fastener entirely above the beveled tip 51 of the needle and half of the T-fastener above the slotted portion 53. The kit also- includes a suitable base layer or sheet 79, e.g., of heavy paper orof cardboard with flaps formed thereof-and raised sufficiently to serve as retaining or storage means for the filament 72 attached to each T-fastener and the retaining elements threaded ~hereon. In-Fig. 19 there is shown the details of construction of a convenient form of a cavity 78 of the base or-block 77 for positioning each T-fastener so that it will slide into-the proper place in the slotted needle. The opening of the-cavity 78 is countered to readily guide a needle tip thereunto, and-the-bottom of-the-cavity is stepped down to a smaller-diameter-to-force the T-Fastener up past the beveled tip of the needle-into-the slotted portion 53. A
lateral slot 81 of the cavity 78 permits the filament 72 attached at mid-length of the T-fastener to extend laterally out of the way during positioning the T-fastener in the needle slot 53 as seen in Figs. 18 and 20.
After the T-fastener-48 is positioned or-loaded in the needle 47, the filament 72 and retaining means 73,74,75 thereon are conveniently picked up and-held with one hand-by the surgeon, together with the stylet holder assembly 39 and needle 47 as seen in Figs. 21 and 22.- After the surgeon has laparascopically located the appropriate site for inserting a T-fastener into an insufflated hollow organ, such as the stomach 71 of a patient, as illustrated-in Fig. 23, the s:.ylet WO 96109005 ~ ~ ,, -,, - - ~ . PCTYUS95102656 ;: ' ;:'~'~ 2196074 holder assembly 39, with attached needle-47 with T-fastener 48 loaded therein, is picked-up together with the filament 72 and retaining elements, 73,74,75 and-conveniently and controllably and confidently held with-one hand by the surgeon and inserted into the hollow organ of the patient, as seen in Fig. 24.
Then, the T-fastener 48 is simply and conveniently ejected inside the hollow organ by the surgeon pressing down on the closed top end 44 ofthe cap 40, as with the index finger, against the pressure of the coil spring 54 within the assembly 39, thus extending the stylet 42 further through the needle 47 to the beveled tip 50, whereupon the T-fastener 48 is ejected from the needle slot 53 in which-it had been loaded,-as depicted in Fig. 25.
Thereafter; the sty7.et holder assembly 39 and the filament 72 together with the retaining elements 73,74,75 are withdrawn from the body of the patient and-sufficient tension applied to the filament 72 to pull the-T-fastener 48 and thus the wall of the hollow organ up toward the-abdominal wall as shown in Fig. 26. After the wall of the hollow organ has been drawn up sufficiently with tension on the filament 72 pulling the T-fastener 48, and with the cotton pledget73firmly against the exterior of the abdominal wall, the washer 74 is pressed down against the pledget 73 and the crimpable element or elements 75 against the washer, and the crimpable elements crimped securing the filament 72, the unneeded tail of which is cut off, completing the T-fastener-emplacement. Usually four of such T-fasteners are used, being placed at the corners of a square through which a feeding tube, e.g., is to be -inserted. -In a useful modification of-the assembly of the invention, as illustrated in Figs.-28 and 29, an insufflation adapter, indicated generally by the numeral 90, having a hollow body 91 with attachment means 92,93 at respective ends, is attached to the body element 41 by engaging the attachment means 92 with the complementary interior surface defining attachment means cavity 56 within the substantially enclosed end 46 of the body element 41. See cavity 56 in Figs. 15 and 16. The attachment means cavity 56 is normally a female luer lock fitting, as is the attachment means 93, while attachment WO 96109005 , ; PCTIL1S95/02656 means 92 is normally a male luer lock fitting.
The hollow body 91 of-the insufflation adapter 90 is provided with a conventional hemostasis valve that bridges the passageway,-through the ho~l~qw;-body and controls movement of any fluid therethrough and the valve has a -central perforation or borehole therethrough through which the stylet 42 slideably extends. A lateral fluid connection in the form of a "T" or aide port 94 to the hollow body 91 connects to a short length of hollow tubing 95.
A hemostasis valve is a check valve consisting of a plurality of layers of thin flexible plastic disks bridging a valve body type passage and-provided with sufficient axial compression to prevent flow therethrough of a fluid, such as a body Fluid or gas.,NOnetheless, the axial compression may be adjusted so that the central axial perforation here permits resilient movement of the stylet therethrough without passage also of fluid.
The plural layer hemostasis valve is located between the side port 94 and the attachment means 92 which connects to the attachment means cavity 56 of the body element 41. The valve is inside the threaded end of-the hollow body 91 of the adapter and is surrounded by the nut 98 threaded onto the hollow body and attaching the male luer lock fitting 92. Nut 98 is integrally formed with and concentrically around the end of the tube 99 p~~he male luer lock fitting. The tube 99 is of a diameter to be slid into the hollow body 91. The end of the tube 99 is preferably provided with a slightly raised circumferential ridge, while the externally threaded end of the hollow body 91 is also provided with a slight internal annular ridge for resilient retention of the parts. Threading the nut 98 onto the hollow body 91 forces the end of the tube 99 inside the hollow body 91 against the hemostasis valve and tightening the nut 98 permits compression of the valve layers around-the stylet, thus providing an adjustable degree of sealing and of ease of sliding the stylet.
At the end of_ the tubing 95 is a luer lock fitting for connection with, e.g., a hypodermic syringe for the purpose of carrying out insufflation as may be indicated for the patient.
i7 The tubing is closed with a luex lock fitted cap for positive closure when the syringe (not shown) is attached.
The foregoing embodiment of,the assembly affords the-carrying out of insufflation without having to.disconnect the assembly and avoiding what may be awkward manipulations.
If desired, the substantially closed end 46a of the -hollow body element 41a illustrated in the fragmentary view in Fig. 28A, may be intereally threaded and the adapter body-91a threaded externally and complementarily thereto to provide a simple manner of connecting the adapter body 91a in the modified type of assembly corresponding to that shown in Fig.
28, for use in carrying out insufflation without having to disconnect the assembly in order to utilize a hypodermic syringe. - _.
In another embodiment of the stylet holder assembly of the invention seen in Fig. 30, the coil spring urging the body element out of the cap is positioned within the body element instead of on top of it, that is, at one end of-it, and bears against the bottom of the cavity of the body element instead of against the top-rim of the body element. The coil spring also bears against the distal end-of the plunger instead of the closed end of the cap, and is not positioned within the cap, except to the extent the plunger is-telescoped within-the cap.
Turning now to Fig. 30, the stylet holder assembly, referred to generally as 39a, is seen to have a cap 40a with a plunger 43a depending from the closed end 44a thereof. The plunger 43a is nested within the cylindrical cavity 60a of the hollow body element 41a, while the hollow body element 41a extends telescopically into the cap-40a. A coil-spring 54a bears against the distal end of the-cavity 60a adjacent the substantially closed end 46a of the body element, and oppositely against the lower or-distal end 59a of the plunger 43a. A stylet 42a is attached to the distal end 59a of the -plunger 93a and extends freely slideable through a small borehole 45a in the substantially closed end 46a of the body element 41a. The substantially closed end 46a of the body element 41a is shaped as a fema h luer lock fitting 56a.

WO 96/09005 ~ , ~ ~ ~ ~ ~ PCT/US95101656 . , , . ;~ t-, Without the complexity. of the annular and peripheral ridges and longitudinal ribs of the cap and the body element described aboue, the parts are somewhat easier to mold, though not as smooth and reliable acting in operation.
Among the advantages of the stylet holder assembly of the invention are the ease and simplicity of handling and the comfortable cohtrol by the user resulting in considerable peace of mind when approaching the ~roce~ure in which the assembly is used.

Claims (13)

CLAIMS:
1. A spring-loaded reciprocable stylet holder assembly comprising:
a cap having a closed end and an open end and a longitudinal axis, an inner engagement means located adjacent the open end and a post extending from the closed end of the cap along the longitudinal axis thereof;
a hollow body element having a longitudinal axis and an open end portion, the open end portion being partially nested within and reciprocable partially into the cap, and an opposite end that is substantially closed, having a borehole therethrough, the longitudinal axes of the cap and body element being coincidental, the hollow body element further comprising an outer engagement means located adjacent the open end for cooperation with the inner engagement means of said cap to retain the open end portion of the body element partially within the cap;
a spring within the stylet holder assembly, the spring being positioned between a portion of the cap and a portion of the body element so as to urge the body element longitudinally outwardly of the cap; and a stylet supported at one end thereof by and within the cap and along the longitudinal axis thereof, the stylet being supported by attachment to the post extending from the closed end of the cap, the stylet slideably extending through and beyond the borehole in the substantially closed end of the body element along the longitudinal axis thereof; and the substantially closed end of the body element having means for attaching a hypodermic needle thereto so as to telescopically cover with the hypodermic needle the portion of the stylet extending beyond the substantially closed end of the body element.
2. The stylet holder assembly of claim 1, wherein said inner engagement means is an inner substantially annular boss adjacent the open end of said cap and said outer engagement means is an outer substantially annular boss adjacent the open end portion of said body element end with the boss of the body element being positioned further within the cap and being of slightly greater outer radius than the inner radius of the boss of the cap, the bosses cooperating to retain the open end portion of the body element partially within the cap against the urging of the spring.
3. The stylet holder assembly of claim 2, wherein at least one of the annular bosses is segmented, and thus interruptedly discontinuous.
4. The stylet holder assembly of claim 2, wherein the boss of the body element is shaped as a sharp-ridged beveled flange with the greatest radius in the axial direction away from the end of the body element within the cap.
5. The stylet holder assembly of claims 1, 2, 3, or 4, wherein the cap and the body element are both cylindrical and the closed end of the cap has an inner surface and said post is an elongated plunger portion that extends from the inner surface along the longitudinal axis of the cylinder to about the open end of the cap and telescopes within the body element when the body element is reciprocated into the cap.
6. The stylet holder assembly of claim 5, wherein the plunger is in the form of at least three elongated flanges each conjoined to the other flanges along a longitudinal edge thereof at a common line to form a single axis for the structure that is star-shaped in section.
7. The stylet holder assembly of claim 6, wherein the plunger has four longitudinal flanges about equally spaced around the single axis.
8. The stylet holder assembly of claim 5, wherein the plunger portion has a distal end and the end of the stylet supported by the cap is attached to the distal end.
9. The stylet holder assembly of claim 5, wherein the spring is a coil spring that surrounds the plunger portion.
10. The stylet holder assembly of claims 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein the means for attaching a hypodermic needle to the body element is a luer lock fitting.
11. The stylet holder assembly of any one of claims 1 to 10, further comprising a hypodermic needle attached to the body element by the attachment means therefore, the hypodermic needle having a beveled tip, and a slotted portion contiguous to the short side of the bevel for use in placement of a T-fastener, the hypodermic needle telescopically covering the stylet and the stylet being of the requisite length to extend through the hypodermic needle to about the position of a T-fastener loaded in the slotted portion, and there being sufficient range of reciprocation of the stylet by the stylet holder assembly for ejection of said T-fastener.
12. The stylet holder assembly of claim 11, wherein the hollow flexible tubing has a distal end and the distal end is provided with a luer lock fitting for attachment of a hypodermic needle.
13. The stylet holder assembly of claims 1, 2, 3, 4, 10 or 11, wherein the cap and the body element are both cylindrical.
CA002196074A 1994-09-19 1995-03-06 Spring-loaded reciprocable stylet holder Expired - Fee Related CA2196074C (en)

Applications Claiming Priority (3)

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US308,242 1994-09-19
US08/308,242 US5531699A (en) 1994-09-19 1994-09-19 Spring-loaded reciprocable stylet holder
PCT/US1995/002656 WO1996009005A1 (en) 1994-09-19 1995-03-06 Spring-loaded reciprocable stylet holder

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CA2196074A1 CA2196074A1 (en) 1996-03-28
CA2196074C true CA2196074C (en) 2005-08-02

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EP (1) EP0782411B1 (en)
JP (1) JP3589466B2 (en)
AT (1) ATE246473T1 (en)
AU (1) AU702525B2 (en)
CA (1) CA2196074C (en)
DE (1) DE69531455T2 (en)
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JP3589466B2 (en) 2004-11-17
ATE246473T1 (en) 2003-08-15
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EP0782411A1 (en) 1997-07-09
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EP0782411B1 (en) 2003-08-06
AU1977395A (en) 1996-04-09
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MX9702013A (en) 1997-06-28
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JPH10505777A (en) 1998-06-09
US5531678A (en) 1996-07-02
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US5531699A (en) 1996-07-02
CA2196074A1 (en) 1996-03-28

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