CA1069009A - Surgical method - Google Patents

Surgical method

Info

Publication number
CA1069009A
CA1069009A CA250,727A CA250727A CA1069009A CA 1069009 A CA1069009 A CA 1069009A CA 250727 A CA250727 A CA 250727A CA 1069009 A CA1069009 A CA 1069009A
Authority
CA
Canada
Prior art keywords
tissue
wound
needle
fastener device
fastener
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA250,727A
Other languages
French (fr)
Inventor
Matthew H. Wykoff
Richard L. Kronenthal
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Johnson and Johnson Medical SAS
Original Assignee
Ethicon SAS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethicon SAS filed Critical Ethicon SAS
Application granted granted Critical
Publication of CA1069009A publication Critical patent/CA1069009A/en
Expired legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D1/00—Surgical instruments for veterinary use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0419—H-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0454—Means for attaching and blocking the suture in the suture anchor the anchor being crimped or clamped on the suture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464—Suture 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

Abstract

ABSTRACT

A method for closing wounds and surgical incisions in mammalian tissue which comprises fastening an approxi-mated wound or incision with a series of devices compris-ing a short filament with a head on each end, each device being surgically placed so that the filament traverses the wound or incision within the tissue while one head of the device engages the surface of the tissue on either side of the wound or incision. Apparatus is provided for the surgi-cal placement of the device.

Description

~ 9 ~0 ~ ETH-403 BACKaRoUND OF THE INVE~TION
Fleld of Invention:
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Thl~ invention relates to the surg1cal closure of wounds or incision~ to a}lo~ healing, and more p~rti- :
cularly to a method for e~fecting ~u~h clo~ure utili~ing a series of indivldual wound closure device~.

Wound~ ~nd surgical inclsions are conventio~ally closed by the time honored technique of ~imply sewlng the ~ound clo3ed wlth needle and suture. Needle~shapes and ~izeB and suture ~izes and compositlon~ have been developed over the year~ to meet the demand~ o~ many dlfrerent suturing ~ 10 situations, ~rom delic~te ~n~StMmo8e8 and ophthalmic work to : the less dem~ding approximation o~ ~kin ~nd fa~cl~.
Because the procedure of sewing ~p a wound ~nd tylng suturPs ~an be r~her tedlous and time consumlng, 1 .
the art of 3tapling wa~ developed a~ an alternate to sutur-ing in certain applic~tion~. The art i replete ~ith device~ and designs of staples and st~ple appliers for surgical use, and such ~evices have now been widely accepted :~ by the medical profes~ion.
The . pre~ent ~nvention ha~ for an ob~ect providing a ~urther alternative to suturing or stapling for ~ound ~: closure which~ i~ fa~t, inexpenslve and ef~icient. It i~
a ~urther ob,~ect of thi~ inrentlon to provide a new method for closing m~n~alian ti~sue, particularly skin, rnuscle and ~ascia. It ls a ~ret further ob~ect of thi~ lnvention to
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provide a method for closing surgical incisions in the skin which, when applied to animals, has less tendency to be clawed or bitten out by the animal. Still other objects of this invention will be apparent from the ensuin~ description and claims.

,; SUMMARY
Wounds and surgical incisions in mammalian tissue are closed and fastened for healing by placing a fastening device through and across the wound opening. The fastening devices comprise a short filament of a length sufficient to span the wound, with a restraining head on either end of the filament. The fastening device is passed through the tissue to be fastened by means of a hollow slotted needle adapted to receive one head of the fastener within the needle with the attached filament extending therefrom through the slot.
The needle carrying one end of the fastener is passed through and across the wound and, upon exiting the tissue on the side of the wound op~osite the point of entry, the head of the fastener is disengaged from the needle, whereupon the needle is withdrawn leaving the fastener in place.
The fasteners are conveniently H-shaped devices constructed of a flexible and resilient biocompatible material which may be either absorbable or non-absorbable in body tissue. A series of fasteners placed in close proximity along the length of the wound would effectively close the wound and enable natural healing to proceed. ~on-absorbable fasteners are removed from skin closures by snipping off one head and withdrawing the fastener with the opposite head.

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3~3 According to a broad aspect of the present invention there is provided a method of closing a wound or incision in mammalian tissue to facilitate the healing thereof. The method comprises approximating the tissue at the wound and inserting a hollow needle through the tissue and across the wound whereby the needle is in communication with the surface of the tissue on either side of the wound. A fastener device is also provided comprising a filament member terminated at each end by anchoring means. One end of the fastener device is passed through the hollow needle until the anchoring means at the end of the fastener device is discharged from the end of the needle. The hollow needle is then wlthdrawn from the -tissue while maintaining the fastener device substantially stationary relative to the tissue to dis-engage the needle from the fastener device and the tissue.
The fastener device remains in the tissue with the filament member traversing the wound through the tissue and the anchoring means restraining the filament and tissue from a point on the surface of the tissue on either side of the wound.

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DESCRIPTION OF DRAWINGS
FIGURE 1 is a front view of a typical surgical fastener of this invention.
FIGURE 2 is a view in perspective of the fasteners of FIGURE 1 being used to close skin in a surgical procedure FIGURE 3 is a view in cross-section of a fastener being placed across the wound as in FIGURE 2, FIGURE 4 is a side view in cross-section of the fastener of FIGURE 2 in place across a wound.
FIGURE 5 shows a wound closed with a series of fasteners.
FIGURE 6 is another view in cross-section of a fastener being placed across the wound in a Lembert-type closure.
FIGURE 7 is a side view in cross-section of the fastener of FIGURE 5 in place across the wound.
FIGURE 8 is a view in perspective of one type of fastener.
FIGURE 9 is a view in perspective of another type ; 20 of fastener.
DESCRIPTIO~ OF PREFERRED EMBODIME~TS
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The present invention relates to a method for closing wounds or incisions in mammalian tissue with a series of individual fastener devices. Each fastener device comprises a filament member of sufficient length to span the approximated wound from a point on either side of the ~ -wound, and anchoring means on each end of the filament to prevent the filament from pulling through the tissue. The method of the invention is particularly useful for closing `
skin, muscle (both smooth and skeletal) and fascia.

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In a preferred embodiment, a hollow needle is utilized to insert the fastener through the tissue and across the wound. The tissue is approximated at the wound and the hollow needle is passed into the tissue rom a point on one side of the wound and on through the tissue until the tip of the needle exits the tissue on the opposite side of the wound. The path of the needle is not unli~e that used in conventional suturing. While in closing a wound by suturing, the needle and a length of attached suture are passed com-pletely through the tissue, the hollow needle in the presentcase is inserted only far enough to penetrate through the tissue to form an open communication with both sides of the wound. The anchoring means on one end of the fastener device is then passed through the hollow needle until it is discharged from the tip of the needle on the far side of the wound. ~he needle is then withdrawn from the tissue while the fastener is restrained in -the tissue by the anchoring means on the far side of the wound, until the needle is - completely disengaged from the fastener and the tissue. The fastener is thus left in the tissue with the filament of the fastener traversing the wound along the path created by the needle and with the anchoring means engaging and restraining the surface of the tissue on either side of the wound.
The method and application of the present invention will be more fully understood and appreciated by reference to the ensuing description and drawings. Figure 1 illustrates a preferred fastener design wherein filament member 11 is terminated at each end by rod shaped heads attached to the '"`' .

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filament member at a point substantially equidistant from the ends of the rod member. Figure 2 is a view in perspec-tive of the fasteners of Figure 1 being used to close the skin in a surgical procedure. The skin is approximated and raised by grasping with forceps and held while fasteners 10 are inserted in a row through both layers of skin 15 by means of hollow needle 16. Referring further to Figure 3, ;
fasteners 10 are individually inserted through the approxi-mated tissue 15 via a slotted hollow needle 16 equipped with a push-rod 17. ~Iead 12a of fastener 10 is contained within the needle with filament 11 extending there~rom through the slot of the needle. After the needle has passed completely through the tissue 15 and extends from the tissue on both sides of the wound, fastener head 12a is pushed out of needle 16 by push-rod 17 and needle 16 is withdrawn from the tissue leaving the fastener in place as shown in Figure 4. The pro-cess is repeated until a series of fasteners have been placed through and across the wound as shown in Figure 5. The fasteners are conveniently spaced as required to effect complete and continuous closure of the wound, with the heads 12 of adjacent fasteners in close proximity and in a uniform line along the entire length of the wound.
The present invention is not limited to any parti-cular fastener design or method of placement, but includes the broad method of wound closure wherein the approximated wound is held in position for healing by a series of indivi-dual filaments which pass through and across the approximated wound and hold the tissue in a closed position by means of anchoring means at each end of the filament.

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One alternative fastener design is illustrated in Figure 8 wherein filament 21 is terminated at each end by -flat discs 22, T~is type fastener is adapted to be completely contained within a hollow needLe for placement across the wound as illustrated in Figure 6 where fastener 20 is contained within needle 26 equipped with push-rod 27. Since the fastener is completely contained within the needle, ; needle 26 need not be slotted as described above for needle 16. After needle 26 is passed through tissue 25 on both sides of the wound, fastener 20 is pushed through the needle until head 22a exits the end of the needle. ~eedle 26 is then withdrawn from the tissue while fastener 20 is held stationary relative to the tissue by push-rod 27 until the needle is completely withdrawn leaving the fastener in place as shown in Figure 7.
The fasteners and needle devices which may be used in the practice of the present invention are known in the art where they have been used for non-surgical applica-tions such as a-ttaching buttons or tags to fabrics or mending torn fabric~ Fasteners such as that of Figure 1 and slotted hollow needle devices for use therewith are disclosed in U.S.
patents 3,470,834, 3,103,666, 2,069,878,3,494,004, 3,39g,432, 3,518,729 and U.S. Des. 213,418. Fasteners such as that of Figure 8 and hollow needle devices for use there-with are disclosed in U.S. Patent 3,209,422.

In the practice of the surgical method of the present invention, it is of course preferable that the fasten-- ers and the needle device be sterilized before use. This is ', 30 readily accomplished using conventional techniques of ethylene oxide, radiation, or heat sterilization. Sterile devices and -;
.

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fasteners may be packaged in sealed containers to preserve sterility until ready for use. The practice of the present invention in surgical procedures is illustrated by the following examples where the fasteners and needle devices were sterilized with ethylene ~xide prior to use.

A beagle dog was subjected to a laparotomy. The incision was approximately 10 cm long. The muscle and peritoneal layers were closed as one layer using eight H-shaped fasteners with a lO mm filament and 6 mm heads ; placed at approximately 12 mm intervals along the total length of the wound~ The skin was closed in a similar manner with the same type fasteners. The wound healed uneventfully. The exiernal skin fasteners were removed after 7 days and the incision continued to heal with minimal scarring. It was noted that none of the fasteners had been removed by the animal as is commonly experienced with the use of sutures for skin closure.
` EXAMPLE 2 A female beagle dog was subjected to a cystotomy.
The bladder mucosa was approximated with 5/0 chromic catgut.
The incision in the muscle which was 2 cm long was closed with four fasteners similar to those of Figure l having a filament 2 mm long attached to a 6 mm rod at one end and an enlarged oval knob at the other. The fasteners were placed in appro~i-mately 6 mm intervals in a manner analogous to an interrupted Lembert inverting stitch. A 4 cm incision in the abdominal -~ ~6~
wall and skin were each closed with four ~I-shaped fasteners as described in Example 1. The wound healed uneventfully and the external fasteners were removed after 7 days. It was noted that none of the fasteners had been removed by the animal~
~ fter six (6) weeks, the animal was sacrificed and a necropsy examination conducted. There were no adhesions on the peritoneal surface of the bladder and no dehiscence of the abdominal wall or visceral adhesions to the incision line. Encapsulation of the internal fasteners was minimal.
Healing throughout was very satisfactory.
The fasteners may be constructed of any of a wide variety of materials or combinations of materials. The filament portion of the fastener which traverses the wound is preferably flexible and biologically inert to avoid unfavorable tissue reaction. The heads of the fastener are conveniently molded from the same material as the connecting filaments although different compositions ~can be used if desired. Materials such as nylon and polypropylene which have found wide use as suture materials can be used to mold non-absorbable fasteners with good results. Other synthetic suture materials such as polyeth~lene terephthalate and homopolymers and copolymers of glycolide and lactide can also be used with good results. The glycolide and lactide polymers have the additional advantage of being absorbable in tissue and thus are particularly well suited for internal use in application where long-term maintenance of wound support is not required.
Where the heads of the fastener are to be of a composition different than that of the connecting filament, the filament is most conveniently fabricated from a length of suture material which may be monofilament or multifilament -9 ~:

and natural or synthetic~ Synthetic monofilaments include polyolefins and nylon, while natural monofilaments include catgut and collagen~ Synthetic multifilaments include braided, twisted, and covered sutures of nylon, polyethylene terephtha-late, and homopolymers and copolymers of glycolide and lactide.
~atural multifilament sutures include braided, twisted, or covered silk, cotton and linen. Fastener heads may be attached to short lengths of the suture material by cementing, crimping, fusing, molding, or any other suitable method whereby the filament may be securely attached. One such embodiment of a composite fastener is illustrated in Figure 9 wherein stainless steel heads 23a and 23b are each attached by swaging to multi-filament suture 24 which enters the fastener head at the midpoint thereof with one end of the suture filament contained within one-half section of each head.
The examples described herein are for purposes of illustration only and the invention is not limited thereby.
; Many other variations in fastener construction and implanta- -tion devices will be apparent to those skilled in the art.
' 20 For example, while the closure of wounds or incisions with the ; fastener devices described herein is most conveniently and preferably practiced with the use of a hollow needle as described, the hollow needle is not essential to the practice of this invention. For example, the fasteners may be position-ed across the wound by inserting the fastener directly through a preformed hole, or by sharpening one end of a rod-shaped fastener head to serve as a needle and facilitate penetration of the tissue by that end of the fastener. ~hese and other variations of the method disclosed and illustrated herein are accordingly included within the scope of the present invention.

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Claims (15)

The embodiments of the invention in which an exclu-sive property or privilege is claimed is defined as follows:
1. A method of closing a wound or incision in mammalian tissue to facilitate the healing thereof which comprises (a) approximating the tissue at the wound; (b) inserting a hollow needle through the tissue and across the wound whereby the needle is in communication with the surface of the tissue on either side of the wound; (c) passing one end of a fastener device comprising a filament member terminated at each end by anchoring means through the hollow needle until said anchoring means at said end of the fastener device is discharged from the end of said needle; and (d) withdrawing the hollow needle from the tissue while maintaining the fastener device substantially stationary relative to the tissue to disengage the needle from the fastener device and the tissue, the fastener device remaining in the tissue with the filament member traversing the wound through the tissue and the anchoring means restraining the filament and tissue from a point on the surface of the tissue on either side of the wound.
2. A method of claim 1 wherein said anchoring means comprise rod members, each rod member being attached to said filament member at a point substantially equidistant from the ends of said rod member.
3. A method of claim 1 wherein said anchoring means comprise disc members, each disc member being attached to said filament member at a point substantially at the center of said disc.
4. A method of claim 1 wherein the fastener device is at least partially contained within the hollow needle while the needle is being inserted through the tissue.
5. A method of claim 2 wherein the hollow needle has a slot therein and one rod member of said fastener device is contained within the hollow needle with the filament member extending from said needle through said slot while the needle is being inserted through the tissue.
6. A method of claim 3 wherein said fastener device is wholly contained within the hollow needle while the needle is being inserted through the tissue.
7. A method of claim 1 wherein a plurality of fastener devices are inserted through the tissue and across the wound along substantially the entire length of the wound.
8. A method of claim 1 wherein said fastener device is comprised of a non-absorbable material.
9. A method of claim 8 wherein the fastener device is comprised of nylon, polyolefin, or polyester.
10. A method of claim 8 wherein the filament member of said fastener device is comprised of a flexible, non-absorbable material and at least one of said anchoring means is comprised of a rigid, non-absorbable material.
11. A method of claim 10 wherein at least one of said anchoring means is stainless steel.
12. A method of claim 10 wherein said filament member is comprised of a multifilament suture material.
13. A method or claim 1 wherein said fastener device is comprised or a biologically absorbable material.
14. A method of claim 13 wherein said biologically absorbable material is selected from the group consisting of catgut, collagen, and homopolymers and copolymers of glycolide and lactide.
15. A method of claim 1 wherein the filament member of said fastener device is comprised of a biologically ab-sorbable material and at least one of said anchoring means is comprised of a non-absorbable material.
CA250,727A 1975-04-23 1976-04-21 Surgical method Expired CA1069009A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US05/571,043 US4006747A (en) 1975-04-23 1975-04-23 Surgical method

Publications (1)

Publication Number Publication Date
CA1069009A true CA1069009A (en) 1980-01-01

Family

ID=24282094

Family Applications (1)

Application Number Title Priority Date Filing Date
CA250,727A Expired CA1069009A (en) 1975-04-23 1976-04-21 Surgical method

Country Status (7)

Country Link
US (1) US4006747A (en)
JP (1) JPS51130091A (en)
CA (1) CA1069009A (en)
DE (1) DE2617211A1 (en)
FR (1) FR2308349A1 (en)
GB (1) GB1549666A (en)
IT (1) IT1058181B (en)

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GB1549666A (en) 1979-08-08
US4006747A (en) 1977-02-08
IT1058181B (en) 1982-04-10
FR2308349A1 (en) 1976-11-19
JPS51130091A (en) 1976-11-12

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