CA1249194A - Arrangement for applying a tissue adhesive - Google Patents

Arrangement for applying a tissue adhesive

Info

Publication number
CA1249194A
CA1249194A CA000511285A CA511285A CA1249194A CA 1249194 A CA1249194 A CA 1249194A CA 000511285 A CA000511285 A CA 000511285A CA 511285 A CA511285 A CA 511285A CA 1249194 A CA1249194 A CA 1249194A
Authority
CA
Canada
Prior art keywords
chamber
syringe
syringe bodies
bodies
syringe body
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
CA000511285A
Other languages
French (fr)
Inventor
Johann Eibl
Thomas Seelich
Georg Habison
Heinz Redl
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.)
Oesterreichisches Institut fuer Haemoderivate
Original Assignee
Immuno AG fuer Chemisch Medizinische Produkte
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=3522110&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA1249194(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Immuno AG fuer Chemisch Medizinische Produkte filed Critical Immuno AG fuer Chemisch Medizinische Produkte
Application granted granted Critical
Publication of CA1249194A publication Critical patent/CA1249194A/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
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00495—Surgical glue applicators for two-component glue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing

Abstract

ABSTRACT OF THE DISCLOSURE:

An arrangement for applying a tissue adhesive based on human or animal proteins, to seamlessly or seam-supportingly connect human or animal tissue or organ parts by uniting with blood-clot-promoting coagulation factors (thrombin). The arrangement includes a plurality of syringe bodies commonly actuatable by pistons and to which a connecting head is attachable. The syringe bodies have equal effective strokes, yet one of them, i.e., that destined to contain the protein solution, has a cross sectional area that is two to nine times larger than the other one(s). There may be applied tissue adhesives having a fibrinogen content of from 2 to 12 %.

Description

~Z~94 The invention relates to an arrangement for applying a tlssue adhesive based on human or animal proteins, to seamlessly or seam-supportingly connect human or animal tissue or organ parts, seal wounds, stop bleedings and the like, which tissue adhesive solidifies in situ by uniting with blood-clot-promoting coagulation factors, which arrangement comprises a plurality of syringe bodies ending in joining pieces and commonly actuatable by pistons to contain the components to be applied, wherein a connecting head is attachable to the joining pieces of the syringe bodies, w~ich includes a separate conveying channel for each of the components to be applied and optionally for a medical propellant.
An arrangement of this type is described in U.S.
patent No. 4,359,049. As components, a protein solution ~; containing factor XIII and fibrinogen (tissue adhesive), ~`
on the one hand, and a solution containing thrombin, on the other hand, may be used. The components are mixed in a mixing needle attached to the connecting head and are
2~ applied onto the wound area to be treated or protected.
~ When realizing tissue adhesions or treatments, the ;~; protein solution and the thxombin solution usually are ~ obtained by dissolving lyophilisates. In doing so, one may ;~ ~
be faced with the problem, in particular in a surgical emergency situation, that the preparation of the protein solution takes an undesirably long time because of the poor solubility of these components. It is, of course, possible to shorten the dissolution time o~ the protein :~P

~12~
2424~-418 component hy usin~ a larcJer amount of solvent, yet, when mixing the protein solution with the -thrombin solution at a volume ratio of 1 : 1, as has been common practice so far, even the clotting mlxture is diluted to such an extent that a significant reduction in the ultimate tensile strength of the adhesion consequently will occur.
The invention aims at avolding this difficulty and has as its object to desi~n the known arrangement with a view to shortening the dissolution time when preparing a protein solution from ~ lyophilisate, without reducing the ultimate ténsile strength of the adhesion.
According to one broad aspect of the invention there is provided an arrangement for applying a tissue adhesive that - solidifies in situ by uniting with blood-clot-promoting coagulation factors, comprising:
a plurality of syringe bodies ending in joining pieces;
a piston in each of said plurality of syringe bodies for commonly actuating said syringe bodies;
a connecting head attached to said joining pieces of said syringe bodies and provided with a separate conveying channel for each of the componenks to he applied;
each of said syringe bodies having equally effective ,~
`~ strokes; and one of said syringe bodies having a cross-sectional area that is two to nine times laryer than the cross-sectional area of the remaining syringe bodies, said one syrlnge body containing an adhesive proteln solution having a fibrinogen content of from 3 to 12%.

'~

2~
24242-4~8 According to another broad aspecl of ~he invention there is provided a device for dispensing a plurality of interreactable flu,Ld, comprisin~:
a p~urality of syringe bodies a connectiny head intereonnecting the discharge ends of each of ~he syringe bodies;
first piston means in each of said syrinye hodies ~or actuating said syringe bodies;
first floating piston means in one o~ said syringe`bodies for dividiny said one syringe body into a first chamb~r and a second chamber; and first by-pass means in said one syringe body for allowing fluid from said second chamber to mix with fluid in said first by-pass means in said one syrlnge body for allowing fluid from said second chamber to mix with fluid in said first chamber when said first floating piston mean,s is adjacent said first by-pass means;
wherein sald one syringe body has a cross-sectional area that is two to nine ~.imes larger than the cross-secti~nal area ~'- 20 of the remaining syringe bodies.
According to a preferred embodiment, the syringe bodies may be designed as twin-chamber syringe bodies, with the - protein and the thrombin components heing stored in the mouth-side chambers in lyophilized form and the solvent being containecl in the remaining chambers.
~' Whila the protein solutions used for tissue adhesions so far have had fibrinogen contents of about 10% ~100 ~' ; 30
-3~-~9199L

mg/ml) or more, diluted protein solut:ions with fibrinogen cont.ents of from 2 to 7 ~ may be used accordiny to the invention, or there may be achieved adhesions of higher strengths when using protein solutions having fibrinogen contents of up to 12 %.
The invention is based on the principle that a favorable ra~io between the necessary reconstitution time of the protein lyophilisate and the strength of the adhesions will be obtained, if the hitherto usual mixing ratio of the protein solution and the thrombin solution of 1 is altered such that the protein component is dissolved in a relatively larger volume and the thrombin component is dissolved in a relatively smaller volume to compensate for the resulting lower protein concentration ~- of the protein component in the mixture of the two components.
If, however, adhesions of particularly high strengths are sought, an increase in the concentration of the adhesive proteins may be obtained according to the invention after having mixed the two components, without having to put up with~extended reconstitution times.
Mixing the two components in a su~ici~ntly exact ratio that deviates from 1 would be too difficult when using two separate syringes and has become possible only by the double syringe according to the invention.
The arrangement accordlng to the invention will now be explalned in more de-tail by way of two em~odiments and with reference -to the accompanying drawing, w~erein Figs.
1 an-l 2 are each a par~ially sectioned sidt3 vi63w oE the
- 4 -double syringe according to the invention.
In Fig. 1, a syringe body 1 is destined to contain the protein solution and a syringe body 2 is destined to contain the thrombin solution. Suitably, they are designed as disposable syringe bodies, made of synthe-tic material.
They are commonly inserted in U-shaped grooves 4, 5 of a holding means 3.
On the end of the holding means, finger grips 6 are provided, into which the flange ends 7 and 8 of the syringe bodies project such that the syringe bodies are fixed in the direction of their longitudinal axes. Pistons 21, 22 are guided in the syringe bodies, whose piston rods 9 and 10 project outwards. They comprise a common actuation means 11. A guiding rod 12 passes through a bore `;13 of the holding means.
: .
A connecting he~d 16 is attachable to the coni 14, 15 of the syringe bodies 1, 2 and incIudes conveying channels 17 and l8 ending in;ths front side 19 of the socket-like connecting head. A mixing needle 20 is attached to this -~20 socket.
-~As is apparent from~ the drawing, the syringe body 1 has a larger cross section than the syringe body 2; in the embodiment illustrated, the size ratio is 3 : 1, the -~volumes thus being 3 : l. The effectlve strokes of the two syringe bodies, i.e., the respective distances of the piston 21 and 22 entered in broken lines from the mouth sides 23, 2~, respectively, are identical.
With the modi~ied embodiment according to Fig. 2, the .

syringe bodies are designed as twin-chamber syringe bodies, with the lyophilized adhesive protein 26 being filled in the mouth-side chamber 25 of the syringe body 1 and thrombin 28 being filled in the mouth-side chamber 27 of the syringe body 2. In chambers 29 and 30 facing away from the mouth sides, the solvent is contained, viz., a solution containing aprotlnin in chamber 29 and a solution containing calcium chloride in chamber 30. Chambers 25 and 29 are separated by a floating piston 31, and chambers 27 and 30 are separated by a floating piston 32. By-passing ducts are denoted by 33 ~nd 34.
The pistons 21 and 22 are fastened to piston rods 9 and 10. Upon actuation of the same, the liquid is urged from chambers 29, 30 into chambers 25 and 27, respectively, via the by-passing ducts, thus preparing the solutions required for application. Even with this embodlment, the cross sectional ratio of syringe body 1 to syringe body 2 is 3 : l.
In the following Table, comparative assays are illus~rated, wherein, according to column "Standard", an adhesive protein solution was mixed with a thrombin :
solution at a volume ratio of l : l in the conventional manner by using the arrangement known from U.S. patent No.
4,359,049; according to columns 2 to 9, adhesive protein solutions having different fibrinogen contents were mixed with thrombin solutions in different mixing ratios by using the mode of operation and arrangements according to the invention, and the properties of the solidified , ~9~

adhesives were investigated.
The assays were carried out with a lyophilized tissue adhesive according to U.S. patent No. 4,414,976, wherein the sterile lyophilized preparations (each containing 370 mg dry substance, 200 mg thereof fibrinogen) contained in final containers at first were dissolved by applying the method described in Canadian patent No. 1,182,444 with so much solvent (aqua ad iniectabilia or aprotinin solution) that the fibrinogen concentrations indicated in column 2 of the Table were obtained. The dissolution time required in each case was determined and is indicated in column 4 of the Table.
The tissue adhesive solutions (first component) obtained as described were rapidly mixed with a thrombin-CaCl solution (second component) of the composition2 indicated in colums 5 and 6 at the volume ratio indicated in column 7 by using the application means according to the invention, were introduced into standardized separable casting molds and were incubated at 37 C for 30 minutes~
Subsequently, the solidified samples are removed from the casting molds, and the ultimate tensile strength was determined by means of an appropriate measuring device over a standardized cross section (0~0314 cm ). The results ob~ained (mean values of three measurements each, the individual values deviating from the mean value by no more than 15 ~) are summarized in the last column of the Table.
In col.umns 8 to 11, the final concentrations of fibri.nogen, aprotinin, thrombin and C:aC12 upon mixture of the two co~ponents are indicated.
From the results, it becomes apparent that the dissolution time required depends on the desired ~ fibrinogen concentra-tion in the first component (tissue - adhesive solution) prior to mixing the components, whereas the ultimate tensile strength depends on the final ~;~ concentration of flbrinogen upon mixture of the two components.
Thus, it has become possible, by using the application means according to the invention, to shorten the dissolution time required without deteriorating the ultimate tensile strength (Examples 1, 2, 3, 5, 6, 7) or, vice versa, to further increase the ultimate tensile strength without having to put up with extended dissolution times (Examples 8 and 9). Example 4 indicates that in some cases in which a slightly reduced ultimate tensile strength will do, extremely short dissolution times may be reached by using the application means according to the invention.
-; Example 5 reveals that the application means accordin~ to the invention is suited also for application of high thrombin concentrations; however, solidification -- of the tissue adhesive in such a case occurs so rapidly that the casting of standardized clots and hence the determination of the ultimate tensile strength are no longer possible~ Yet, the utilization of high thrombin concentrat.ions is o~ great importance in ~urgical i~24~9~

pxactice, in particular to stop bleedings.
A comparison of Examples 6 and 7 with Examples 1 to 3 finally proves that it is of no rel.evance either to the dissolution time required or to the ultimate tensile strength achieved, whether the dissolution of the lyophilized tissue adhesive is effected by means of aqua ad iniectabilia or by means of an aprotinin solution.

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Claims (10)

THE EMBODIMENTS OF THE INVENTION IN WHICH AM EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. An arrangement for applying a tissue adhesive that solidifies in situ by uniting with blood-clot-promoting coagulation factors comprising:
a plurality of syringe bodies ending in joining pieces;
a piston in each of said plurality of syringe bodies for commonly actuating said syringe bodies;
a connecting head attached to said joining pieces of said syringe bodies and provided with a separate conveying channel for each of the components to be applied;
each of said syringe bodies having equally effective strokes; and one of said syringe bodies having a cross-sectional area that is two to nine times larger than the cross-sectional area of the remaining syringe bodies, said one syringe body containing an adhesive protein solution having a fibrinogen content of from 3 to 12%.
2. The arrangement of claim 1, wherein said adhesive protein solution is prepared from a lyophilisate.
3. The arrangement of clam 1, wherein a second of said plurality of syringe bodies contains a thrombin solution.
4. The arrangement of claim 1, further comprising, first floating piston means in said one syringe body for dividing said one syringe body into a first chamber and a second chamber; and first by-pass means in said one syringe body for allowing fluid from said second chamber to mix with fluid in said first chamber when said first floating piston means is adjacent said first by-pass means.
5. The arrangement of claim 4, further comprising:
second floating piston means in a second of said plurality of syringe bodies for dividing said second syringe body into a third chamber and a fourth chamber; and second by-pass means in said second syringe body for allowing fluid from said forth chamber to mix with fluid in said third chamber when said second floating piston means is adjacent said second by-pass means.
6. The device of claim 4, wherein said first chamber contains the adhesive protein solution and said second chamber contains a solvent including aprotinin.
7. The device of claim 5, wherein the third chamber contains thrombin and the fourth chamber contains a solvent including calcium chloride.
8. A device for dispensing a plurality of interreactable fluid, comprising:
a plurality of syringe bodies a connecting head interconnecting the discharge ends of each of the syringe bodies;
first piston means in each of said syringe bodies for actuating said syringe bodies;
first floating piston means in one of said syringe bodies for dividing said one syringe body into a first chamber and a second chamber; and first by-pass means in said one syringe body for allowing fluid from said second chamber to mix with fluid in said first by-pass means in said one syringe body for allowing fluid from said second chamber to mix with fluid in said first chamber when said first floating piston means is adjacent said first by-pass means;
wherein said one syringe body has a cross-sectional area that is two to nine times larger than the cross-sectional area of the remaining syringe bodies.
9. The device of claim 8, further comprising, second floating piston means in a second of said syringe bodies for dividing said second syringe body into third and fourth chambers;
second by-pass means in said second syringe body for allowing fluid from said fourth chamber to mix with fluid from said third chamber when said second floating piston means is adjacent said second by-pass means.
10. The device of claim 8, further comprising means for commonly actuating said first piston means.
CA000511285A 1985-06-20 1986-06-11 Arrangement for applying a tissue adhesive Expired CA1249194A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AT0183885A AT382783B (en) 1985-06-20 1985-06-20 DEVICE FOR APPLICATING A TISSUE ADHESIVE
ATA1838/85 1985-06-20

Publications (1)

Publication Number Publication Date
CA1249194A true CA1249194A (en) 1989-01-24

Family

ID=3522110

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000511285A Expired CA1249194A (en) 1985-06-20 1986-06-11 Arrangement for applying a tissue adhesive

Country Status (8)

Country Link
US (1) US4735616A (en)
EP (1) EP0210160B2 (en)
JP (1) JPS61293443A (en)
AT (2) AT382783B (en)
CA (1) CA1249194A (en)
DE (1) DE3663109D1 (en)
DK (1) DK162739B (en)
ES (1) ES8707668A1 (en)

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