CA1075116A - Syringe assembly - Google Patents
Syringe assemblyInfo
- Publication number
- CA1075116A CA1075116A CA338,373A CA338373A CA1075116A CA 1075116 A CA1075116 A CA 1075116A CA 338373 A CA338373 A CA 338373A CA 1075116 A CA1075116 A CA 1075116A
- Authority
- CA
- Canada
- Prior art keywords
- syringe
- balloon
- chamber
- barrel
- pressure
- 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
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- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
SYRINGE ASSEMBLY
ABSTRACT OF THE DISCLOSURE
A syringe assembly comprising, a syringe having a chamber for retaining fluid, and a plunger having one end received in the chamber for pumping fluid out of the chamber.
The syringe assembly has means for limiting the amount of pressure generated by the syringe during pumping of fluid.
ABSTRACT OF THE DISCLOSURE
A syringe assembly comprising, a syringe having a chamber for retaining fluid, and a plunger having one end received in the chamber for pumping fluid out of the chamber.
The syringe assembly has means for limiting the amount of pressure generated by the syringe during pumping of fluid.
Description
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BACKGROUND OF THE INVENTION
~_ _ ___ The present invention relates to pumping devices, and more particularly to syringes.
Syringes are in common use today by physicians, nurses, and other hospital personnel for a variety of purposes; Fre-quently, syringes have been utilized to pump fluid into a body cav- ;
ity of a patient or a cavity in a therapeutic device under circum-stances where the pressure attained in the cavity should be limitedto a predetermined value. For example, during a spinal anesthesia procedure an anesthetic solution is pumped from a syringe through a needle into the sub dural space which is essentially an inelas- -tic pouch, and thus only a specified maximum amount of the solu-tion should be pumped into the space as determined by the pressure ; in the space. Similarly, various types of cardiovascular cathe-ters are often threaded into blood vessels, after which a balloon adjacent the distal end of the catheter is inflated through use of a syringe. If the balloon is overinflated, particularly when the catheter is placed in a smaller vessel, the vessel may be ruptured.
Numerous other ca~heters, such as endotracheal tubes and Foley catheters, are frequently provided with retention halloons which ; should not be overinflated, particularly when the balloon is obstructed by a body passage.
' 25 Few of the hospital personnel realiæe the considerable pressures which can be generated by a hand-operated syringe. For example, a 10 c.c. syringe may readily generate pressures in the range of 50-60 lbs./sq. in., the smaller syringes being capable of developing greater pressuxes for the same amount of force applied to the syringe plunger. It is thus apparent that considerable care must be exerciséd by the user when a syringe is u~ ed to ; pump fluid into a cavity space where only a limited amount of - . . . . . . .
~S116 pressure is desired. In the past, tactile sense has been used when forcing the plunger into the syringe to determine when the maximum pressure has been attained by resistance to plunger move-ment. Such a procedure produces speculative results, at best, in preventing harm to the patient, particularly since the syringe may readily generate relatively high pressures.
SUMMA~Y OF THE INV:ENTION
A principle feature of the present invention is the provision of a syrinye assembly of simplified construction which prevents damage to a patient during use.
The syringe assembly of ~he present invention comprises, a syringe having a chamber for retaining fluid/ and a plunger hav-ing one end received in the chamber for pumping fluid out of the chamber. The syringe assembly has means for limiting the amount of pressure generated by the syringe during pumping of fluidr Thus, a feature of the present invention is that the ; syringe assembly prevents generation of an excessive amount of pressure during use to preven~ possible damage to the patient.
Another feature of the invention is that the limiting means actuates at a predetermined pressure to relieve pressure in the syringe chamber~
A further feature of the invention is that the syringe assembly may provide means for indicating when the prede~ermined amount of pressuxe has been attained.
Still another feature of the invention is that in one embodiment the l:imiting means is associated with an extension of ~ a ~yxinge barrel defining the syringe chamber.
; A feature of the invention is that in one embodimentthe lLmiting means is associated with an adapter for the syringe.
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Yet another feature of the invention is that in one - embodiment the limiting means prevents movement o~ the plunger into the syringe chamber when the predetermined amount of pres-sure has been attained.
A further feature of the present invention is the provi-sion o~ a method for performing an epidural and a spinal anesthesia ' pxocedure.
Further features will become more fully apparent in the following description of the embodiments of this invention and from the appended claims.
DESCRIPTION OF THE DR~WINGS
In the drawings:
Fig~ 1 is a sectional view of one embodiment of the syr-inge assembly of the present invention as attached to a hollow needle;
Fig. 2 is a ~ragmentary sectional view o pressure limit-ing means in the syxinge assembly of Fig. 1 as actuated above a :, .
~ ~ predetermined pressure;
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Fig. 3 is a fragmentary elevational view of the syringe~, 20 assembly of Fig. l;
Fig. 4 is a fragmentary sectional view of another embodi-ment of the syringe assembly of the present invention as being applied to a catheter;
Fig. 5 is a sectional view of an adap~er in another embodiment of the syringe assembly of the present invention:
Fig. 6 is a sectional view of an adapter in another embodiment of the syringe assembly of the presen~ invention;
~ Flg. 7 is a sectional view taken subs~an~ially as indi--` cated along the line 7-7 of Fig. 6;
., .
~ Fig. 8 is a sectional view Qf the adapter of F~g. 7 illustrating pressure limiting means as actuated above a pre-determined pressure;
~75~6 Fig. 9 is a sectional view of an adapter in another embodiment of the syringe assembly of the present inventi,on;
Fig. 10 is a sectional view of the adapter of Fig, 9 illustrating valve means in the adapter as actuated above a p~-determined pressure;
, Fig. 11 is a sectional view taken substantially as indicated along the line 11-]1 of Fig. 9;
Fig. 12 is a sectional view of another embodiment of a syringe assembly of the present invention;
Flg. L3 is a sectional view of another embodiment of a syringe assembly of the present invention;
Fig. 14 is a sectional view of an adapter in another embodiment of the syringe assembly, of the present inventi,on;
Fig. 15 is a fragmentary elevational view of another embodiment of a syringe assembly of the present invention;
Fig. 16 is a fragmentary sectional view of the syringe assembly of Fig. 15;
Fig. 17 is a front plan view of another embodiment of a syringe assembly of the present invention;
Fig. 18 is a fragmentary sectional view taken substan-tially as indicated along the line 18-18 of Fig. 17; and ' Figs. 19 and 20 are fragmentary sectional views of additional embodiments of a syringe assembly of the present inven-~; tion. ' :`' DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to Figs. 1-3, there is shown a syringe assembly or syringe means generally designated 20 comprising a syringe 22. The syringe 22 has a hollow harrel 24 having a cham-' _4_ ~C~7S~
ber 26 for retaining fluid. The syringe also has a plunger 28 having a flexible plug 30 adjacent one end 32 of the plunger received in one end of the chamber 26. The pluy 30 ~ealingly enyages against the inner surface 33 of the syringe barrel 24, with the plunger being pushed into the chamber 26 to purnp fluid out of the chamber.
The syrinye 22 has an extension or extension means 3 projecting from an end of the barrel 24 remote the plunyer 28, with the extension 34 having a tip 36 receivable in the hub H of a hollow needle N. Of course, the tip 36 of the syringe exten-sion 34 may be connected to any other suitable device, ~uch as a catheter, as described below. The extension 34 has a passageway 38 which communicates with the syringe chamber 26 and the hollow needle N, when attached, and has a flexible balloon 40 which communicates with the passageway 38 through an opening 42 in the wall of the extension 34. The balloon 40 comprises a flexible sleeve which surrounds the extension 34, and has a pair of edges 44a and 44b secured to the outer surface of the extension 34 by suitable means 46a and 46b, such as adhesive. Thus, the balloon or sleeve 40 has its edges 44a and b sealed peripherally around the extension 34, such that it defines a cavity 48 int~rmediate the sleeve and the outer surface of the extension 34 which commu-nicates through the opening 42 with the passageway 38.
The balloon 40 is constructed to inflate when a prede-termined pressure has been reached in the passageway or chamber ofthe syringe, the particular pressure at which the balloon inflates being selected for the particular use contemplated for the syringe ; assembly. The pressure at which the balloon inflates may be con-trolled by a number of factors including the particular material 1 ~ .
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used for the balloon, such as latex, and the thickness, durometer, and elasticity vf the balloon, as well as the transverse and longi-tudinal radii of the balloon, acco:rding to the law of Laplace which holds that the pressure required to inflate a balloon i5 direct.ionally proportional to its tangential tension and inv~rsely ~ proportional to its transverse and lonyitudinal radii.
In use of the syr.inye for a spinal ~nesthe.sia proceduxe, the chamber is filled with fluid, such as an anesthetic solution, and the syringe tip 36 is attached to the hub H of the needle N, after which the tip T of the needle may be advanced through the tissue t, the potential epidural space e, and the dura mater d of the patientls body, and inserted into the sub dural space s adja-cent the spinal cord s'. The anesthetic solution is then ejected from the syringe chamber 26 into the sub dural space s by pushing the plunger 28 into the syringe chamber. Since the sub dural space is essentially an inelastic blind pouch filled with fluid, as shown in Fig. 1, and under a positive pressure, the balloon 40 of the syringe is selected to inflate at a predetermined pressure greater than the pressure in the sub dural space s. Consequently, as the solution is pumped into the sub dural space, the pressure builds up in the space until it reaches the predetermined pressure, after which the balloon 40 inflates, as shown in Fig. 2, and ~, relieves pressure build up in the space, thus preventing harm to ; the patient. Accordingly, the balloon 40 serves to limit the amount of pressure ~enerated by the syringe, and prevents ejection ~ -.
of further fluid into the needle N and sub dural space a~ter the predetermined pressure has been attained. The inflated balloon also serves as an indication to the user that the predetermined amount of pressure in the space or cavity has been reached, and ,:
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that the plunger should not be pushed further into the syringe chamber 26.
Another embodiment of the syringe assembly 20 of the present invention is illustrated in Fig. 4, in which like refer-ence numerals designate like parts. In this em~odiment, the exten-sion means 34 includes an adapter 50. If desired, a conventional syringe 22 may be used having a standard luer tip 36'. The adapter 50 has a tip 36 adjacent one end for connection to a catheter C', or other suitable device, such as the needle N, and a recess 52 adjacent the other end o the adapter for attachment to the tip 36' , of the syringe 22. A passageway 38 extends longitudinally through the adapter 50, and communicates between the syringe chamber 26 and the catheter C' when the ends of the adapter are connected to the syringe and ca-theter. The adapter 50 has a flexible sleeve or bal-loon 40 extending around the adapter and having its ends 44a and bsecured peripherally around the outer surface of the adapter by suitable means 46a and b, such as adhesive. The sleeve 40 defines a cavity 48 intermediate the sleeve and the outer surface of the adapter 50 which communicates with the passageway 38 through the opening 42.
In use, after the syringe has been filled with fluid, the adapter 50 is attached to the tip 36' of the syringe 22, and the tip 36 of the adapter 50 is attached to the catheter C'. The catheter may be of a type having a lumen L which communicates between a proximal end P of the catheter and a cavity C'' underly-ing a balloon B adjacent a distal end D of the catheter. For a cardiovascular catheter, as shown, the catheter is previously threaded through a vessel, and the balloon B is inflated through '`.t '' ' ' ' ,' '. ' . ,, ., . ' . .. '. ' :' ' ' ~'75~6 the lumen L by pumping fluid from the syringe chamber 26. When the partially inflated balloon B becomes obstructed by the wall of the vessel, and a predetermined amount of pressure is developed in the cavity C'' defined by the balloon B, the flexible sleeve 40 inflates to limit the amount of pressure generated by the syringe and pxevent overinflation of the balloon B, which otherwise might rupture the vessel.
It i~ apparent that-the pressure limiting or indicating ; means associated with the syringe assembly of the present inven-tion may be incorporated di~ectly onto the syringe itsel~, as previously described, or may be placed on the adapter which is connected to the syringe. In either case, the device operates in a similar manner to prevent harm to the patient. Thus~ for pur-poses of previous and future discussion, it is immaterial whether . 15 the limiting or indicating means is associated with the adapter or the syringe itself.in the syringe assembly, with the exception of the devlces described in connection with Figs. 12 and 13.
Another embodiment of the adapter 50 in the syringe assembly 20 is illustrated in Fig~ 5, in which like reference numerals designate like parts. In this embodiment, the adapter ;: 50 includes an outwardly extending thumb 56 having a channel 58 ; communicating with the passageway 38. The adapter 50 has a flex~
ible sleeve 40 extending peripherally around the thumb 56 and having its edges 44a and b secured peripherally around the thumb by means 46a and b, such as adhesive/ thus defining a cavity 48 communicating with the channel 58 and passageway 38 through the opening 42. The sleeve or balloon 40 inflates, as previously . described in connection with the syringe assembly of Figs. 1-4, .
~ ~ . -8-7S~6 to limit the amount of pressure generated in the passageway 3fl and the syringe chamber.
A further embodiment of the adapter 50 in the syringe assembly 20 of the present invention is i]lustrated in Fic3s. 6-8, in which like reference numerals designate like parts. In this embodiment, a balloon 40' has its peripheral edges 44' sealed by suitable means 46', such as adhesive, to an outer surface 60 of the adapter 50 to define the cavity 4~, which communicates with the passageway through the opening 42. As shown in Fig. 8, the balloon 40' inflates at a predetermined pressure, as previously described, to limit the amount of pressure generated by the ; syringe assembly.
Another embodiment of the adapter 50 in the syringe assembly 20 of the present invention is illustrated in Figs. 9-11, in which like reference numerals designate like part.s. In this -embodiment, a valve element 64 is supported in a chamber 66, with a head 67 of the valve element 64 having a face 68 for sealing against a seat 70 in the chamber 66. The head 67 has a stem 72 extending from an end of the head remote the face 68, with the stem 72 being received in a cavity 74 in the adapter 50. A heli-cal spring 76 surrounds the stems 72 and extends between a back ~, surface 78 of the cavity 74 and a back surface 80 of the head 67.
The adapter 50 has a channel 82 communicating between the passage-way 38 and the chamber 66 adjacent the seat 70, and a pair of channels 84a and 84b communicating between the chamber 66 and an outer surface 86 of the adapter 50. As illustrated in Fig. 9, .
the spring 76 biases the head 67 of the valve elemen~ to a first ~ position with the face 68 sealing agains~ the seat 70 to prevent : . ' 9_ , . . . . .. . .
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passage of fluid from the channel 82 into the chamber 66. How~
ever, when a predetermined amount of presxure is reached in the passageway 38, the spring 74 permits movement of the valve ele-ment to a second position with the face 68 of the head 67 spaced from the seat 70, as shown in Fig. 10, and fluid then passes from the passageway 38 through the channel 8~, chamber 66, and the channels 84a and b to the outer surface 86 of the adapter 50, as indicated by the direction of the arrows in the dra~ing. Thus, the-valve means is actuated a~ a predetermined pressure to relieve pressure in the passageway 38, and limit the amOunt of pressure generated by the syring,e assembly. The pressure a~
, which the valve means is actuated may be selected by the particu-lar structure of the valve assembly, such as the particular heli-,' cal spring 74 utilized in the adapter 50.
lS , Another embodiment of the syringe assembly 20 oE the present invention is illustrated in Fig. 14, in which like refer-ence numerals designate like parts. In this embodiment, the adapter 50 has an outer transparent cylindrical shield 51 defin-, ing a chamber 53, and a pair of extensions 55a and 55b extending into the chamber 53 and partially defining the passageway 38'~
The tubular sleeve 40 has its ends received on the extensions ' 55a and b and secured in place by suitable means 46a and b, such as adhesive. The sleeve 40 ~xpands to limit the amount of pres-sure generated by the syringe assembly, as previously describe~, and is visible to the user through the transparent shield to ~, determine when the sleeve has expanded. The shield serves to protect the sleeve, and air is permitted to pass from the cham-ber 53 through a vent 57 in the shield to permit expansion of '~ the sleeve.
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Another embodiment of the syringe assembly 20 of the present invention is illustrated in Figs. 15 and 16, in which like reference numerals designate like parts. In this embodiment, the flexible balloon or sleeve 40 extends around the syringe bar-rel 24. The slee~e 40 is secured to an outer surface 152 of the syringe 22 by suitable means 46a and b, such as adhesive, adja-cent the edges 44a and b of the sleeve 40, in order to define a cavity 4B intermediate the sleeve 40 and barrel 24 which communi-cates with the syringe chamber 26 through an opening 42 in the barrel 24~ The sleeve 40 inflates above a predetermined pressure, as pre~iously described, to limit the amount of pressure generated by the syringe.
Another embodiment of the s~ringe assembly of the pres-ent invention is illustrated in Figs. 17 and 18, in which like reference numerals designate like parts. In this embodiment, a balloon 40' has its peripheral edges 44' sealed by suitable means 46', such as adhesive, to the outer surface 152 of the syringe 22 to define the cavity 48, which col~nunicates with the chamber 26 through the opening 42. The balloon 40' inflates at a predeter-mined pressure, as previously described to limit the amount of pressure generated by the syringe.
Another embodiment of the syringe assembly 20 of the present inven~ion is illustrated in Fig. 19, in which like refer-ence numérals designate like parts. In this embodiment, the extensions 34 described in connection with Figs. 4-14 may be permanently affixed to the syringe tip 36' by suitable means 150, such as adhesiveO As shown in Fig. 20, the extensions 34 may be constructed as an integral part of the syringe 22, if desired.
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Another embodiment of the syringe assembly of the pres-ent invention is illustxated in ~ig. 12, in which like reference numerals designate like parts. In this embodiment, the barrel 24 of the syringe 22 is transparent, and the plunger 28 has a flexible plug 30 adjacent the one plunger end 32 which is received in the syringe chamber 26. The one end 32 of the plunger 28 includes a cent.rally located transparent member 90 having a cavity 92 facing the syringe chamber 26, with ,the tr~ns- ;
parent member 90 being visible through the-barrel 24. A flexible diaphraym 94 is supported by the .plug 30 a;nd extends across an opening 96 intermediate the caviky 92 in the transparent member 90 and the syringe chamber 26. When a predetermined pressure has been attained in the syringe chamber 26, the diaphragm 94 Elexes from a first position adjacent the opening 96, as shown by solid lines in the.drawing, to a second position received in the transparent member 90,,as shown by dotted lines in the'drawing.
The diaphragm 94 is thus ~isible to the user in its second posi-tion and serves as an indication that the predetermined amount of pressuxe has been reached in the syringe chamber., and that , 20 the user should cease pumping the syringe.
A further smbodiment of the syringe assembly of the present invention is illustrated in Fig. 13, in which like refer-ence numerals designate like parts. In this embodiment, the plunger 28 has a flexible plug 30'. adjacent the one plunger end 32'which seals against the inner surface 33 of the barrel 24.
The plug 30' has a:n annular slot 100 having one end 102 communi-cating wlth the syr'inge cavity 26, and defining an annular flex~
ible side wall 104 of the plug 30' adjacent the inner surface 33' . of ~he s.yringe barrel 24. The side wall 104 of the plug 30' flexes responsive to a predetermined pressurs in the syrings 12- ' ,. . , ~ .
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chamber 26, and engages against the inner surface 33 of the syr-inge barrel 24 to impede movement of the plunger into the syringe chamber. Thus, when ~he predetermined amount of pressure is yen-erated by the syringe, resistance to movement of the syringe plunger 28 into the syringe barrel 24 becomes noticeable to the user, and movement o the plunger is then stopped to prevent dam-age to the patient.
Thus, there has been described a syringe assembly which has means for limiting the amount o~ pressure generated by the syringe as~embly to prevent harm to a patient. In addition, the syringe assembly indicates to the user when the predetermined amount of pressure has been reached.
According to the present invention, methods are also pro-vided for performing an epidural and a spinal anesthesia procedure.
In a spinal anesthesia procedure, the tip of a needle, u~ed to per-form the pxocedure, is advanced through the body tissue t, the epidural space e, which is at a slight negative pressure, and the dura mater d into the sub dural space s, which is at a positive pressure, a~ previously described in co~nection with Fig. 1.
According ~o a method o~ the present invention, a balloon of the adapter in the syri~ge assembly is selected to inflate at a first predetermined pressure less than the pressure in the s~b dural space, and a balloon on the syringe, which is removably attached to the adapter, is selected to inflate at a second predetermined pressure greater than the pressure in the sub dural space When the needle tip T pierces the dura mater d and enters the sub dural space s, fluid in the space actuates the balloon on the adapter due to the higher pressure in the space relative the first pre-determined pressure, thus indicating that the needle tip is at the proper location in the space for performing the spinal anesthesia :
.. .. . . .~ . .
lQ~S~L~L6 procedure. The adapter may be removed from the needle and syringe, and the syringe is attached to the needle to eject anesthetic solu-tion into the sub dural space. The balloon on the syringe limits the amoun~ of pressure generated by the syringe to prevent harm to the patient, as previously described.
Alternatively, fixst and second adapter~ may be used in conjunction with a standard s~ringe, the first adapter having a balloon inflatable at the first predetermined pressure, an~ the second adapter having a balloon inflatable at the second predeter-mined pressure. The ~alloon of the first adapter is utilized to determine when the needle tip is located in the sub duxal space, after which the first adapter is replaced with the second adapter for pumping the anesthe~ic solution into the space.
A method is also provided for performing an epidural anesthesia procedure with the syringe assembly of the present inven-tion. After the tip of a needle, attached to a syringe or an adap-ter and syringe, is advanced into the ~ody tissue, the syringe plunger is pushed sufficiently into the syringe chamber to inflate a balloon on the syringe assembly with anesthetic solution from the chamber. The needle tip is then advanced toward the epidural space. When the needle ~ip enters the epidural space the solution from the ~yringe assembly flows into the space due to the pressure generated ~y the inflated balloon relative the negative pressure in the space. Thus, the balloon deflate~ and indicates to the user that the needle tip is properly located for performing the proce-dure. ~he anesthetic solution may then be eject~d from the syringe into the epidural space. Accordingly, the method of the invention prevents the user from improperly puncturing the duxa mater during the epidural anesthesia procedure.
~ The foregoing detailed description is given for clear-1~7~
ness of understanding only, and no unnecessary l.imitations should be understood therefrom, as modifications will be ob~ious to those skilled in the art.
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' .'"' " .'' - ', " . ' ' ~ '' ' ' ' ,' ' : ' . ' ., ' ' ' .
BACKGROUND OF THE INVENTION
~_ _ ___ The present invention relates to pumping devices, and more particularly to syringes.
Syringes are in common use today by physicians, nurses, and other hospital personnel for a variety of purposes; Fre-quently, syringes have been utilized to pump fluid into a body cav- ;
ity of a patient or a cavity in a therapeutic device under circum-stances where the pressure attained in the cavity should be limitedto a predetermined value. For example, during a spinal anesthesia procedure an anesthetic solution is pumped from a syringe through a needle into the sub dural space which is essentially an inelas- -tic pouch, and thus only a specified maximum amount of the solu-tion should be pumped into the space as determined by the pressure ; in the space. Similarly, various types of cardiovascular cathe-ters are often threaded into blood vessels, after which a balloon adjacent the distal end of the catheter is inflated through use of a syringe. If the balloon is overinflated, particularly when the catheter is placed in a smaller vessel, the vessel may be ruptured.
Numerous other ca~heters, such as endotracheal tubes and Foley catheters, are frequently provided with retention halloons which ; should not be overinflated, particularly when the balloon is obstructed by a body passage.
' 25 Few of the hospital personnel realiæe the considerable pressures which can be generated by a hand-operated syringe. For example, a 10 c.c. syringe may readily generate pressures in the range of 50-60 lbs./sq. in., the smaller syringes being capable of developing greater pressuxes for the same amount of force applied to the syringe plunger. It is thus apparent that considerable care must be exerciséd by the user when a syringe is u~ ed to ; pump fluid into a cavity space where only a limited amount of - . . . . . . .
~S116 pressure is desired. In the past, tactile sense has been used when forcing the plunger into the syringe to determine when the maximum pressure has been attained by resistance to plunger move-ment. Such a procedure produces speculative results, at best, in preventing harm to the patient, particularly since the syringe may readily generate relatively high pressures.
SUMMA~Y OF THE INV:ENTION
A principle feature of the present invention is the provision of a syrinye assembly of simplified construction which prevents damage to a patient during use.
The syringe assembly of ~he present invention comprises, a syringe having a chamber for retaining fluid/ and a plunger hav-ing one end received in the chamber for pumping fluid out of the chamber. The syringe assembly has means for limiting the amount of pressure generated by the syringe during pumping of fluidr Thus, a feature of the present invention is that the ; syringe assembly prevents generation of an excessive amount of pressure during use to preven~ possible damage to the patient.
Another feature of the invention is that the limiting means actuates at a predetermined pressure to relieve pressure in the syringe chamber~
A further feature of the invention is that the syringe assembly may provide means for indicating when the prede~ermined amount of pressuxe has been attained.
Still another feature of the invention is that in one embodiment the l:imiting means is associated with an extension of ~ a ~yxinge barrel defining the syringe chamber.
; A feature of the invention is that in one embodimentthe lLmiting means is associated with an adapter for the syringe.
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~a~751~;
Yet another feature of the invention is that in one - embodiment the limiting means prevents movement o~ the plunger into the syringe chamber when the predetermined amount of pres-sure has been attained.
A further feature of the present invention is the provi-sion o~ a method for performing an epidural and a spinal anesthesia ' pxocedure.
Further features will become more fully apparent in the following description of the embodiments of this invention and from the appended claims.
DESCRIPTION OF THE DR~WINGS
In the drawings:
Fig~ 1 is a sectional view of one embodiment of the syr-inge assembly of the present invention as attached to a hollow needle;
Fig. 2 is a ~ragmentary sectional view o pressure limit-ing means in the syxinge assembly of Fig. 1 as actuated above a :, .
~ ~ predetermined pressure;
,:
Fig. 3 is a fragmentary elevational view of the syringe~, 20 assembly of Fig. l;
Fig. 4 is a fragmentary sectional view of another embodi-ment of the syringe assembly of the present invention as being applied to a catheter;
Fig. 5 is a sectional view of an adap~er in another embodiment of the syringe assembly of the present invention:
Fig. 6 is a sectional view of an adapter in another embodiment of the syringe assembly of the presen~ invention;
~ Flg. 7 is a sectional view taken subs~an~ially as indi--` cated along the line 7-7 of Fig. 6;
., .
~ Fig. 8 is a sectional view Qf the adapter of F~g. 7 illustrating pressure limiting means as actuated above a pre-determined pressure;
~75~6 Fig. 9 is a sectional view of an adapter in another embodiment of the syringe assembly of the present inventi,on;
Fig. 10 is a sectional view of the adapter of Fig, 9 illustrating valve means in the adapter as actuated above a p~-determined pressure;
, Fig. 11 is a sectional view taken substantially as indicated along the line 11-]1 of Fig. 9;
Fig. 12 is a sectional view of another embodiment of a syringe assembly of the present invention;
Flg. L3 is a sectional view of another embodiment of a syringe assembly of the present invention;
Fig. 14 is a sectional view of an adapter in another embodiment of the syringe assembly, of the present inventi,on;
Fig. 15 is a fragmentary elevational view of another embodiment of a syringe assembly of the present invention;
Fig. 16 is a fragmentary sectional view of the syringe assembly of Fig. 15;
Fig. 17 is a front plan view of another embodiment of a syringe assembly of the present invention;
Fig. 18 is a fragmentary sectional view taken substan-tially as indicated along the line 18-18 of Fig. 17; and ' Figs. 19 and 20 are fragmentary sectional views of additional embodiments of a syringe assembly of the present inven-~; tion. ' :`' DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to Figs. 1-3, there is shown a syringe assembly or syringe means generally designated 20 comprising a syringe 22. The syringe 22 has a hollow harrel 24 having a cham-' _4_ ~C~7S~
ber 26 for retaining fluid. The syringe also has a plunger 28 having a flexible plug 30 adjacent one end 32 of the plunger received in one end of the chamber 26. The pluy 30 ~ealingly enyages against the inner surface 33 of the syringe barrel 24, with the plunger being pushed into the chamber 26 to purnp fluid out of the chamber.
The syrinye 22 has an extension or extension means 3 projecting from an end of the barrel 24 remote the plunyer 28, with the extension 34 having a tip 36 receivable in the hub H of a hollow needle N. Of course, the tip 36 of the syringe exten-sion 34 may be connected to any other suitable device, ~uch as a catheter, as described below. The extension 34 has a passageway 38 which communicates with the syringe chamber 26 and the hollow needle N, when attached, and has a flexible balloon 40 which communicates with the passageway 38 through an opening 42 in the wall of the extension 34. The balloon 40 comprises a flexible sleeve which surrounds the extension 34, and has a pair of edges 44a and 44b secured to the outer surface of the extension 34 by suitable means 46a and 46b, such as adhesive. Thus, the balloon or sleeve 40 has its edges 44a and b sealed peripherally around the extension 34, such that it defines a cavity 48 int~rmediate the sleeve and the outer surface of the extension 34 which commu-nicates through the opening 42 with the passageway 38.
The balloon 40 is constructed to inflate when a prede-termined pressure has been reached in the passageway or chamber ofthe syringe, the particular pressure at which the balloon inflates being selected for the particular use contemplated for the syringe ; assembly. The pressure at which the balloon inflates may be con-trolled by a number of factors including the particular material 1 ~ .
.: :
.
~7s~
.: I
used for the balloon, such as latex, and the thickness, durometer, and elasticity vf the balloon, as well as the transverse and longi-tudinal radii of the balloon, acco:rding to the law of Laplace which holds that the pressure required to inflate a balloon i5 direct.ionally proportional to its tangential tension and inv~rsely ~ proportional to its transverse and lonyitudinal radii.
In use of the syr.inye for a spinal ~nesthe.sia proceduxe, the chamber is filled with fluid, such as an anesthetic solution, and the syringe tip 36 is attached to the hub H of the needle N, after which the tip T of the needle may be advanced through the tissue t, the potential epidural space e, and the dura mater d of the patientls body, and inserted into the sub dural space s adja-cent the spinal cord s'. The anesthetic solution is then ejected from the syringe chamber 26 into the sub dural space s by pushing the plunger 28 into the syringe chamber. Since the sub dural space is essentially an inelastic blind pouch filled with fluid, as shown in Fig. 1, and under a positive pressure, the balloon 40 of the syringe is selected to inflate at a predetermined pressure greater than the pressure in the sub dural space s. Consequently, as the solution is pumped into the sub dural space, the pressure builds up in the space until it reaches the predetermined pressure, after which the balloon 40 inflates, as shown in Fig. 2, and ~, relieves pressure build up in the space, thus preventing harm to ; the patient. Accordingly, the balloon 40 serves to limit the amount of pressure ~enerated by the syringe, and prevents ejection ~ -.
of further fluid into the needle N and sub dural space a~ter the predetermined pressure has been attained. The inflated balloon also serves as an indication to the user that the predetermined amount of pressure in the space or cavity has been reached, and ,:
.. . . . . . .
107SllG
that the plunger should not be pushed further into the syringe chamber 26.
Another embodiment of the syringe assembly 20 of the present invention is illustrated in Fig. 4, in which like refer-ence numerals designate like parts. In this em~odiment, the exten-sion means 34 includes an adapter 50. If desired, a conventional syringe 22 may be used having a standard luer tip 36'. The adapter 50 has a tip 36 adjacent one end for connection to a catheter C', or other suitable device, such as the needle N, and a recess 52 adjacent the other end o the adapter for attachment to the tip 36' , of the syringe 22. A passageway 38 extends longitudinally through the adapter 50, and communicates between the syringe chamber 26 and the catheter C' when the ends of the adapter are connected to the syringe and ca-theter. The adapter 50 has a flexible sleeve or bal-loon 40 extending around the adapter and having its ends 44a and bsecured peripherally around the outer surface of the adapter by suitable means 46a and b, such as adhesive. The sleeve 40 defines a cavity 48 intermediate the sleeve and the outer surface of the adapter 50 which communicates with the passageway 38 through the opening 42.
In use, after the syringe has been filled with fluid, the adapter 50 is attached to the tip 36' of the syringe 22, and the tip 36 of the adapter 50 is attached to the catheter C'. The catheter may be of a type having a lumen L which communicates between a proximal end P of the catheter and a cavity C'' underly-ing a balloon B adjacent a distal end D of the catheter. For a cardiovascular catheter, as shown, the catheter is previously threaded through a vessel, and the balloon B is inflated through '`.t '' ' ' ' ,' '. ' . ,, ., . ' . .. '. ' :' ' ' ~'75~6 the lumen L by pumping fluid from the syringe chamber 26. When the partially inflated balloon B becomes obstructed by the wall of the vessel, and a predetermined amount of pressure is developed in the cavity C'' defined by the balloon B, the flexible sleeve 40 inflates to limit the amount of pressure generated by the syringe and pxevent overinflation of the balloon B, which otherwise might rupture the vessel.
It i~ apparent that-the pressure limiting or indicating ; means associated with the syringe assembly of the present inven-tion may be incorporated di~ectly onto the syringe itsel~, as previously described, or may be placed on the adapter which is connected to the syringe. In either case, the device operates in a similar manner to prevent harm to the patient. Thus~ for pur-poses of previous and future discussion, it is immaterial whether . 15 the limiting or indicating means is associated with the adapter or the syringe itself.in the syringe assembly, with the exception of the devlces described in connection with Figs. 12 and 13.
Another embodiment of the adapter 50 in the syringe assembly 20 is illustrated in Fig~ 5, in which like reference numerals designate like parts. In this embodiment, the adapter ;: 50 includes an outwardly extending thumb 56 having a channel 58 ; communicating with the passageway 38. The adapter 50 has a flex~
ible sleeve 40 extending peripherally around the thumb 56 and having its edges 44a and b secured peripherally around the thumb by means 46a and b, such as adhesive/ thus defining a cavity 48 communicating with the channel 58 and passageway 38 through the opening 42. The sleeve or balloon 40 inflates, as previously . described in connection with the syringe assembly of Figs. 1-4, .
~ ~ . -8-7S~6 to limit the amount of pressure generated in the passageway 3fl and the syringe chamber.
A further embodiment of the adapter 50 in the syringe assembly 20 of the present invention is i]lustrated in Fic3s. 6-8, in which like reference numerals designate like parts. In this embodiment, a balloon 40' has its peripheral edges 44' sealed by suitable means 46', such as adhesive, to an outer surface 60 of the adapter 50 to define the cavity 4~, which communicates with the passageway through the opening 42. As shown in Fig. 8, the balloon 40' inflates at a predetermined pressure, as previously described, to limit the amount of pressure generated by the ; syringe assembly.
Another embodiment of the adapter 50 in the syringe assembly 20 of the present invention is illustrated in Figs. 9-11, in which like reference numerals designate like part.s. In this -embodiment, a valve element 64 is supported in a chamber 66, with a head 67 of the valve element 64 having a face 68 for sealing against a seat 70 in the chamber 66. The head 67 has a stem 72 extending from an end of the head remote the face 68, with the stem 72 being received in a cavity 74 in the adapter 50. A heli-cal spring 76 surrounds the stems 72 and extends between a back ~, surface 78 of the cavity 74 and a back surface 80 of the head 67.
The adapter 50 has a channel 82 communicating between the passage-way 38 and the chamber 66 adjacent the seat 70, and a pair of channels 84a and 84b communicating between the chamber 66 and an outer surface 86 of the adapter 50. As illustrated in Fig. 9, .
the spring 76 biases the head 67 of the valve elemen~ to a first ~ position with the face 68 sealing agains~ the seat 70 to prevent : . ' 9_ , . . . . .. . .
~[)'7~
passage of fluid from the channel 82 into the chamber 66. How~
ever, when a predetermined amount of presxure is reached in the passageway 38, the spring 74 permits movement of the valve ele-ment to a second position with the face 68 of the head 67 spaced from the seat 70, as shown in Fig. 10, and fluid then passes from the passageway 38 through the channel 8~, chamber 66, and the channels 84a and b to the outer surface 86 of the adapter 50, as indicated by the direction of the arrows in the dra~ing. Thus, the-valve means is actuated a~ a predetermined pressure to relieve pressure in the passageway 38, and limit the amOunt of pressure generated by the syring,e assembly. The pressure a~
, which the valve means is actuated may be selected by the particu-lar structure of the valve assembly, such as the particular heli-,' cal spring 74 utilized in the adapter 50.
lS , Another embodiment of the syringe assembly 20 oE the present invention is illustrated in Fig. 14, in which like refer-ence numerals designate like parts. In this embodiment, the adapter 50 has an outer transparent cylindrical shield 51 defin-, ing a chamber 53, and a pair of extensions 55a and 55b extending into the chamber 53 and partially defining the passageway 38'~
The tubular sleeve 40 has its ends received on the extensions ' 55a and b and secured in place by suitable means 46a and b, such as adhesive. The sleeve 40 ~xpands to limit the amount of pres-sure generated by the syringe assembly, as previously describe~, and is visible to the user through the transparent shield to ~, determine when the sleeve has expanded. The shield serves to protect the sleeve, and air is permitted to pass from the cham-ber 53 through a vent 57 in the shield to permit expansion of '~ the sleeve.
~ ':
,~ -10-' ~L~7S~
Another embodiment of the syringe assembly 20 of the present invention is illustrated in Figs. 15 and 16, in which like reference numerals designate like parts. In this embodiment, the flexible balloon or sleeve 40 extends around the syringe bar-rel 24. The slee~e 40 is secured to an outer surface 152 of the syringe 22 by suitable means 46a and b, such as adhesive, adja-cent the edges 44a and b of the sleeve 40, in order to define a cavity 4B intermediate the sleeve 40 and barrel 24 which communi-cates with the syringe chamber 26 through an opening 42 in the barrel 24~ The sleeve 40 inflates above a predetermined pressure, as pre~iously described, to limit the amount of pressure generated by the syringe.
Another embodiment of the s~ringe assembly of the pres-ent invention is illustrated in Figs. 17 and 18, in which like reference numerals designate like parts. In this embodiment, a balloon 40' has its peripheral edges 44' sealed by suitable means 46', such as adhesive, to the outer surface 152 of the syringe 22 to define the cavity 48, which col~nunicates with the chamber 26 through the opening 42. The balloon 40' inflates at a predeter-mined pressure, as previously described to limit the amount of pressure generated by the syringe.
Another embodiment of the syringe assembly 20 of the present inven~ion is illustrated in Fig. 19, in which like refer-ence numérals designate like parts. In this embodiment, the extensions 34 described in connection with Figs. 4-14 may be permanently affixed to the syringe tip 36' by suitable means 150, such as adhesiveO As shown in Fig. 20, the extensions 34 may be constructed as an integral part of the syringe 22, if desired.
- ' -11-:,. .
, 'Sl~Lt;
Another embodiment of the syringe assembly of the pres-ent invention is illustxated in ~ig. 12, in which like reference numerals designate like parts. In this embodiment, the barrel 24 of the syringe 22 is transparent, and the plunger 28 has a flexible plug 30 adjacent the one plunger end 32 which is received in the syringe chamber 26. The one end 32 of the plunger 28 includes a cent.rally located transparent member 90 having a cavity 92 facing the syringe chamber 26, with ,the tr~ns- ;
parent member 90 being visible through the-barrel 24. A flexible diaphraym 94 is supported by the .plug 30 a;nd extends across an opening 96 intermediate the caviky 92 in the transparent member 90 and the syringe chamber 26. When a predetermined pressure has been attained in the syringe chamber 26, the diaphragm 94 Elexes from a first position adjacent the opening 96, as shown by solid lines in the.drawing, to a second position received in the transparent member 90,,as shown by dotted lines in the'drawing.
The diaphragm 94 is thus ~isible to the user in its second posi-tion and serves as an indication that the predetermined amount of pressuxe has been reached in the syringe chamber., and that , 20 the user should cease pumping the syringe.
A further smbodiment of the syringe assembly of the present invention is illustrated in Fig. 13, in which like refer-ence numerals designate like parts. In this embodiment, the plunger 28 has a flexible plug 30'. adjacent the one plunger end 32'which seals against the inner surface 33 of the barrel 24.
The plug 30' has a:n annular slot 100 having one end 102 communi-cating wlth the syr'inge cavity 26, and defining an annular flex~
ible side wall 104 of the plug 30' adjacent the inner surface 33' . of ~he s.yringe barrel 24. The side wall 104 of the plug 30' flexes responsive to a predetermined pressurs in the syrings 12- ' ,. . , ~ .
75~
chamber 26, and engages against the inner surface 33 of the syr-inge barrel 24 to impede movement of the plunger into the syringe chamber. Thus, when ~he predetermined amount of pressure is yen-erated by the syringe, resistance to movement of the syringe plunger 28 into the syringe barrel 24 becomes noticeable to the user, and movement o the plunger is then stopped to prevent dam-age to the patient.
Thus, there has been described a syringe assembly which has means for limiting the amount o~ pressure generated by the syringe as~embly to prevent harm to a patient. In addition, the syringe assembly indicates to the user when the predetermined amount of pressure has been reached.
According to the present invention, methods are also pro-vided for performing an epidural and a spinal anesthesia procedure.
In a spinal anesthesia procedure, the tip of a needle, u~ed to per-form the pxocedure, is advanced through the body tissue t, the epidural space e, which is at a slight negative pressure, and the dura mater d into the sub dural space s, which is at a positive pressure, a~ previously described in co~nection with Fig. 1.
According ~o a method o~ the present invention, a balloon of the adapter in the syri~ge assembly is selected to inflate at a first predetermined pressure less than the pressure in the s~b dural space, and a balloon on the syringe, which is removably attached to the adapter, is selected to inflate at a second predetermined pressure greater than the pressure in the sub dural space When the needle tip T pierces the dura mater d and enters the sub dural space s, fluid in the space actuates the balloon on the adapter due to the higher pressure in the space relative the first pre-determined pressure, thus indicating that the needle tip is at the proper location in the space for performing the spinal anesthesia :
.. .. . . .~ . .
lQ~S~L~L6 procedure. The adapter may be removed from the needle and syringe, and the syringe is attached to the needle to eject anesthetic solu-tion into the sub dural space. The balloon on the syringe limits the amoun~ of pressure generated by the syringe to prevent harm to the patient, as previously described.
Alternatively, fixst and second adapter~ may be used in conjunction with a standard s~ringe, the first adapter having a balloon inflatable at the first predetermined pressure, an~ the second adapter having a balloon inflatable at the second predeter-mined pressure. The ~alloon of the first adapter is utilized to determine when the needle tip is located in the sub duxal space, after which the first adapter is replaced with the second adapter for pumping the anesthe~ic solution into the space.
A method is also provided for performing an epidural anesthesia procedure with the syringe assembly of the present inven-tion. After the tip of a needle, attached to a syringe or an adap-ter and syringe, is advanced into the ~ody tissue, the syringe plunger is pushed sufficiently into the syringe chamber to inflate a balloon on the syringe assembly with anesthetic solution from the chamber. The needle tip is then advanced toward the epidural space. When the needle ~ip enters the epidural space the solution from the ~yringe assembly flows into the space due to the pressure generated ~y the inflated balloon relative the negative pressure in the space. Thus, the balloon deflate~ and indicates to the user that the needle tip is properly located for performing the proce-dure. ~he anesthetic solution may then be eject~d from the syringe into the epidural space. Accordingly, the method of the invention prevents the user from improperly puncturing the duxa mater during the epidural anesthesia procedure.
~ The foregoing detailed description is given for clear-1~7~
ness of understanding only, and no unnecessary l.imitations should be understood therefrom, as modifications will be ob~ious to those skilled in the art.
!
J
-15- .
' .'"' " .'' - ', " . ' ' ~ '' ' ' ' ,' ' : ' . ' ., ' ' ' .
Claims (3)
1. A syringe, comprising:
a barrel having a chamber for retaining fluid, and opening means communicating between the chamber and the out-side of the barrel;
a tip for attachment to a fluid receiving device;
a plunger having one end received in the chamber for pumping fluid from the chamber; and a flexible balloon secured to the barrel over said open-ing means and defining a cavity communicating with fluid in the chamber through the opening means, said balloon inflating above a predetermined pressure to relieve pressure generated by the syringe.
a barrel having a chamber for retaining fluid, and opening means communicating between the chamber and the out-side of the barrel;
a tip for attachment to a fluid receiving device;
a plunger having one end received in the chamber for pumping fluid from the chamber; and a flexible balloon secured to the barrel over said open-ing means and defining a cavity communicating with fluid in the chamber through the opening means, said balloon inflating above a predetermined pressure to relieve pressure generated by the syringe.
2. The syringe of Claim 1 wherein said balloon com-prises a flexible generally cylindrical sleeve surrounding the barrel, said sleeve having a pair of edges secured to said barrel and defining said cavity intermediate said sleeve and the outer surface of the barrel.
3. The syringe of Claim 1 wherein said balloon is secured peripherally around its edges to the outer surface of the barrel, said balloon defining said cavity intermediate the balloon and the outer surface of the barrel.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA338,373A CA1075116A (en) | 1975-11-03 | 1979-10-25 | Syringe assembly |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US05/627,982 US4000741A (en) | 1975-11-03 | 1975-11-03 | Syringe assembly |
| CA260,531A CA1075114A (en) | 1975-11-03 | 1976-09-03 | Syringe assembly |
| CA338,373A CA1075116A (en) | 1975-11-03 | 1979-10-25 | Syringe assembly |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1075116A true CA1075116A (en) | 1980-04-08 |
Family
ID=27164633
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA338,373A Expired CA1075116A (en) | 1975-11-03 | 1979-10-25 | Syringe assembly |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1075116A (en) |
-
1979
- 1979-10-25 CA CA338,373A patent/CA1075116A/en not_active Expired
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |