CA2134547C - Catheterization system - Google Patents
Catheterization systemInfo
- Publication number
- CA2134547C CA2134547C CA002134547A CA2134547A CA2134547C CA 2134547 C CA2134547 C CA 2134547C CA 002134547 A CA002134547 A CA 002134547A CA 2134547 A CA2134547 A CA 2134547A CA 2134547 C CA2134547 C CA 2134547C
- Authority
- CA
- Canada
- Prior art keywords
- needle
- catheter
- guide wire
- flashback
- blood
- 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 - Lifetime
Links
Classifications
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0693—Flashback chambers
-
- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
Abstract
A catheterization system (10) to allow the user to quickly visualize the flashback of blood after penetration of a blood vessel. The system (10) allows for minimum blood loss during initial penetration of the vessel. The invention is directed to a system (10) for introducing an over-the-needle catheter with an inserter unit (12) having a hollow needle (14) and a catheter (92) wherein the catheter (92) and the needle (14) cooperate to form a first flashback chamber therebetween. The first flashback chamber is partially translucent and allows for the visualization of blood flow upon insertion of the needle (14) into the vessel. A guide wire (16) is dimensioned in relation to the needle (14) to provide a blood flow passage therebetween. A second flashback chamber (22) is formed in the inserter unit (12) and connected to the needle (14) to receive blood flow therefrom.
Description
j~ ~'0 93~:252~;3 2 1 3 1 S ~ 7 PCT'/US93/OS84~ "
.
CATHETER I ZAT I ON SYSTEM
~', 1. Field of the Invention :
; This invention relates to improved catheterization systems and, more particularly~ to a compact and ~loodless system for introducing an over-the-needle catheter into a blood vessel utilizin~ a wire guide.
.
CATHETER I ZAT I ON SYSTEM
~', 1. Field of the Invention :
; This invention relates to improved catheterization systems and, more particularly~ to a compact and ~loodless system for introducing an over-the-needle catheter into a blood vessel utilizin~ a wire guide.
2. Backqround of the Invention Over the years, many systems have been used for introducing a catheter into a blood vessel using a wire to guide the catheter into the vessel. One system involves the use of a hollow introducer needle having an over-the-needle catheter mountèd thereon. After the bevelled tip of the introducer needle is inserted into the blood vessel, as indicated by "flashback" ~i.e., the ; ~low of blood from the punctured vessel through t~e hollow needle and out the proximal end thereof), a wire guide is fed through the hollow introducer needle and advanced until the desired length of the wire guide is within the blood vessel. The catheter is then advanced off o~ the introducer needle onto the wire guide and into the blood vessel.
Another system is shown in U.S. Patent No.
4,~17,886 entitled "Catheter Introduction Set". ("the ,~
'886 Patent"), which discloses a catheter introduction set for the introduction of an over-the-needle catheter into a relatively small diameter blood vessel. The set includes a hollow needle, an over-the-needle catheter, S and a wire guide with the needle and wire guide contained in a slngle unit. The catheter is carried on the holIow needle and the wire~guide is'located within the hollow needle. After puncturlng t~he vessel usiny the needle, blood flashback is visualized in the clear hub of the introducer needle (to provide a positlve indication that the needle ~is actually within the vessel) and the wire guide ls then advanced through the hollow needle and in;to~ the blood vessel. The over-the-needle catheter 1S then advanced off of the ~'~15 ~needle,~ onto the wire gulde and into the~ vessel, after which the inserter unit (the introducer needle and ~he wire 'guide~ is remoYed ~from the inserted catheter and may;~be thr~own away. The placed catheter 1s~ connected to a stop cock, injection cap or to~an appropriate connecting tubing. Although the ~set described in the ;'88,6~Fa~tent has en~oyed success, aspects the~reof require improvement, particularly with respect to the size o~
the;~ system,~ the~ desirability ~ of~ instantaneously visuali~zing fla~shbac~ and the~ever~i~ncreasing ;~
25~ ;requirement~ of~ dèvelopi~ng~ patient~ ca~re ~systems whlch~
minimize~ contact;~by~ healthc~are worker's~ with patient~
flùi~ds~including,~princlpal~ly, blood.
. W093/25253 2 1 ~ 4 5 ~ 7 PCT/US93~05~9 .
-~ !
--3-- .
~ catheterization system which exhibits some of the advantages of the '886 Patent is shown in ~.S.
Patent No. 4~899,05~ of January 16, 1990 entitled "Flash Detection In An Over~The-Needle Catheter With A
Restricted Needle Bore" ("the '052 Patent"). In the '052 Patent, a translucent over-the-needle catheter is mounted over an introducer needle having a bevelled tip. The distal end o~ the catheter is provided with a tight ~it with the distal end of the needle, while th~
inside diameter of the catheter is dimensioned ln relation to the outside diameter :of the needle to provide an annular flashback chamber therebetween, which chamber is closed at its distal end and open at its proximal end.
15The hollow needle is connected to the annular : flashback chamber by an access port formed in the needle near the distal tip o~ the catheter such that, upon penetration of the vessel by the~ needlQ, there will be rapid visua1ization of flashback of blood into the annular flashback chamber. To facilitate the insertion ~f I the catheter into the vessel, ;a guide wire is positioned within the hollow needle. ~After flashback . . .
blood ent~rs the annular flashback chamber via the : access port, the wire guide is advanced into the vessel and the over-the-need]e~ca~heter :is then moved of~ the needle and along the guide wire into the blood vessel.
Advancement of the wire gui~de into the vessel serves to 2 1 3 4 r~
W093/25253 ; PCT/US9~05~9 ~ ~
obstruct the access port, thereby limiting the free flow of flashback blood into the annular chamber.
Upon placement of the catheter in the vessel, ~-the inserter unit, which includes the syringe, the introducer needle and the guide wire, is separated from the placed catheter at which point the catheter may be appropriatel~ connected for its intended purpose.
Although early flashback can be visuallzed in this prior art s~stem, there are a number o~ disadvantages including overall size, the need to use a construction much like a hypodermic ~syringe with its comple~ities, etc. :
Still other prior art systems are available for in5erting catheters utilizing wire guide techniques and 15~ pr~viding for ~lashback visualization to permit confirmation o~ the proper placement of the introducer .
needle lnto th~ blood vessel, One such~ system is identified as the Arrow EID Catheter whi h includes a sel~-contained J-spring wire guide which is inser~ted through a thin wall intr~ducer needle ~ to ass1st ~ 1 ! advanlcement and accurate placement of the~ catheter iln ; ~ any central vein. In this system, flashback is vlsualized by the flow of flashback ~blood through the . :' : introducer needle and about the J-shaped spring wire : ~ :
~25 gulde to an aspiration syringe. In the Arrow EID
: Cathe~er, the wire guide is initially in its retracted ~:~ position~. The vessel is punctured by the introducer W0~3/~5253 ~1~4S~ ~ PCTJUS93/05~g ~
. .
s needle, and blood flashback inaicates successful entry into the vein. After stabilization of the introducer needle, the spring wire ~ulde is advanced as required into the vessel and the catheter is moved forward along the spring wire into ~he vessel.
A sign~ficant problem with many prior art deslgns is that the~ are not bloodless. For e~ample, some ~1ashback chambers are designed so that blood within ~he chamber leaks out and may then come in contact with nurses and physicians. Other designs permit blood leakage through the wlre gulde insertion assembly. Still other designs permlt leakage at the needle hub~ As can be readily ascertained by inspection of the prior art systems, there remains a need for a lS compact, bloodless catheterization system which provides an earIy visual indlcation of flashhac~, is readily mass produced, easily packaged and sterillzed and convenient for use preferably in a one-hand operation. In such design, it would be~highly desirable for the user to be able to see the flashback~ as soon as it enters the introducer needle to provide a prompt~ indication of th!e ; proper placement of the lntroducer needle into the ~ ~ ~ , . ....
~;~ vessel as the~;~first step in ~the placement of the over-the-needle catheter lnto the vess~el with the ald of a wire guide.
. ~ ~
213~47 W~93~5253 PCT/US93/05~9 SUMMARY OF THE INVENTION
This invention is directed to a system for introducing an over-the-needle catheter into a blood vessel, the system includes a body and a hollow needle having a proximal end connected to the body. The needle is also formed with a distal needle tip and at least one port close to the needle tip. A catheter having a lumen termi~ating at a distal cathe~er tip is adapted to be carried on the needle and is dimensioned in relation to the needle such that upon placement o~ the catheter over the needle, the cathete~r and the needle cooperate to form a first flashback chamber therebetween. The first chamber is in communication with the interior of the hollow needle, and the catheter is at least partially translucent to enable the visuali~ation of blood flow into the first chamber upon insertion of the needle tip into a blood vessel. A guide wire haYing a distal end I is slidably mounted in the body and within the hollow , . .
needle, and dimensioned ln relation to the needle to provide a blood flo~ passage therebetween. The ~uide wire is mova~le between a first position in which its ; distal end is wholly within the hollow needle, and a second position in~ which the distal end e~tends beyond the needle tip. A sec~ond flashback chamber is ~ormed in the body and connected to the needle to receiYe blood :~ flow upon insertion of the needle tip into a blood vessel.
~: .
Another system is shown in U.S. Patent No.
4,~17,886 entitled "Catheter Introduction Set". ("the ,~
'886 Patent"), which discloses a catheter introduction set for the introduction of an over-the-needle catheter into a relatively small diameter blood vessel. The set includes a hollow needle, an over-the-needle catheter, S and a wire guide with the needle and wire guide contained in a slngle unit. The catheter is carried on the holIow needle and the wire~guide is'located within the hollow needle. After puncturlng t~he vessel usiny the needle, blood flashback is visualized in the clear hub of the introducer needle (to provide a positlve indication that the needle ~is actually within the vessel) and the wire guide ls then advanced through the hollow needle and in;to~ the blood vessel. The over-the-needle catheter 1S then advanced off of the ~'~15 ~needle,~ onto the wire gulde and into the~ vessel, after which the inserter unit (the introducer needle and ~he wire 'guide~ is remoYed ~from the inserted catheter and may;~be thr~own away. The placed catheter 1s~ connected to a stop cock, injection cap or to~an appropriate connecting tubing. Although the ~set described in the ;'88,6~Fa~tent has en~oyed success, aspects the~reof require improvement, particularly with respect to the size o~
the;~ system,~ the~ desirability ~ of~ instantaneously visuali~zing fla~shbac~ and the~ever~i~ncreasing ;~
25~ ;requirement~ of~ dèvelopi~ng~ patient~ ca~re ~systems whlch~
minimize~ contact;~by~ healthc~are worker's~ with patient~
flùi~ds~including,~princlpal~ly, blood.
. W093/25253 2 1 ~ 4 5 ~ 7 PCT/US93~05~9 .
-~ !
--3-- .
~ catheterization system which exhibits some of the advantages of the '886 Patent is shown in ~.S.
Patent No. 4~899,05~ of January 16, 1990 entitled "Flash Detection In An Over~The-Needle Catheter With A
Restricted Needle Bore" ("the '052 Patent"). In the '052 Patent, a translucent over-the-needle catheter is mounted over an introducer needle having a bevelled tip. The distal end o~ the catheter is provided with a tight ~it with the distal end of the needle, while th~
inside diameter of the catheter is dimensioned ln relation to the outside diameter :of the needle to provide an annular flashback chamber therebetween, which chamber is closed at its distal end and open at its proximal end.
15The hollow needle is connected to the annular : flashback chamber by an access port formed in the needle near the distal tip o~ the catheter such that, upon penetration of the vessel by the~ needlQ, there will be rapid visua1ization of flashback of blood into the annular flashback chamber. To facilitate the insertion ~f I the catheter into the vessel, ;a guide wire is positioned within the hollow needle. ~After flashback . . .
blood ent~rs the annular flashback chamber via the : access port, the wire guide is advanced into the vessel and the over-the-need]e~ca~heter :is then moved of~ the needle and along the guide wire into the blood vessel.
Advancement of the wire gui~de into the vessel serves to 2 1 3 4 r~
W093/25253 ; PCT/US9~05~9 ~ ~
obstruct the access port, thereby limiting the free flow of flashback blood into the annular chamber.
Upon placement of the catheter in the vessel, ~-the inserter unit, which includes the syringe, the introducer needle and the guide wire, is separated from the placed catheter at which point the catheter may be appropriatel~ connected for its intended purpose.
Although early flashback can be visuallzed in this prior art s~stem, there are a number o~ disadvantages including overall size, the need to use a construction much like a hypodermic ~syringe with its comple~ities, etc. :
Still other prior art systems are available for in5erting catheters utilizing wire guide techniques and 15~ pr~viding for ~lashback visualization to permit confirmation o~ the proper placement of the introducer .
needle lnto th~ blood vessel, One such~ system is identified as the Arrow EID Catheter whi h includes a sel~-contained J-spring wire guide which is inser~ted through a thin wall intr~ducer needle ~ to ass1st ~ 1 ! advanlcement and accurate placement of the~ catheter iln ; ~ any central vein. In this system, flashback is vlsualized by the flow of flashback ~blood through the . :' : introducer needle and about the J-shaped spring wire : ~ :
~25 gulde to an aspiration syringe. In the Arrow EID
: Cathe~er, the wire guide is initially in its retracted ~:~ position~. The vessel is punctured by the introducer W0~3/~5253 ~1~4S~ ~ PCTJUS93/05~g ~
. .
s needle, and blood flashback inaicates successful entry into the vein. After stabilization of the introducer needle, the spring wire ~ulde is advanced as required into the vessel and the catheter is moved forward along the spring wire into ~he vessel.
A sign~ficant problem with many prior art deslgns is that the~ are not bloodless. For e~ample, some ~1ashback chambers are designed so that blood within ~he chamber leaks out and may then come in contact with nurses and physicians. Other designs permit blood leakage through the wlre gulde insertion assembly. Still other designs permlt leakage at the needle hub~ As can be readily ascertained by inspection of the prior art systems, there remains a need for a lS compact, bloodless catheterization system which provides an earIy visual indlcation of flashhac~, is readily mass produced, easily packaged and sterillzed and convenient for use preferably in a one-hand operation. In such design, it would be~highly desirable for the user to be able to see the flashback~ as soon as it enters the introducer needle to provide a prompt~ indication of th!e ; proper placement of the lntroducer needle into the ~ ~ ~ , . ....
~;~ vessel as the~;~first step in ~the placement of the over-the-needle catheter lnto the vess~el with the ald of a wire guide.
. ~ ~
213~47 W~93~5253 PCT/US93/05~9 SUMMARY OF THE INVENTION
This invention is directed to a system for introducing an over-the-needle catheter into a blood vessel, the system includes a body and a hollow needle having a proximal end connected to the body. The needle is also formed with a distal needle tip and at least one port close to the needle tip. A catheter having a lumen termi~ating at a distal cathe~er tip is adapted to be carried on the needle and is dimensioned in relation to the needle such that upon placement o~ the catheter over the needle, the cathete~r and the needle cooperate to form a first flashback chamber therebetween. The first chamber is in communication with the interior of the hollow needle, and the catheter is at least partially translucent to enable the visuali~ation of blood flow into the first chamber upon insertion of the needle tip into a blood vessel. A guide wire haYing a distal end I is slidably mounted in the body and within the hollow , . .
needle, and dimensioned ln relation to the needle to provide a blood flo~ passage therebetween. The ~uide wire is mova~le between a first position in which its ; distal end is wholly within the hollow needle, and a second position in~ which the distal end e~tends beyond the needle tip. A sec~ond flashback chamber is ~ormed in the body and connected to the needle to receiYe blood :~ flow upon insertion of the needle tip into a blood vessel.
~: .
3 2 1 3 4 5 'I 7 PCl'/US93/05849 '~
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects, features and advantages of the present invention will be understood from the following detailed description of a preferred embodiment of the present invention, when taken in conjunction with the accompan~ing drawings wherein:
FIG. 1 is an enlarged, exploded perspective view of a preferred embodiment of the catheterization system of the present invention with the catheter being separated from the inserter unit and with the catheter shown being pinched off to prevent blood flow through the catheter (e.g., after placement ln the blood vessel) and with typical finger positions shown on the inserter unit for one-handed manipulation thereof;
FIG. 2 is a top view of the catheterization system showing the inserter unit and the catheter mounted thereon;
FIG. 3 is a side yiew of the catheterization system shown in FIG. 2 showing the introducer needle in the bevel-up posi~ion and with the guide wire actuatin~
leverl in its~ fully~ retracted position at the proximal end o~ the 1nser~er un1t;
: FI5. 4 is a partial sectional view taken along the lines 4-4 of FIG. 3 and showing details of the internal construction of the lnserter unit including the guide wire and its actuator which are shown in the retracted position :~ .
W093/25253 2 1 3 4 ~ ~1 7 pCT/US93/05~9 ~ ~ ~
FIG. 5 is an enlarged sectional view taken along the lines 5-5 of FIG. 4 and showing the pro~imal end of the inserter unit including the actuator for the wire guide, the detent mechanisms for retaining the wire guide actuator in the retracted position and the flashback chambers;
FIGS. 6A-6D is a series of partial sectional views showing, ~rom top to bottom, the wire guide (FIG.
6~), the body of the inserter unit (FIG. 6B), the introducer needle assembly showing the multiple blood flashback ports in the needle body (FIG. 6C), and the catheter assembly including the catheter body and catheter hub (FIG. 6D);
FIG. 7 is an enlarged section of the area circled in FIG. 4 showi~g details of the permanent connection between the needle hub and the body of the inserter unit and illustrating, by stippling, the blood flow paths from the cavity of the needle hub to the two separate main f1ashhack chambers;
FIG. 8A is an enlarged section of the area circl~d in FIG. 4 (and to the rigllt of the enlargement shown in FIG. 7) showing the releasable conn~ction between the needle hub of the inserter unit and the . .-.-catheter hub;
; 25. FIG. 8B is an enlarged section of the area circled in FI~. 4 (and to the right of t~e enlargement shown in FI~. ~A) showing the details of the W093/25253 21 3 4 5 ~ 7 PCT/US93/05~9 _9_ relationship between the introducer needle, the catheter and the wire guide at the distal ends thereof and illustrating, in particular, the flow of blood by stippling from the bevelled needle tip through the bore o~ the needle and through a needle flashback port into the annular flashback chamber formed between the interior of the catheter and the exterior of the needle;
FIG. 9 is a sectional view:taken along the lines 9-9 of FIG. 8B and showing the relationship between the concentric guide wire, needle and- catheter and showing the shape of the flashback port in the needle and the overall annular shape of the annular flashback chamber;
and FIG. 10 is a sectional view taken along the line 1510- 10 of FIG. 8B at the location where the lumen of the catheter makes physical contact with~the outer diameter of the needle to preclude leakage o~ blood from the distal end of the annular flashbac~ chamber.
:
DESCRIPTION OF THE PREFERRED~EMBODI~ENTS
~, ~20! ~ I ,FIG. 1 shows the catheterization system 10 wit~
its two major components (the ~inserter unit 12 and catheter assembly 18j separated f~ro~m one another for purposes of illustration. The insert~r unit 12 ~which is pre~erably disposable~ after :use) is made up of a neèdl~e a~ssembly 14:, a guide ~wire 16 having an actuator 20 connect~d'to the pro2imal end thereo~ and a body 22.
"' :' W0~3/~5253 2 1 ~ ~ ~ 1 7 ; PCTtUSg3/05~9 1 ....... . .
The needle assembly 14 is connected to the body 22,w~ich body 22 also carries the actuator 20 of the guide wire 16. The actuator 20 is mo~able along the length of the hody 22 ~o advance the guide wire 16 from its normal retracted position to an e~tended position as described in detail hereinbelow. The actuating lever 20 is located such that it may be manipulated by the thumb Fl of the person placing the catheter while the inserter unit 12 is grasped between the forefinger F2 and index finger F3 thereby facilitating one-handed operation of the system lO. Further, there is illustrated a finger F4 placed on the fle~ible portion of the catheter assembly 18 for the purposes of pinching off blood flow (after the catheter assembly 18 has heen inserted into a lS vessel) to enable attachment of an appropriate stop cock or the like.
Prior to use, the catheterization system lO is in the assembled position shown in FIGS~ 2-4, inclusive, in which the inserter unit l2 removably carries the catheter assembly 18 on the needle assembly 14 in an .l ove~r-~he-needle position. FIGS. 2-4 show the actuatojr Z0 in its normal retracted position at the proximal end of the inserter un1t l2. In this retracted position, the distal end of the ~uide wire 16 is located within ?.5 the needle assembly 14: as shown in FIG. 8B. The needle assembly 14 ~5 0~ a length in relation to the catheter assembly 18 such that when the catheter assem~ly 18 is .. W~93/25253 2 1 3 ~ ~ ~1 7 ' PCT/US93/05~9 ..
on the needle assembly 14 the distal end of the needle assembly 1~ (shown to the right in FIGS. 2-4 ~ 8B) extends be~ond the distal end of the catheter assembly 18.
The catheterization system 10 is constructed from four basic parts which are separately shown in FIGS. 6~-6D prior to assembly o~ the s~stem 10. FIG. 6 shows the guide wire 16 and its actuator 20. The proximal end 16a o~ the guide wire 16 is physically attached to the actuator 20 while the distal end 16b is formed with a rounded (e.g., semi-spherical) tip (See FIG. 8B). FIG. 6B shows the body 22 of the inserter unit 12 which body receives the guide wire 16 and sl1dably carries its actuator 2~. Body 22 is connected to the.needle assembly 14, as shown in F.IG. 6C. The needle assembly 14, in turn, carries the over-the-needle catheter assembly 18 shown in FIG. 6D.
The body 22, shown in the enla~rged cross-section ~; of FIG. 5, includes spaced side walls~29, 2~ which, ~or convenience and ease of handling are slightly rounded or , l outwardl~ bowed (see:FIGS. 1 and 5),:,an interconnecting top wall 28 which has a medial and longitudinally e~tending slot 30 and an interconnecting bottom~ wall 32. Additionally, the body 22 is formed with internal dividing w~lls 34, 36 which are appropriately shaped to orm two spaced channels 38, 40; which cons~itute the : :: :
~ second or:main flashback chamber located within the unit . ~ ~
.
W093/25253 2 1 3 4 ~ '~ 7 PCT/US93/05~9 .. ... ..
body 22. Specifically, the walls 24, 34 and the contiguous portions of the ~alls 28, 32 form the elongated channel 38 e~ten~ing along side wall 24 and visible there~hrough, with the channel 40 being S similarly ~vrmed and likewise being visible through its contiguous external wall 26. Centrally of the body 22, divider walls 34, 36 are shaped along with the top and bottom walls 2~, 32: to provide a longitudinally e~tending medial track 42 which, as seen in FIG. 5, is open through top wall 28 of the body 22 through slot 3d which is substantially coe~tensive with the track 42.
Re~erring to FIG. 6B, the body 22 has a progimal end 22a and a distal end 22b. Opening throu~h the pro~imal end 22a of the unit body 22 are the spaced open pro~imal ends of the channels 38, 40 designated respe~tively as 38a, 40a, and the pro~imal open end 42a of the track 42. The proximal ends 38a, 40a of the channels 38, 40 are closed against blood flow by porous : plugs 44, 46 which enable the purging of air. At their ~0 distal ends 38b, 40b, the channels 38, 40 co~municate !~,; with ~he internal cavity 5~, created by the pr~ojecting;
wall ~8. Internal cavity 50 receives the proximal end ~ o~ the needle assembly ~14, as will be subsequeintly 'i : described, to complete paths from t~e distal tip 14b of ~the neadle assembly 14 to the pro~imal ends 38b, 40b of the channels 38, :40.
Dlsposed ~etween the distal ends 38b, 40b of the ~ WO93/252~3 ~ S~1 7 ~(~/US93t05849 )~
, .. ~ . ' ~
channels 38, 40 and closing off the distal end 42b of the track 42 is a transverse partition 52 which is formed with a guide wire receiving opening 54 through which the guide wire 16 is passed for longitudinal movement ~elative to the inserter unit 12. The fit between the guide wire 16, which has uniform diameter, and the opening 54 lS such as not to interfere with easy slidin~ movement thereof but, at the same time, to preclude the flow of blood therethrough and into the track 42 (see FIG. 7). As best shown in FIGS. l and 6~, track 42 is open at its proximal end 42a and along its top as a result of the provision of the longitudinally e~tending and medially disposed slot 30 in the top wall 28 of the body 22. The distal or ~oremost circular ~ace lS 52a of the partition 52 will, as will subsequently be described, divert~the flow of flashback blood into the :: contiguous distal ends 38b, ~Ob of the channels 3~, 40.
~ Referring ne~t to FIGS.~ 1-6 and, in particular~~
to FIG. 5, there is illustxated the construction of the 20: guide wire~actuator 2~0 which is used for moving~ the guide! wire 16 with,in the,track 42 th,rough;a relat:ivelly short stroke (e:.g. the length of the track 42). ~Such : : mo~ement of the~ actuator 2Q results in the projection of :
the sphe~ical:distal tip 16b of the guide~wire 16 beyond :,, 25 ~ the distal t~ip:~ 1~4b :of the needle~ assembly 14 and into :the blood vessel~so~that the guide wire~16 can perform :its ~guiding fun~tion. The: :suide wire actuator 2 ~ ~ -W093/25253 2 1 3 ~ S ~ 7 PCT/US93/05~
includes an upstanding actuating lever 56 which projects above the top wall 28 of the body 22 and is in a position which is readily accessible to the user ~see FIG. 1). The guide wire actuator 20 includes laterally extending stabilizing feet 58, 60 which ride along the flat upper sur~ace 28a of the top wall 28 of the body 22. Projecting downwardly from the stabilizin~ feet 58,60 is a connecting web 62 which, in turn, carries a cylindrical slide member 64 which is attached to the proximal end 16a of the guide wire 16 for advancing and retracting the guide wire 16 as a result of the movement of the actuator 20 between limit positions.
Initially, the actuator 20 is disposed in a ~ully retracted position shown in FIGS. 2 and 3 and contiguous to the pro~imal end 22a of the body 22. The actuator 20 is releasably held in this retracted : position by an app~opriate deten~t mechanism 66 located on the connecting web 62 of the actuator 20 and on the upstanding walls of the slot 30. :The detent mechanism 66 may take a variety o~ forms and here includes , outwardly e~tending ~proj,ections formed on the opposite upstanding walls of the connecting web 62 whi~h are ~: : respectively located between paired positioning projections ~ormed on the upst:anding walls o~ the slot , 30 contiguous to the proximal end 22a of the body 22. .' The projections coact with each other to hold the actuator 20 in the retracted position at tAe pro~imal ; .
, ;.
",~, W093/25253 2 1 ~ ~1 S 'I 7 PCT~US93/05~9 ~ ' ., ~
end 22a o~ the inserter unit 12. In this position, the rounded distal tip 16b of the guide wire 16 is proximal of the distal tip 19b of the needle assembly 14 and optimally in a clearance posi~ion wlth respect to the most distal port 70d (see FIG. 8B), so as not to inhibit the proper functioning of the system, particularly with respect to early visualization of flashback.
Upon movement of the actuator ~20 ~from its initial retracted position toward lts extended position, i~e, toward the distal end 22a of the body 22, t~e leading edge of the upstanding actuating lever 56 and .~ .
~: the leadi~g edges of the stabilizing feet 58, 60 will contact an upstanding abutment 68 located on the body 22 (See FIG. l). Such contact limits the movement of the l5~ ;actuator 20 and the correspond1ng amount of extension of ~ ~
: the distal tip 16b of the gulde,wir:e~16 past the distal ~ ~;
'tlp ~14b of the~ needle assembly 19:and ~i.nto the: blood vessel. The entire~sub-assembly of the actuator 20 and : : :
: the guide wire 16 may be w1thdrawn'~(against the~mlnimal~
'2~ re5istance of the detent mechani:sm 66) from the pro~i:mal' end, 4l2a .of thej gu;ldeway 42 so that the guiqe wi~re~,16 and 'actuator 20 ;may be;separated from the sys~tem~lO for~ use indépendently o~ ~the system. ::.: ~
Refer:ence wi~1:1;now be made~to FIG.:~6 in 2~5~ conjunction~with;FIGS. 4~and~7~for~an explanation~of the~
need1~ assembly~;~14:~and~the~manner~in~;wh~ich it is connect~d to the:;~body:~22~
W093/25~53 2 1 ~ 7 pCT/US93/05~9 The needle assembly 14 includes an elongated needle body 70 o~ an appropriate gauge t~pically in the range of 16-24. The needle body 70 is mounted at its pro~imal end 70a on the needle hub 72 and is ~ormed with a bevelled distal tip 70b. The needle body 70 includes a needle bore 70c of uniform cross~section which receives, with appropriate clearance and as will subse~uently be described, the wire guide 16. The operative orientation of the needle body 70 is with the bevel 70b up. Also along the uppermost surface of th;e needle bod~ 70, there are provided a series of flashback blood ports 70d arranged in spaced relation with each other along a length of the needle body 70. The blood ports 70d, along with the catheter assembly 18, provide ; 15 a first flashback chamber. Specifically, the ports 70d in: the needle body 70 are spaced proximally of the bevelled tip 70b to provide an lntermediate section of the needle body 70 which will cooperate with the catheter 18 to provide an early or first flashback '20 chamber, located ~etween the outside wall of the needle bod~ j70 and inside wall of the catheter ~assembly 18l.
The spacing of the most distal port 70d is such that only a relatiYely short path for blood flow exists from . ~-the bevelled distal tip 70b of the needle body 70 2S through the needle bore 70c and into such ~irst of the ~: series of flashback ports 70d.
The needle hub 72:includes a hub body 74 having '': ~................................ ' ~ W093/~5253 213 4 S ~ 7 Pcr/uss3/o~s4~
a pro~imal end 74a and a distal end 74b. At its distal end 74b, the needle body 74 is formed with a male luer slip or cylindrical supporting plug 76 which is sized for releasable but fluid tight (but not air tight) S connection to a female luer lock connector or hub, to be described, on the pr~o~imal end of the catheter assembly 18. Contiguous to its proximal end 74a, the hub body 74 is formed with a male needle mounting hub 78 which is sized to be received within the projecting cylindrical wall 48 of the body 22. The hub body 74 includes a step~80 which is s1zed to: fit into and close : o~~ the cavity 50 in the distal end 22b o~ the body 22, as seen best in FIGS. 4 and 7.
~eferring now to FIGS. 5B, 6C and 7, the hub lS body 74 is provided with an internal cavity 82 which, at : ' :
:~ its distal end, communicates with the needle bore 70c and, at its progimal end, is formed with ports 84, 86.
: whi:ch establish lateral openings at either side of the ; partition 52 of the body 22 such that the flashback : 20 blood diverted by the~surface 52a may flow into ~the ad~acent distal ends 38b, 40b~of the channels 38, 40 (See FIG. 7). In-between the step 80 a~d the ma:le luer sll~p 76:, the needle hub body ~74 lS formed w1th four~
: radially e~tending finger p1eces~88 at 90~
circumferential ' spacings which~ are~ appropriately -.
contour:ed a't:t;heir outermost edges to provide gripping : :
or::finger r~eceiving notches or~ depressions 90 (see, in W093/25253 2 1 3 d~ 5 ~1 ~ PCI /VSg3/05849 r~
particular, FIG. 1). When the hub 72 of the needle assembly 14 is mounted on the di.stal end of the body 22 and permanently attached thereto for e~ample by use of an appropriate adhesive or by sonic welding or the like, it will be seen that a con~inuous path for flashback blood is established from the bevelled tip 70b of the needle body 70 through needle hub cavity 82 and via the ports or windows 84, 86 into the channels 38, 40 formed in the body 22.
As best shown in FIG. 6, the catheter assembly 18 is seen to include a~ elongated catheter body 92 havi~g pro~imal and distal ends 92a, g2b ~nd an internal lumen or bore 92c. The end of the catheter body 92 contiguous to the distal tip 92b is formed with a progressively decreasing cross section or tapered tip to ~acilitate insertion into the blood vessel. The catheter body 92 is supported at its pro~imal end by a catheter hub 94 which is illustrated : as ha~ing laterally:
proje~ting suture wings:96, 98, although lt is understood that the catheter hub g4 may be provided~with other means (or no means) for the ~retention of the ~; catheter assembl~ 18 on the patient after placement.
: ~ The catheter hub 94 is formed with an integral femal:e luer lock or connector lOO. ~In order to orient the : 25 catheter ~18 in relation to the lnserter unit 12 when the male slip 76 of the needle:ass~em~ly ~4 is inserted into female luer lock 100, ~the proxlmal end of the hub body 21 3 ~L 5 ~ r7 ~;;
W093t25~53 PCT/US93/05~9 ~
!
74 is formed with an orlenting key or lug 102 (see FIG.
1) which is received within an appropriately oriented keyway or orienting notch 104 formed in the proximal end of the luer lock or connector 100.
~s to the se~ection of materials for the manufacture of the several components of the catheteri~ation system 10, it will be understood that the disposable inserter unit 12 must be fabricated, at least as to those walls which will provide visualization of the content of the channels 38, 40, of a transparent material, typically of a moldable thermoplastic material having the requisite properties to withstand sterilization. The needle body 70 is formed of an appropriate metal, typically 304 S.S., such that the port 70d, provided for visualization o~f flashback blood, as will be described, may: be ground into the upper surface o~ the needle body 70. The guide wire 16 may be fabricated o~ metal, plastic, or a combination thereof and is constructed to provide:its spherical or rounded so~t distal tip 16b. Finally, the cathster body 92 incl~udes at leas;t ~some clear or translucent elongated circumferentially e~tending sections and may be fabricated from~ a~ striped single lumen catheter blank which includes circumferentially e~tending sectors of clear polyurethane separated by longitudinally e~tending ; ~ circumferential filler sections of a radiopa~ue polyurethan~. ~Any appropriate technique may be ~;:
~. ~
213~rj lrj! ',1!~','' .' W093/~5~3 P~T/US93/05~9 . ~
, utilized for the manufacture of the catheter body or blank to enable visualization of flashback blood in the first or early visualization flashback chamber, as will now be d~scribed.
~eference will now be made to FIGS. 8A, 88, 9 and 10 for a descriptlon of closed-ended annular first or earl~ visualization flashback chamber, generally designated by the reference numeral 106 formed between the catheter body 92 and the needle body 70 when the catheter assembly 18 is carried on the needle assembly 14 in the over-the-needle position. Specifically, the interior of the catheter body 92 is provided with a relatively shallow longitudinally e~tending well 92d having its distal portion q2e located distally of the first flashback port 70d and its proximal end 92~
located pxogimally of the last of the flashback ports 70d formed in the uppermost surface of the needle bod~
70. Between the distal end 92e of the well ~2d and .
the distal end 92b of the catheter body 92, there is a : 20 relatively snug fit between the interior wall of the catheter body 90 and the exterior wall of the needle body 70. Thus, in the initial ovsr-the-needle position of the catheter ~assembly 18 on the needle assembly 14~ there will be no leakage between the .
distal end 9Ze of the first flashback chamber 106 and the distal end of the needIe assembly 14 when hlood flows from a vessel through the needle bore 70c and ~. ~
~ W0~3/25253 ~ 7 PCT/US93/05~9 i~
; i ~
into the first flashback chamber 106 through ports 70d. Comparably, at the proximal end 92f of the shallow well or recess 92d, thère is a comparable snug fit between the catheter body 92 and the needle body 70 (see the right side o~ FIG. 8A and the left side of FIG. 8B) to close off the pro~imal end of the annular flashback chamber 1~6 to prevent any leakage of blood. Howe~er, air may escape into the atmosphere through the pro~imal end of the annular flashback chamber 106 and between the male slip 76 of the needle assembly 14 and the female luer lock 100 of the catheter assembl~ 18 in order to permit blood flow into the flashback chamber 106.
As seen best in FIG. 8Bi when the wire guide 16 }5 is in the retracted position its spherical distal tip 16b is disposed in a non-obstructing or clearance position 1n relation to the most distal or ~irst blood flashback port 70d encountered by~ the initial blood flow ~rom the needle bore 70c. Various non-obstructing positions can be established fo~ the wjire guide 16 in relation to the first flashback port 70d. In this particular illustrative embodiment, the distal tip 16b ~ of the wlre guide 16 is shown substantially intermediate the distal and pro~imal ends of the ~irst fiashback port 70d whi.ch is adequate ~: to provide an unobstructed blood path to the first flash~ack port 70d, with the spherical tip 16b serving ~ ~ :
WOg3/2s~s3 2 1 3 '1 ~ '1 7 PC~'/US93/05~9 t~
as a diverter of the blood flow. The specific orientation of the distal.tip 16b of the wire guide 16 relative to the needle assembly 14 represents a design compromise. The design objective is to provide a compact and foreshortened system, which requires that the distal tip 16b of the wire guide 16 ~e as close as practical to the distal end 14b of the needle assembly 1~ without interfering with entry of blood into the first flashback chamber 106.
Flashback visualization will occur throughout the length of the first flashback chamber 106 due to the provision of the multiple flashback ports 70d (see FIG. 6). The dlameter of the wire guide 16 is selected in relation to the diamete~ of the needle bore 70c to provide an annular blood flow passage 108 therebetween which communicates with the first flashback chamber 106 through the spaced ports 70d.
, Thus, when the wire guide 16 15 in the retracted - position as shown in FI~ . 8B, t~wo flow paths are established for flashback bloodi namely, a first path through the multiple flashback po;rts 70d and lnto the ~irst flashback chamber 106 and a second path via the annular blood flow passa~ge 108~ e~tending along the longi:tudinal extent of the wire guide 16 from its distal tip 16b, into :the cavity ~2 of the hub body 72, :
through the lateral ports or~;windows ~84, 86, into the cavity S0 formed~at:the~distal end 22b of the body 2~, . , :
, : :
.;:
:' , ,;. ~ .
~ W093l25~53 ~1 3 ~ 5 4 7 PCT/US93/05~9 r''.
''' ' ' ''. ;:
and thence into the distâl ends 38b, 40b of the channels 38, 40 of the second flashback chamber.
During a typical manu~acturing sequence, the disposable inserter unit 12 is initially assembled by connecting the needle assembly 14 to the body 22, with the step 8~ of the needle hub 72 closing off the distal end 22b of the bod~ 22 and with the male needle mounting hub 76 received within the projecting cylindrical wall 48 of the body 22. The guide wire 16 and its actuator 20 is then assembled on the body 22.
The guide wire 16 is threaded through the partition , .
opening 54 aided by the funnel formed at the distal end 42b of the track 42. The guide wire 16 is then advanced through the cavit~- 82 and into the needle bore 70c until the distal tip 16b of the guide wire 16 is spaced proxima1ly o~ the tip 14b of the needle assembly 14 in its flow diverting position in relation to the first of the ports 70d in the needle body 70 (see FIG 8B). t Upon placement of the catheter assembly 18 into its over-the-needle position (see, for e~ampl~e, F~GS.
3, 4), the well 92d formed in the interior of the : . O. ' catheter body 92 cooperates~ wîth the needle body 70 to form the first~ flashback chamber 106. Orientation of the catheter assembly 18 in relation to the needle assembly 14 is accomplished by the key 102 entering the orienting notch 10~; and, in this position, the ,:~
wo 93,25~2 1 ~ 7 PCT/US93/0~9 I
distal catheter tip 92b is disposed proximal to the distal needle tip 70b and in the appropriate position in relation to the sev~ral ports to form the firs~
~lashback chamber 106. Of course, when the guide wire 16 is in ltS retracted position the actuator 20 is at the proximal end 2~a of the body 22 and is held in this position ~or packaging, : sterllization and shipment by the detent mechanism 66 (see FIG. 1 in which the actuator 20 is in a dotted line position slightly forward of the proper retracted position to generally show the detent mechanism 66).
In a typical ~ sequence of use for ; a catheterization procedure, the user prepares the ~:' puncture site in the usual manner and~then peels open the sterilized and sealed package to remove the system :
10. Typically, the s~stem 10 is sold with a protective shield (not shown)~:disposed over the : catheter body 92 and:the projecting distal tip of the needle assembly 19 and this protective shield is removed. By grasping and manipulating the actuating "; i llev.er 20;,j~the user may try out the advancement ,and retracting o~ the spring :;wire gulde 16 through: the needle : assembly 14: to ensure~;~proper feeding.
Additionally, the user may~make the election of whether or~not ~to~ut1lize ~the :suture wings ~96, ~98 since, ~ypically, the suture wings can ~e removed from ~'~ I the c:atheter hub ~94 such that ~the ~user may use a : , ~ W093/2~253 2 1 ~ ~ 5 I 7 PCT/US93/~5849 '~
.: '.
different procedure for securing the catheter assembly 18 to the skin of the patient after placement. After testing and takiny these preliminary steps, the actuating lever 20 is moved to its fully retracted position at the proximal e~d 22a of the body 22 to properly position the distal tip 16b of the guide wire 16 as shown in FIG. 8B.
Thereupon, the user punctures the blood vessel with the needle assembly 14 using a continuous, controlled and slow forward movement, exercising caution to avoid transfixing both vessel walls.
Successful entry into the blood vess~l will be immediately visualized by the appearance of flashback blood initially in the first or early visualization flashback chamber 106 and then in the channels 38, 40 forming the second flashback chamber in the body 22.
The user must take care not to inadvertently puncture both vessel walls incident to the introduction of the needle assembly 14 into the blood vessel since this, in turn, could result in the inadvertent sub-arterial placement of the wire guide 16. ~ .
After stabilizing the position of the needle . . .
assembly 14 and careful advancement of the wire guide ~ 16 via the actuating lever 20 (moving through its relatively short forward stroke), the guide wire 16 will be located within the blood vessel for a length predetermined by the permitted stroke of the actuator ;~
2 1 3 ~ 5 1 r~ ' : - .
lever 20. I~ resistance is encountered while advancing the wire guide 16, the user sh~uld not force such feed and should not retract the wire guide 16 while in the blood vessel since this could inadvertently damage the wire guide 16. Rather, the entire s~stem 10 should be withdrawn from the vessel and a new puncture attempted.
After the w1re guide 16 is positioned, the user firmly grips the body 22 or the needle hub 72 te.g., at the depressions 90) and then advances the catheter assembly 18 ~orwardly along and off the needle assembly 14. The distal end 92b of the catheter assembly 18 tracks the wire guide 16 into the vessel.
If di~fi~ulty is encountered during catheter : 15 advancement, a slight rotation of the catheter hub g4 might be helpful. Thereupon, the user holds the catheter 18 in place and removes the inserter unit 12, at which point the physician attaches the desired stopcoc~, injection cap or connecting tube to the Luer connector 100 of the catheter hub 94.~ The final step isl to secure~ the c~theter to the patient in ja preferred method, for example, by using the wings ~6, 98 and to cover the puncture site with a suitable dressing.
.
~ Z5 From the foregoing, it will be appreciated that :
~': - t~here has been provided an 'exceptionally compact, bloodless design for:placement:of catheters into blood 7 "
W~93/25253 PCT/US93/~5~9 ' , :
vessels which enables the user to readily master a simple insertion technique, thereby increasing the percentage of successful first-time placement.
Flashback blood is effectively contained within the disposable inserter unit 12 and unobstructed blood flow can be stopped prior to separation of the disposable inserter unit 12 from the displaced catheter assembly 18 by appropriately depressing the catheter body 92 to e~fectively close the catheter lumen. On those occasions when it is desirable for the physician to have direct access to the guide wire 16 and its actuator 20, this sub-assembly may be readily removed from its operative and mounted position on the body 22 of the inserter unit 12.
Although the invention has been described with reference to particular embodiments, it is understood that these embodiments are merely illustrative of the different aspects and features of the invention. A
per~on skilled in this art may ma~e numerous modifications to the illustrative embodiments delscribed herein and other arrangeme~ts may be ~devised to implement the essential features of the present '~ invention without departing from the spirit and scope ; of the invention as de-c.ibed and claimed herein.
: ~ .
J
, . ~ .
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects, features and advantages of the present invention will be understood from the following detailed description of a preferred embodiment of the present invention, when taken in conjunction with the accompan~ing drawings wherein:
FIG. 1 is an enlarged, exploded perspective view of a preferred embodiment of the catheterization system of the present invention with the catheter being separated from the inserter unit and with the catheter shown being pinched off to prevent blood flow through the catheter (e.g., after placement ln the blood vessel) and with typical finger positions shown on the inserter unit for one-handed manipulation thereof;
FIG. 2 is a top view of the catheterization system showing the inserter unit and the catheter mounted thereon;
FIG. 3 is a side yiew of the catheterization system shown in FIG. 2 showing the introducer needle in the bevel-up posi~ion and with the guide wire actuatin~
leverl in its~ fully~ retracted position at the proximal end o~ the 1nser~er un1t;
: FI5. 4 is a partial sectional view taken along the lines 4-4 of FIG. 3 and showing details of the internal construction of the lnserter unit including the guide wire and its actuator which are shown in the retracted position :~ .
W093/25253 2 1 3 4 ~ ~1 7 pCT/US93/05~9 ~ ~ ~
FIG. 5 is an enlarged sectional view taken along the lines 5-5 of FIG. 4 and showing the pro~imal end of the inserter unit including the actuator for the wire guide, the detent mechanisms for retaining the wire guide actuator in the retracted position and the flashback chambers;
FIGS. 6A-6D is a series of partial sectional views showing, ~rom top to bottom, the wire guide (FIG.
6~), the body of the inserter unit (FIG. 6B), the introducer needle assembly showing the multiple blood flashback ports in the needle body (FIG. 6C), and the catheter assembly including the catheter body and catheter hub (FIG. 6D);
FIG. 7 is an enlarged section of the area circled in FIG. 4 showi~g details of the permanent connection between the needle hub and the body of the inserter unit and illustrating, by stippling, the blood flow paths from the cavity of the needle hub to the two separate main f1ashhack chambers;
FIG. 8A is an enlarged section of the area circl~d in FIG. 4 (and to the rigllt of the enlargement shown in FIG. 7) showing the releasable conn~ction between the needle hub of the inserter unit and the . .-.-catheter hub;
; 25. FIG. 8B is an enlarged section of the area circled in FI~. 4 (and to the right of t~e enlargement shown in FI~. ~A) showing the details of the W093/25253 21 3 4 5 ~ 7 PCT/US93/05~9 _9_ relationship between the introducer needle, the catheter and the wire guide at the distal ends thereof and illustrating, in particular, the flow of blood by stippling from the bevelled needle tip through the bore o~ the needle and through a needle flashback port into the annular flashback chamber formed between the interior of the catheter and the exterior of the needle;
FIG. 9 is a sectional view:taken along the lines 9-9 of FIG. 8B and showing the relationship between the concentric guide wire, needle and- catheter and showing the shape of the flashback port in the needle and the overall annular shape of the annular flashback chamber;
and FIG. 10 is a sectional view taken along the line 1510- 10 of FIG. 8B at the location where the lumen of the catheter makes physical contact with~the outer diameter of the needle to preclude leakage o~ blood from the distal end of the annular flashbac~ chamber.
:
DESCRIPTION OF THE PREFERRED~EMBODI~ENTS
~, ~20! ~ I ,FIG. 1 shows the catheterization system 10 wit~
its two major components (the ~inserter unit 12 and catheter assembly 18j separated f~ro~m one another for purposes of illustration. The insert~r unit 12 ~which is pre~erably disposable~ after :use) is made up of a neèdl~e a~ssembly 14:, a guide ~wire 16 having an actuator 20 connect~d'to the pro2imal end thereo~ and a body 22.
"' :' W0~3/~5253 2 1 ~ ~ ~ 1 7 ; PCTtUSg3/05~9 1 ....... . .
The needle assembly 14 is connected to the body 22,w~ich body 22 also carries the actuator 20 of the guide wire 16. The actuator 20 is mo~able along the length of the hody 22 ~o advance the guide wire 16 from its normal retracted position to an e~tended position as described in detail hereinbelow. The actuating lever 20 is located such that it may be manipulated by the thumb Fl of the person placing the catheter while the inserter unit 12 is grasped between the forefinger F2 and index finger F3 thereby facilitating one-handed operation of the system lO. Further, there is illustrated a finger F4 placed on the fle~ible portion of the catheter assembly 18 for the purposes of pinching off blood flow (after the catheter assembly 18 has heen inserted into a lS vessel) to enable attachment of an appropriate stop cock or the like.
Prior to use, the catheterization system lO is in the assembled position shown in FIGS~ 2-4, inclusive, in which the inserter unit l2 removably carries the catheter assembly 18 on the needle assembly 14 in an .l ove~r-~he-needle position. FIGS. 2-4 show the actuatojr Z0 in its normal retracted position at the proximal end of the inserter un1t l2. In this retracted position, the distal end of the ~uide wire 16 is located within ?.5 the needle assembly 14: as shown in FIG. 8B. The needle assembly 14 ~5 0~ a length in relation to the catheter assembly 18 such that when the catheter assem~ly 18 is .. W~93/25253 2 1 3 ~ ~ ~1 7 ' PCT/US93/05~9 ..
on the needle assembly 14 the distal end of the needle assembly 1~ (shown to the right in FIGS. 2-4 ~ 8B) extends be~ond the distal end of the catheter assembly 18.
The catheterization system 10 is constructed from four basic parts which are separately shown in FIGS. 6~-6D prior to assembly o~ the s~stem 10. FIG. 6 shows the guide wire 16 and its actuator 20. The proximal end 16a o~ the guide wire 16 is physically attached to the actuator 20 while the distal end 16b is formed with a rounded (e.g., semi-spherical) tip (See FIG. 8B). FIG. 6B shows the body 22 of the inserter unit 12 which body receives the guide wire 16 and sl1dably carries its actuator 2~. Body 22 is connected to the.needle assembly 14, as shown in F.IG. 6C. The needle assembly 14, in turn, carries the over-the-needle catheter assembly 18 shown in FIG. 6D.
The body 22, shown in the enla~rged cross-section ~; of FIG. 5, includes spaced side walls~29, 2~ which, ~or convenience and ease of handling are slightly rounded or , l outwardl~ bowed (see:FIGS. 1 and 5),:,an interconnecting top wall 28 which has a medial and longitudinally e~tending slot 30 and an interconnecting bottom~ wall 32. Additionally, the body 22 is formed with internal dividing w~lls 34, 36 which are appropriately shaped to orm two spaced channels 38, 40; which cons~itute the : :: :
~ second or:main flashback chamber located within the unit . ~ ~
.
W093/25253 2 1 3 4 ~ '~ 7 PCT/US93/05~9 .. ... ..
body 22. Specifically, the walls 24, 34 and the contiguous portions of the ~alls 28, 32 form the elongated channel 38 e~ten~ing along side wall 24 and visible there~hrough, with the channel 40 being S similarly ~vrmed and likewise being visible through its contiguous external wall 26. Centrally of the body 22, divider walls 34, 36 are shaped along with the top and bottom walls 2~, 32: to provide a longitudinally e~tending medial track 42 which, as seen in FIG. 5, is open through top wall 28 of the body 22 through slot 3d which is substantially coe~tensive with the track 42.
Re~erring to FIG. 6B, the body 22 has a progimal end 22a and a distal end 22b. Opening throu~h the pro~imal end 22a of the unit body 22 are the spaced open pro~imal ends of the channels 38, 40 designated respe~tively as 38a, 40a, and the pro~imal open end 42a of the track 42. The proximal ends 38a, 40a of the channels 38, 40 are closed against blood flow by porous : plugs 44, 46 which enable the purging of air. At their ~0 distal ends 38b, 40b, the channels 38, 40 co~municate !~,; with ~he internal cavity 5~, created by the pr~ojecting;
wall ~8. Internal cavity 50 receives the proximal end ~ o~ the needle assembly ~14, as will be subsequeintly 'i : described, to complete paths from t~e distal tip 14b of ~the neadle assembly 14 to the pro~imal ends 38b, 40b of the channels 38, :40.
Dlsposed ~etween the distal ends 38b, 40b of the ~ WO93/252~3 ~ S~1 7 ~(~/US93t05849 )~
, .. ~ . ' ~
channels 38, 40 and closing off the distal end 42b of the track 42 is a transverse partition 52 which is formed with a guide wire receiving opening 54 through which the guide wire 16 is passed for longitudinal movement ~elative to the inserter unit 12. The fit between the guide wire 16, which has uniform diameter, and the opening 54 lS such as not to interfere with easy slidin~ movement thereof but, at the same time, to preclude the flow of blood therethrough and into the track 42 (see FIG. 7). As best shown in FIGS. l and 6~, track 42 is open at its proximal end 42a and along its top as a result of the provision of the longitudinally e~tending and medially disposed slot 30 in the top wall 28 of the body 22. The distal or ~oremost circular ~ace lS 52a of the partition 52 will, as will subsequently be described, divert~the flow of flashback blood into the :: contiguous distal ends 38b, ~Ob of the channels 3~, 40.
~ Referring ne~t to FIGS.~ 1-6 and, in particular~~
to FIG. 5, there is illustxated the construction of the 20: guide wire~actuator 2~0 which is used for moving~ the guide! wire 16 with,in the,track 42 th,rough;a relat:ivelly short stroke (e:.g. the length of the track 42). ~Such : : mo~ement of the~ actuator 2Q results in the projection of :
the sphe~ical:distal tip 16b of the guide~wire 16 beyond :,, 25 ~ the distal t~ip:~ 1~4b :of the needle~ assembly 14 and into :the blood vessel~so~that the guide wire~16 can perform :its ~guiding fun~tion. The: :suide wire actuator 2 ~ ~ -W093/25253 2 1 3 ~ S ~ 7 PCT/US93/05~
includes an upstanding actuating lever 56 which projects above the top wall 28 of the body 22 and is in a position which is readily accessible to the user ~see FIG. 1). The guide wire actuator 20 includes laterally extending stabilizing feet 58, 60 which ride along the flat upper sur~ace 28a of the top wall 28 of the body 22. Projecting downwardly from the stabilizin~ feet 58,60 is a connecting web 62 which, in turn, carries a cylindrical slide member 64 which is attached to the proximal end 16a of the guide wire 16 for advancing and retracting the guide wire 16 as a result of the movement of the actuator 20 between limit positions.
Initially, the actuator 20 is disposed in a ~ully retracted position shown in FIGS. 2 and 3 and contiguous to the pro~imal end 22a of the body 22. The actuator 20 is releasably held in this retracted : position by an app~opriate deten~t mechanism 66 located on the connecting web 62 of the actuator 20 and on the upstanding walls of the slot 30. :The detent mechanism 66 may take a variety o~ forms and here includes , outwardly e~tending ~proj,ections formed on the opposite upstanding walls of the connecting web 62 whi~h are ~: : respectively located between paired positioning projections ~ormed on the upst:anding walls o~ the slot , 30 contiguous to the proximal end 22a of the body 22. .' The projections coact with each other to hold the actuator 20 in the retracted position at tAe pro~imal ; .
, ;.
",~, W093/25253 2 1 ~ ~1 S 'I 7 PCT~US93/05~9 ~ ' ., ~
end 22a o~ the inserter unit 12. In this position, the rounded distal tip 16b of the guide wire 16 is proximal of the distal tip 19b of the needle assembly 14 and optimally in a clearance posi~ion wlth respect to the most distal port 70d (see FIG. 8B), so as not to inhibit the proper functioning of the system, particularly with respect to early visualization of flashback.
Upon movement of the actuator ~20 ~from its initial retracted position toward lts extended position, i~e, toward the distal end 22a of the body 22, t~e leading edge of the upstanding actuating lever 56 and .~ .
~: the leadi~g edges of the stabilizing feet 58, 60 will contact an upstanding abutment 68 located on the body 22 (See FIG. l). Such contact limits the movement of the l5~ ;actuator 20 and the correspond1ng amount of extension of ~ ~
: the distal tip 16b of the gulde,wir:e~16 past the distal ~ ~;
'tlp ~14b of the~ needle assembly 19:and ~i.nto the: blood vessel. The entire~sub-assembly of the actuator 20 and : : :
: the guide wire 16 may be w1thdrawn'~(against the~mlnimal~
'2~ re5istance of the detent mechani:sm 66) from the pro~i:mal' end, 4l2a .of thej gu;ldeway 42 so that the guiqe wi~re~,16 and 'actuator 20 ;may be;separated from the sys~tem~lO for~ use indépendently o~ ~the system. ::.: ~
Refer:ence wi~1:1;now be made~to FIG.:~6 in 2~5~ conjunction~with;FIGS. 4~and~7~for~an explanation~of the~
need1~ assembly~;~14:~and~the~manner~in~;wh~ich it is connect~d to the:;~body:~22~
W093/25~53 2 1 ~ 7 pCT/US93/05~9 The needle assembly 14 includes an elongated needle body 70 o~ an appropriate gauge t~pically in the range of 16-24. The needle body 70 is mounted at its pro~imal end 70a on the needle hub 72 and is ~ormed with a bevelled distal tip 70b. The needle body 70 includes a needle bore 70c of uniform cross~section which receives, with appropriate clearance and as will subse~uently be described, the wire guide 16. The operative orientation of the needle body 70 is with the bevel 70b up. Also along the uppermost surface of th;e needle bod~ 70, there are provided a series of flashback blood ports 70d arranged in spaced relation with each other along a length of the needle body 70. The blood ports 70d, along with the catheter assembly 18, provide ; 15 a first flashback chamber. Specifically, the ports 70d in: the needle body 70 are spaced proximally of the bevelled tip 70b to provide an lntermediate section of the needle body 70 which will cooperate with the catheter 18 to provide an early or first flashback '20 chamber, located ~etween the outside wall of the needle bod~ j70 and inside wall of the catheter ~assembly 18l.
The spacing of the most distal port 70d is such that only a relatiYely short path for blood flow exists from . ~-the bevelled distal tip 70b of the needle body 70 2S through the needle bore 70c and into such ~irst of the ~: series of flashback ports 70d.
The needle hub 72:includes a hub body 74 having '': ~................................ ' ~ W093/~5253 213 4 S ~ 7 Pcr/uss3/o~s4~
a pro~imal end 74a and a distal end 74b. At its distal end 74b, the needle body 74 is formed with a male luer slip or cylindrical supporting plug 76 which is sized for releasable but fluid tight (but not air tight) S connection to a female luer lock connector or hub, to be described, on the pr~o~imal end of the catheter assembly 18. Contiguous to its proximal end 74a, the hub body 74 is formed with a male needle mounting hub 78 which is sized to be received within the projecting cylindrical wall 48 of the body 22. The hub body 74 includes a step~80 which is s1zed to: fit into and close : o~~ the cavity 50 in the distal end 22b o~ the body 22, as seen best in FIGS. 4 and 7.
~eferring now to FIGS. 5B, 6C and 7, the hub lS body 74 is provided with an internal cavity 82 which, at : ' :
:~ its distal end, communicates with the needle bore 70c and, at its progimal end, is formed with ports 84, 86.
: whi:ch establish lateral openings at either side of the ; partition 52 of the body 22 such that the flashback : 20 blood diverted by the~surface 52a may flow into ~the ad~acent distal ends 38b, 40b~of the channels 38, 40 (See FIG. 7). In-between the step 80 a~d the ma:le luer sll~p 76:, the needle hub body ~74 lS formed w1th four~
: radially e~tending finger p1eces~88 at 90~
circumferential ' spacings which~ are~ appropriately -.
contour:ed a't:t;heir outermost edges to provide gripping : :
or::finger r~eceiving notches or~ depressions 90 (see, in W093/25253 2 1 3 d~ 5 ~1 ~ PCI /VSg3/05849 r~
particular, FIG. 1). When the hub 72 of the needle assembly 14 is mounted on the di.stal end of the body 22 and permanently attached thereto for e~ample by use of an appropriate adhesive or by sonic welding or the like, it will be seen that a con~inuous path for flashback blood is established from the bevelled tip 70b of the needle body 70 through needle hub cavity 82 and via the ports or windows 84, 86 into the channels 38, 40 formed in the body 22.
As best shown in FIG. 6, the catheter assembly 18 is seen to include a~ elongated catheter body 92 havi~g pro~imal and distal ends 92a, g2b ~nd an internal lumen or bore 92c. The end of the catheter body 92 contiguous to the distal tip 92b is formed with a progressively decreasing cross section or tapered tip to ~acilitate insertion into the blood vessel. The catheter body 92 is supported at its pro~imal end by a catheter hub 94 which is illustrated : as ha~ing laterally:
proje~ting suture wings:96, 98, although lt is understood that the catheter hub g4 may be provided~with other means (or no means) for the ~retention of the ~; catheter assembl~ 18 on the patient after placement.
: ~ The catheter hub 94 is formed with an integral femal:e luer lock or connector lOO. ~In order to orient the : 25 catheter ~18 in relation to the lnserter unit 12 when the male slip 76 of the needle:ass~em~ly ~4 is inserted into female luer lock 100, ~the proxlmal end of the hub body 21 3 ~L 5 ~ r7 ~;;
W093t25~53 PCT/US93/05~9 ~
!
74 is formed with an orlenting key or lug 102 (see FIG.
1) which is received within an appropriately oriented keyway or orienting notch 104 formed in the proximal end of the luer lock or connector 100.
~s to the se~ection of materials for the manufacture of the several components of the catheteri~ation system 10, it will be understood that the disposable inserter unit 12 must be fabricated, at least as to those walls which will provide visualization of the content of the channels 38, 40, of a transparent material, typically of a moldable thermoplastic material having the requisite properties to withstand sterilization. The needle body 70 is formed of an appropriate metal, typically 304 S.S., such that the port 70d, provided for visualization o~f flashback blood, as will be described, may: be ground into the upper surface o~ the needle body 70. The guide wire 16 may be fabricated o~ metal, plastic, or a combination thereof and is constructed to provide:its spherical or rounded so~t distal tip 16b. Finally, the cathster body 92 incl~udes at leas;t ~some clear or translucent elongated circumferentially e~tending sections and may be fabricated from~ a~ striped single lumen catheter blank which includes circumferentially e~tending sectors of clear polyurethane separated by longitudinally e~tending ; ~ circumferential filler sections of a radiopa~ue polyurethan~. ~Any appropriate technique may be ~;:
~. ~
213~rj lrj! ',1!~','' .' W093/~5~3 P~T/US93/05~9 . ~
, utilized for the manufacture of the catheter body or blank to enable visualization of flashback blood in the first or early visualization flashback chamber, as will now be d~scribed.
~eference will now be made to FIGS. 8A, 88, 9 and 10 for a descriptlon of closed-ended annular first or earl~ visualization flashback chamber, generally designated by the reference numeral 106 formed between the catheter body 92 and the needle body 70 when the catheter assembly 18 is carried on the needle assembly 14 in the over-the-needle position. Specifically, the interior of the catheter body 92 is provided with a relatively shallow longitudinally e~tending well 92d having its distal portion q2e located distally of the first flashback port 70d and its proximal end 92~
located pxogimally of the last of the flashback ports 70d formed in the uppermost surface of the needle bod~
70. Between the distal end 92e of the well ~2d and .
the distal end 92b of the catheter body 92, there is a : 20 relatively snug fit between the interior wall of the catheter body 90 and the exterior wall of the needle body 70. Thus, in the initial ovsr-the-needle position of the catheter ~assembly 18 on the needle assembly 14~ there will be no leakage between the .
distal end 9Ze of the first flashback chamber 106 and the distal end of the needIe assembly 14 when hlood flows from a vessel through the needle bore 70c and ~. ~
~ W0~3/25253 ~ 7 PCT/US93/05~9 i~
; i ~
into the first flashback chamber 106 through ports 70d. Comparably, at the proximal end 92f of the shallow well or recess 92d, thère is a comparable snug fit between the catheter body 92 and the needle body 70 (see the right side o~ FIG. 8A and the left side of FIG. 8B) to close off the pro~imal end of the annular flashback chamber 1~6 to prevent any leakage of blood. Howe~er, air may escape into the atmosphere through the pro~imal end of the annular flashback chamber 106 and between the male slip 76 of the needle assembly 14 and the female luer lock 100 of the catheter assembl~ 18 in order to permit blood flow into the flashback chamber 106.
As seen best in FIG. 8Bi when the wire guide 16 }5 is in the retracted position its spherical distal tip 16b is disposed in a non-obstructing or clearance position 1n relation to the most distal or ~irst blood flashback port 70d encountered by~ the initial blood flow ~rom the needle bore 70c. Various non-obstructing positions can be established fo~ the wjire guide 16 in relation to the first flashback port 70d. In this particular illustrative embodiment, the distal tip 16b ~ of the wlre guide 16 is shown substantially intermediate the distal and pro~imal ends of the ~irst fiashback port 70d whi.ch is adequate ~: to provide an unobstructed blood path to the first flash~ack port 70d, with the spherical tip 16b serving ~ ~ :
WOg3/2s~s3 2 1 3 '1 ~ '1 7 PC~'/US93/05~9 t~
as a diverter of the blood flow. The specific orientation of the distal.tip 16b of the wire guide 16 relative to the needle assembly 14 represents a design compromise. The design objective is to provide a compact and foreshortened system, which requires that the distal tip 16b of the wire guide 16 ~e as close as practical to the distal end 14b of the needle assembly 1~ without interfering with entry of blood into the first flashback chamber 106.
Flashback visualization will occur throughout the length of the first flashback chamber 106 due to the provision of the multiple flashback ports 70d (see FIG. 6). The dlameter of the wire guide 16 is selected in relation to the diamete~ of the needle bore 70c to provide an annular blood flow passage 108 therebetween which communicates with the first flashback chamber 106 through the spaced ports 70d.
, Thus, when the wire guide 16 15 in the retracted - position as shown in FI~ . 8B, t~wo flow paths are established for flashback bloodi namely, a first path through the multiple flashback po;rts 70d and lnto the ~irst flashback chamber 106 and a second path via the annular blood flow passa~ge 108~ e~tending along the longi:tudinal extent of the wire guide 16 from its distal tip 16b, into :the cavity ~2 of the hub body 72, :
through the lateral ports or~;windows ~84, 86, into the cavity S0 formed~at:the~distal end 22b of the body 2~, . , :
, : :
.;:
:' , ,;. ~ .
~ W093l25~53 ~1 3 ~ 5 4 7 PCT/US93/05~9 r''.
''' ' ' ''. ;:
and thence into the distâl ends 38b, 40b of the channels 38, 40 of the second flashback chamber.
During a typical manu~acturing sequence, the disposable inserter unit 12 is initially assembled by connecting the needle assembly 14 to the body 22, with the step 8~ of the needle hub 72 closing off the distal end 22b of the bod~ 22 and with the male needle mounting hub 76 received within the projecting cylindrical wall 48 of the body 22. The guide wire 16 and its actuator 20 is then assembled on the body 22.
The guide wire 16 is threaded through the partition , .
opening 54 aided by the funnel formed at the distal end 42b of the track 42. The guide wire 16 is then advanced through the cavit~- 82 and into the needle bore 70c until the distal tip 16b of the guide wire 16 is spaced proxima1ly o~ the tip 14b of the needle assembly 14 in its flow diverting position in relation to the first of the ports 70d in the needle body 70 (see FIG 8B). t Upon placement of the catheter assembly 18 into its over-the-needle position (see, for e~ampl~e, F~GS.
3, 4), the well 92d formed in the interior of the : . O. ' catheter body 92 cooperates~ wîth the needle body 70 to form the first~ flashback chamber 106. Orientation of the catheter assembly 18 in relation to the needle assembly 14 is accomplished by the key 102 entering the orienting notch 10~; and, in this position, the ,:~
wo 93,25~2 1 ~ 7 PCT/US93/0~9 I
distal catheter tip 92b is disposed proximal to the distal needle tip 70b and in the appropriate position in relation to the sev~ral ports to form the firs~
~lashback chamber 106. Of course, when the guide wire 16 is in ltS retracted position the actuator 20 is at the proximal end 2~a of the body 22 and is held in this position ~or packaging, : sterllization and shipment by the detent mechanism 66 (see FIG. 1 in which the actuator 20 is in a dotted line position slightly forward of the proper retracted position to generally show the detent mechanism 66).
In a typical ~ sequence of use for ; a catheterization procedure, the user prepares the ~:' puncture site in the usual manner and~then peels open the sterilized and sealed package to remove the system :
10. Typically, the s~stem 10 is sold with a protective shield (not shown)~:disposed over the : catheter body 92 and:the projecting distal tip of the needle assembly 19 and this protective shield is removed. By grasping and manipulating the actuating "; i llev.er 20;,j~the user may try out the advancement ,and retracting o~ the spring :;wire gulde 16 through: the needle : assembly 14: to ensure~;~proper feeding.
Additionally, the user may~make the election of whether or~not ~to~ut1lize ~the :suture wings ~96, ~98 since, ~ypically, the suture wings can ~e removed from ~'~ I the c:atheter hub ~94 such that ~the ~user may use a : , ~ W093/2~253 2 1 ~ ~ 5 I 7 PCT/US93/~5849 '~
.: '.
different procedure for securing the catheter assembly 18 to the skin of the patient after placement. After testing and takiny these preliminary steps, the actuating lever 20 is moved to its fully retracted position at the proximal e~d 22a of the body 22 to properly position the distal tip 16b of the guide wire 16 as shown in FIG. 8B.
Thereupon, the user punctures the blood vessel with the needle assembly 14 using a continuous, controlled and slow forward movement, exercising caution to avoid transfixing both vessel walls.
Successful entry into the blood vess~l will be immediately visualized by the appearance of flashback blood initially in the first or early visualization flashback chamber 106 and then in the channels 38, 40 forming the second flashback chamber in the body 22.
The user must take care not to inadvertently puncture both vessel walls incident to the introduction of the needle assembly 14 into the blood vessel since this, in turn, could result in the inadvertent sub-arterial placement of the wire guide 16. ~ .
After stabilizing the position of the needle . . .
assembly 14 and careful advancement of the wire guide ~ 16 via the actuating lever 20 (moving through its relatively short forward stroke), the guide wire 16 will be located within the blood vessel for a length predetermined by the permitted stroke of the actuator ;~
2 1 3 ~ 5 1 r~ ' : - .
lever 20. I~ resistance is encountered while advancing the wire guide 16, the user sh~uld not force such feed and should not retract the wire guide 16 while in the blood vessel since this could inadvertently damage the wire guide 16. Rather, the entire s~stem 10 should be withdrawn from the vessel and a new puncture attempted.
After the w1re guide 16 is positioned, the user firmly grips the body 22 or the needle hub 72 te.g., at the depressions 90) and then advances the catheter assembly 18 ~orwardly along and off the needle assembly 14. The distal end 92b of the catheter assembly 18 tracks the wire guide 16 into the vessel.
If di~fi~ulty is encountered during catheter : 15 advancement, a slight rotation of the catheter hub g4 might be helpful. Thereupon, the user holds the catheter 18 in place and removes the inserter unit 12, at which point the physician attaches the desired stopcoc~, injection cap or connecting tube to the Luer connector 100 of the catheter hub 94.~ The final step isl to secure~ the c~theter to the patient in ja preferred method, for example, by using the wings ~6, 98 and to cover the puncture site with a suitable dressing.
.
~ Z5 From the foregoing, it will be appreciated that :
~': - t~here has been provided an 'exceptionally compact, bloodless design for:placement:of catheters into blood 7 "
W~93/25253 PCT/US93/~5~9 ' , :
vessels which enables the user to readily master a simple insertion technique, thereby increasing the percentage of successful first-time placement.
Flashback blood is effectively contained within the disposable inserter unit 12 and unobstructed blood flow can be stopped prior to separation of the disposable inserter unit 12 from the displaced catheter assembly 18 by appropriately depressing the catheter body 92 to e~fectively close the catheter lumen. On those occasions when it is desirable for the physician to have direct access to the guide wire 16 and its actuator 20, this sub-assembly may be readily removed from its operative and mounted position on the body 22 of the inserter unit 12.
Although the invention has been described with reference to particular embodiments, it is understood that these embodiments are merely illustrative of the different aspects and features of the invention. A
per~on skilled in this art may ma~e numerous modifications to the illustrative embodiments delscribed herein and other arrangeme~ts may be ~devised to implement the essential features of the present '~ invention without departing from the spirit and scope ; of the invention as de-c.ibed and claimed herein.
: ~ .
J
, . ~ .
Claims (15)
1. A system for introducing an over-the-needle catheter into a blood vessel comprising a body, a hollow needle body having a proximal end connected to said body and formed with a distal needle tip and at least one port close to said needle tip, a catheter body having a lumen terminating at a distal catheter tip, said catheter body adapted to be carried on said needle body and being dimensioned in relation to said needle body such that upon placement of said catheter body over said needle body said catheter body and said needle body cooperate to form a first flashback chamber therebetween, said first chamber being in communication with the interior of said needle body through said port, and said catheter body being at least partially translucent to enable the visualization of blood flow into said first chamber upon insertion of said needle tip into a blood vessel, a guide wire having a distal end, said guide wire slidably mounted in said body and within said needle body and dimensioned in relation to said needle body to provide a blood flow passage therebetween, said guide wire being movable between a first position in which its distal end is wholly within said needle body and a second position in which said distal end extends beyond said needle tip, a second flashback chamber formed by and located in said body and connected to said needle body to receive blood flow upon insertion of said needle tip into a blood vessel.
2. A system according to claim 1 wherein when said guide wire is in said first position, said distal end is in a clearance position with respect to said port.
3. A system according to claim 1 wherein said second chamber includes venting means to allow air to escape from said second chamber but not blood.
4. A system according to claim 1 wherein said body includes mounting means for slidably receiving said guide wire, said mounting means including a partition having a guide wire opening, said guide wire being disposed through said guide wire opening with a sliding fit which precludes blood flow therethrough.
5. A system according to claim 4 wherein said partition extends in a direction substantially transverse to the path of movement of said guide wire.
6. A system according to claim 5 wherein said partition is arranged to divert the flow of flashback blood from said needle body to said second chamber.
7. A system according to claim 4 wherein said body includes a track formed therein and terminating at one end in said partition, said guide wire having a proximal end extending into said track and connected to an actuator slidably mounted in said track.
8. A system according to Claim 7 in which said actuator includes a lever which extends external to said body for moving said guide wire.
9. A system for introducing an over-the-needle catheter into a blood vessel comprising an inserter unit including a body having a blood flashback chamber, a hollow needle body connected to said body and including a distal needle tip, a catheter body removably carried on said needle body and formed with a lumen terminating at a distal tip, a guide wire having a distal tip, means on said body for mounting said guide wire thereon for movement between a retracted position in which said guide wire distal tip is within said needle body and an extended position in which said guide wire distal tip extends beyond said needle tip to serve as a guide for said catheter body during introduction of said catheter body into a blood vessel, said guide wire being dimensioned in relation to the interior of said needle body to define an annular flashback passage leading from said needle tip through said needle body to said flashback chamber.
10. A system according to claim 9 wherein said means on said body for mounting said guide wire includes a track formed in said body and an actuator slidably mounted in said track and operatively connected to said guide wire.
11. A system according to claim 10 wherein said track has proximal and distal track ends and said body includes a partition closing said distal end of said track, said partition being formed with a partition opening through which said guide wire extends, said partition opening being dimensioned to provide a sliding fit with said guide wire whereby said track is effectively blocked from receiving flashback blood flowing into said flashback chamber.
12. A system according to claim 11 wherein said proximal track end is opened such that said actuator and guide wire may be removed from said body.
13. A system according to claim 12 including detent means on said body and said actuator for releasably retaining said actuator against movement in said track and retaining said guide wire in said retracted position.
14. A system for introducing an over-the-needle catheter into a blood vessel comprising a needle assembly including a needle body defining a needle bore and terminating at a distal needle tip, said needle body being provided with at least one flashback port contiguous to said needle tip, a catheter assembly including a catheter body having a lumen terminating at a distal catheter tip, said catheter body being dimensioned in relation to said needle body such that upon placement of said catheter in an over-the-needle position on said needle, said catheter and said needle cooperate to provide a first flashback chamber which chamber is in communication with said needle bore through said flashback port, said catheter body being at least partially translucent to enable the visualization of blood flow into said first flashback chamber upon insertion of said needle tip into a blood vessel to initiate blood flow into said needle body, a guide wire having a distal end and mounted in said needle bore and dimensioned in relation to said needle body to provide a blood flow passage therebetween, said guide wire having a retracted position in which its distal end is substantially clear of said flashback port and contiguous to said needle tip and an extended position in which said guide wire distal end extends beyond said needle tip, said needle assembly connected to a body and said guide wire slidably mounted in said body, an actuator mounted in said body for movement and operatively connected to said guide wire for moving said guide wire between its retracted position and its extended position, a second flashback chamber located in said body, pathway means in said body for establishing a blood flow path from said needle bore to said second flashback chamber, said body being separable from said catheter assembly after said catheter assembly is placed in a blood vessel.
15. A system according to Claim 14 wherein said second flashback chamber includes venting means to vent air from said second flashback chamber to the atmosphere and retain flashback blood in said second flashback chamber.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/899,785 | 1992-06-17 | ||
| US07/899,785 US5246426A (en) | 1992-06-17 | 1992-06-17 | Catheterization system |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2134547A1 CA2134547A1 (en) | 1993-12-23 |
| CA2134547C true CA2134547C (en) | 1998-07-14 |
Family
ID=25411562
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002134547A Expired - Lifetime CA2134547C (en) | 1992-06-17 | 1993-06-17 | Catheterization system |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US5246426A (en) |
| EP (1) | EP0646025B1 (en) |
| JP (1) | JPH07507945A (en) |
| AT (1) | ATE164770T1 (en) |
| AU (1) | AU663455B2 (en) |
| CA (1) | CA2134547C (en) |
| DE (1) | DE69317889T2 (en) |
| DK (1) | DK0646025T3 (en) |
| ES (1) | ES2117712T3 (en) |
| WO (1) | WO1993025253A1 (en) |
| ZA (1) | ZA934323B (en) |
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-
1992
- 1992-06-17 US US07/899,785 patent/US5246426A/en not_active Expired - Lifetime
-
1993
- 1993-06-17 ZA ZA934323A patent/ZA934323B/en unknown
- 1993-06-17 EP EP93916613A patent/EP0646025B1/en not_active Expired - Lifetime
- 1993-06-17 ES ES93916613T patent/ES2117712T3/en not_active Expired - Lifetime
- 1993-06-17 DE DE69317889T patent/DE69317889T2/en not_active Expired - Lifetime
- 1993-06-17 AT AT93916613T patent/ATE164770T1/en not_active IP Right Cessation
- 1993-06-17 CA CA002134547A patent/CA2134547C/en not_active Expired - Lifetime
- 1993-06-17 WO PCT/US1993/005849 patent/WO1993025253A1/en active IP Right Grant
- 1993-06-17 DK DK93916613T patent/DK0646025T3/en active
- 1993-06-17 JP JP6501825A patent/JPH07507945A/en active Pending
- 1993-06-17 AU AU46407/93A patent/AU663455B2/en not_active Ceased
Also Published As
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|---|---|
| EP0646025A4 (en) | 1995-05-24 |
| US5246426A (en) | 1993-09-21 |
| EP0646025A1 (en) | 1995-04-05 |
| ZA934323B (en) | 1996-02-16 |
| DE69317889D1 (en) | 1998-05-14 |
| AU4640793A (en) | 1994-01-04 |
| DE69317889T2 (en) | 1998-09-03 |
| ATE164770T1 (en) | 1998-04-15 |
| ES2117712T3 (en) | 1998-08-16 |
| CA2134547A1 (en) | 1993-12-23 |
| EP0646025B1 (en) | 1998-04-08 |
| DK0646025T3 (en) | 1999-01-18 |
| WO1993025253A1 (en) | 1993-12-23 |
| AU663455B2 (en) | 1995-10-05 |
| JPH07507945A (en) | 1995-09-07 |
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| EEER | Examination request | ||
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