CA2024285C - Intravascular placement apparatus - Google Patents
Intravascular placement apparatusInfo
- Publication number
- CA2024285C CA2024285C CA002024285A CA2024285A CA2024285C CA 2024285 C CA2024285 C CA 2024285C CA 002024285 A CA002024285 A CA 002024285A CA 2024285 A CA2024285 A CA 2024285A CA 2024285 C CA2024285 C CA 2024285C
- Authority
- CA
- Canada
- Prior art keywords
- septum
- hardness
- needle
- cannula
- channel
- 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 - Fee Related
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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M39/0606—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof without means for adjusting the seal opening or pressure
Abstract
The invention provides an intravascular placement apparatus adapted for operative association with an introducer needle. The apparatus provides a cannula provided with a connector hub at its remote end, a self-sealing septum disposed across the internal lumen of the cannula whereby the cannula can be posi-tioned by co-operation with the introducer needle, and a blunt hollow adapter adapted to penetrate a channel in the septum. The invention lies in providing a self-sealing septum of a resilient material which ages rapidly after forming to a point where resilience is not significantly further effected by time. Preferably the channel is formed in situ in the septum when the septum has aged for a predetermined period.
Description
202~28~
The present invention relates to an intravascular placement appuratus, and particularly to such an apparatus adapted to prevent the leakage of body fluids and to nlleviute the problem of particles dislodged from a self-sealing septum 6 blocking or interfering with the flow of a drug during allmini~tration.
The intravascular placement of a plastics cannula by means of an introducer needle is a comrnon medical procedure in order to :l~lmini~ter fluids or drugs into the vascular system, or to sample or monitor blood therefrom. A typical method of utilising such an apparatus is to penetrate the skin and the subcutaneous tissue and thus enter, for example, a vein with a needle carrying a plastics cannula so that both can pass into the vein or the blood vessel. When the needle is withdrawn the plastics cannula is left in the vein and a hub disposed on the cannula at it~ remote end may then be coupled to an admini~tration set or other suitable apparatus. However, during withdrawal of the needle from cannula blood escapes until the cannula is connected to said ad~ini~t~ation set or other apparatus.
Blood spillage during needle withdrawal can often be controlled by digital pressure on the skin adjacent the puncture to compress the vein ahead of the cannula tip. Peripheral veins have internal valves therein to prevent backflow of blood, and therefore pressure on the vein ahead of the cannula in the direction of flow of venus blood tends to control blood spillage fiom the cannula. This technique is effective but occupies both hands of the operator, iB not possible with all vein~, and requiles a high level of competence.
This problem has been addressed in our W088/00842 which provides an intravascular placement apparatus adapted for operative association with an 20242~
introducer needle; said apparatus comprising, a cannula provided with a connecter hub at its remote end, and a self-sealing septum disposed across the internal lumen of the cunnula whereby the cannula can be positioned with the introducer needle. The use of a self-sealing septum prevents the back flow of blood or other fluids and allows the cannula to be positioned by less skilled staff.
The material fiom which the septum is formed is usually an elastomeric self-sealing rubber or plastics material. It has been known that a disadvantage of conventional needle tip designs, when utilised for co-operation with such an elastomeric septum is the prol)lem of "coring". Coring OCCUI'S when the self-sealing septum material gets held in the needle lumen und either blocks the lumen or becomes discharged into the vascular system of the patient. This problem has been addressed in W089/06653 (Baxter International Inc). The Baxter disclosure provides a blunt hollow adaptor at the distal end of an extension piece of a vascular placement apparatus so that the hollow adaptor will penetrute a prefolmed channel in the self-sealing septum and thereby form a channel fiom the extension piece to the cannula. The blunt hollow adaptor may be coupled directly to an administration set or via an extension piece, so that any change over in the administlation set, for example to change one fluid for another, does not entail detnchment of the adaptor from the cannula.
The rigid hollow adaptor is prefelably formed of a metal Ol a rigid plastics material. An advantage of this last type of arrangement is that the sub6tantially rigid blunt adaptol prevents needle-stick, 20242~
The arrangen1ent of Baxter includes in a first aspect a thin pre-slit septum which may be penetrated by a blunt hollow adaptol. This arrangement is prone to problems in that after use over a number of engagement and dis-engagement cycle~, the pre-slit disc shaped septum does not nece~fllily close 6 entirely and this allows of the possibility of infection. In the second aspect of the Baxter disclosure there is provided a relutively large blunt hollow adaptor adapted to enter a pre-slit or partially pre-slit septum. The relatively large bore of the blunt adaptor neces~arily causes an amount of collateral damage to the septum particularly when the resilient material of the septum has lost some of its resilience through a~ing.
We have now found that "coring" cun be prevented, or at least reduced to a negligible problem, by providing an entile r esilient septum, preferably associated with an introducer needle which both penetrates the septum, passes down the cflnnllla and acts to assist the introduction of the cannula at the injection site.
Correctly used, the introducer needle will position the channel in the septum at a position, for ex~mple co-axial, where the blunt adaptor will be aligned with axis of the cannula. The pre-forming of the channel in the septum tends to result in mis-tllignr~ent of the channel with the blunt needle.
The performance of this arrangement is signific~ntly improved if the resilient septum is of a bio-compatihle plastic or rubbel material with aging characteristics. As is well known some plastics materials and rubbels, for example natural rubbels, change theil charactelistics with age.
The invention therefore comprehends a resiliellt septum of a natural Ol synthetic resilient material which when initially positioned in in itæ fresh state in the body of the vascular placement apparatus is fully resilient, thereby forming a good seal with the body components. After a given peliod 6 of time, the resilient material nges such that relative hardness thereof is increased.
This allows the blunt hollow adaptor to penetrate the channel formed in septum by the introducer needle without displacing particles into the lumen of the same. The materials f`or the septum may be any synthetic or natural plastics or rubber material~ which include an aging chalacteristic. The aging characteristic is the increase in hardness over a short aging period followed bya long period when the hardness does not signiflcantly change as may be gr~phiçfllly characterised by a 6igmate cul~e. An example of this material is bio conlpfltil~le rubber but other synthetic plastic materials are available with these charactelistics which are readily available to those skilled in the art bysimple practical experimentatiun.
Accordingly the present invention is charactelised in that the self-sealing BeptUm iB formed of a resilient material which ages rapidly after forming to a point where resilience is not significantly further effected by time~ and in that ~0 a channel is formed in the septum when the septum has aged for the said pre-determined period of time.
Preferably the resilient material is a biocompatible natural rubber and the pre-determined period of time is 2-5 weeks, most preferably about 3 weeks. It will be appreciated that the pre-cletelmined pelio~l depends upon the plecise 2a24~
constituentæ of the chosen material. We have found by use of this technique a that blunt hollow adaptor can be introduced into the septum without fi~flnt coling.
In a preferred form the invention the channel is formed l~y an introducel needle us hereinbefore described, in which case the hub a~emhly is most preferably provided with a convergent inner-plofile to guide the intloducel needle point to a position at which it is coaxial with the lumen of the cannula in use.
The hub may be adupted for connection with an extension piece carlyillg said blunt hollow adaptor; the opelative end of the blunt hollow adaptor iB
preferably chSlmpheled to produce a low fiiction surface. The low fiiction eulface muy be achieved by electlonic smoothing Ol by the provi~ion of a low friction coflting, for example "Teflon" (Registered Trade Malk).
One embodiment of the invention will llOW be de~cribed, by way of illustr~tion only, with reference to the accompanying drawillg which shows in plan, and in part cross-æection, in arlangement in accordance to the present invention.
With reference to the drawing a plastics cannula (1) is formed with a hub aæsembly (4) which in this palticulal inætance forms palt of a Luel-lock of known type. The cannula (1) haæ a lumen such that it may be penetrated by an intloducer needle (2) to an extent that the introducel needle (2) extends from the end of the cannul~ (1) in use.
The introducer needle (2) with the cannula (1) disposed thereabout may then be introduced into a blood vessel of a patient. The needle (2) may then be withdrawn leaving the cannula (1) in place.
In accordance with the present invention, a self-sealing septum (3) formed of a bio-compatible natural rubber, is provided within the hub (4) on manufacture. This septum (3) is freshly manufactured before being positioned and is entire (i.e., has no channel therein).
An extension piece shown generally at (6) comprises a blunt hollow adaptor (5) which is interconnected with a Luer-taper (7). The Luer-taper (7) is provided with a Luer lock* element (8) for inter-engagement with a Luer-lock arrangement on the periphery of the hub (4) in conventional fashion. The extension piece (6) is adapted to inter-connect the Luer-lock with a connector (9) remote therefrom for ready inter-connection of an administration set (10) or any other medical apparatus.
In use, the introducer needle (2) is urged through the septum (3) so that it passes along the cannula (1). It will be observed that interior faces of the hub (4) are tapered at (4A) to provide a relatively small "target area" and are still matched to the Luer-taper (7). The withdrawal of the needle (2) when the cannula (1) is located within the blood vessel then leaves the channel in the septum (3) which is sealed by the aged resilient material.
The blunt hollow adaptor (5) may then be introduced into the hub (4) and guided towards the central portion of the septum thereby. The blunt hollow adaptor contacts the septum (3) and an end portion thereof presses on the * a registered trade-mark of Becton, Dickinson and Company 2Q242~
same and enters the channel. The end of adaptor (3) is thus guided into the chflnnel formed by the introducel needle (2) to the extent that continued movement of the Luer-taper (7) towards the septum (3) causes the blunt hollow adaptor (6) to penetrate the septum (3) completely and thereby e~t~hli~h a ~elf-sealed fluid path between the cannula (1) and adapto~ (9)~ The Luer-lock element (8) may then be inter-engaged in the usual way with hub (4) thereby locking the two together.
An advantage of the intravascular placement apparatus in accordance to the present invention is that not only do neither the cannula (1) or the adapto (5) require a sharp point and accordingly the danger of needle stick by this appal'atu6 iB largely speaking obviated, but also the problem of coring is at least s~lhstflnti~lly prevented.
The present invention relates to an intravascular placement appuratus, and particularly to such an apparatus adapted to prevent the leakage of body fluids and to nlleviute the problem of particles dislodged from a self-sealing septum 6 blocking or interfering with the flow of a drug during allmini~tration.
The intravascular placement of a plastics cannula by means of an introducer needle is a comrnon medical procedure in order to :l~lmini~ter fluids or drugs into the vascular system, or to sample or monitor blood therefrom. A typical method of utilising such an apparatus is to penetrate the skin and the subcutaneous tissue and thus enter, for example, a vein with a needle carrying a plastics cannula so that both can pass into the vein or the blood vessel. When the needle is withdrawn the plastics cannula is left in the vein and a hub disposed on the cannula at it~ remote end may then be coupled to an admini~tration set or other suitable apparatus. However, during withdrawal of the needle from cannula blood escapes until the cannula is connected to said ad~ini~t~ation set or other apparatus.
Blood spillage during needle withdrawal can often be controlled by digital pressure on the skin adjacent the puncture to compress the vein ahead of the cannula tip. Peripheral veins have internal valves therein to prevent backflow of blood, and therefore pressure on the vein ahead of the cannula in the direction of flow of venus blood tends to control blood spillage fiom the cannula. This technique is effective but occupies both hands of the operator, iB not possible with all vein~, and requiles a high level of competence.
This problem has been addressed in our W088/00842 which provides an intravascular placement apparatus adapted for operative association with an 20242~
introducer needle; said apparatus comprising, a cannula provided with a connecter hub at its remote end, and a self-sealing septum disposed across the internal lumen of the cunnula whereby the cannula can be positioned with the introducer needle. The use of a self-sealing septum prevents the back flow of blood or other fluids and allows the cannula to be positioned by less skilled staff.
The material fiom which the septum is formed is usually an elastomeric self-sealing rubber or plastics material. It has been known that a disadvantage of conventional needle tip designs, when utilised for co-operation with such an elastomeric septum is the prol)lem of "coring". Coring OCCUI'S when the self-sealing septum material gets held in the needle lumen und either blocks the lumen or becomes discharged into the vascular system of the patient. This problem has been addressed in W089/06653 (Baxter International Inc). The Baxter disclosure provides a blunt hollow adaptor at the distal end of an extension piece of a vascular placement apparatus so that the hollow adaptor will penetrute a prefolmed channel in the self-sealing septum and thereby form a channel fiom the extension piece to the cannula. The blunt hollow adaptor may be coupled directly to an administration set or via an extension piece, so that any change over in the administlation set, for example to change one fluid for another, does not entail detnchment of the adaptor from the cannula.
The rigid hollow adaptor is prefelably formed of a metal Ol a rigid plastics material. An advantage of this last type of arrangement is that the sub6tantially rigid blunt adaptol prevents needle-stick, 20242~
The arrangen1ent of Baxter includes in a first aspect a thin pre-slit septum which may be penetrated by a blunt hollow adaptol. This arrangement is prone to problems in that after use over a number of engagement and dis-engagement cycle~, the pre-slit disc shaped septum does not nece~fllily close 6 entirely and this allows of the possibility of infection. In the second aspect of the Baxter disclosure there is provided a relutively large blunt hollow adaptor adapted to enter a pre-slit or partially pre-slit septum. The relatively large bore of the blunt adaptor neces~arily causes an amount of collateral damage to the septum particularly when the resilient material of the septum has lost some of its resilience through a~ing.
We have now found that "coring" cun be prevented, or at least reduced to a negligible problem, by providing an entile r esilient septum, preferably associated with an introducer needle which both penetrates the septum, passes down the cflnnllla and acts to assist the introduction of the cannula at the injection site.
Correctly used, the introducer needle will position the channel in the septum at a position, for ex~mple co-axial, where the blunt adaptor will be aligned with axis of the cannula. The pre-forming of the channel in the septum tends to result in mis-tllignr~ent of the channel with the blunt needle.
The performance of this arrangement is signific~ntly improved if the resilient septum is of a bio-compatihle plastic or rubbel material with aging characteristics. As is well known some plastics materials and rubbels, for example natural rubbels, change theil charactelistics with age.
The invention therefore comprehends a resiliellt septum of a natural Ol synthetic resilient material which when initially positioned in in itæ fresh state in the body of the vascular placement apparatus is fully resilient, thereby forming a good seal with the body components. After a given peliod 6 of time, the resilient material nges such that relative hardness thereof is increased.
This allows the blunt hollow adaptor to penetrate the channel formed in septum by the introducer needle without displacing particles into the lumen of the same. The materials f`or the septum may be any synthetic or natural plastics or rubber material~ which include an aging chalacteristic. The aging characteristic is the increase in hardness over a short aging period followed bya long period when the hardness does not signiflcantly change as may be gr~phiçfllly characterised by a 6igmate cul~e. An example of this material is bio conlpfltil~le rubber but other synthetic plastic materials are available with these charactelistics which are readily available to those skilled in the art bysimple practical experimentatiun.
Accordingly the present invention is charactelised in that the self-sealing BeptUm iB formed of a resilient material which ages rapidly after forming to a point where resilience is not significantly further effected by time~ and in that ~0 a channel is formed in the septum when the septum has aged for the said pre-determined period of time.
Preferably the resilient material is a biocompatible natural rubber and the pre-determined period of time is 2-5 weeks, most preferably about 3 weeks. It will be appreciated that the pre-cletelmined pelio~l depends upon the plecise 2a24~
constituentæ of the chosen material. We have found by use of this technique a that blunt hollow adaptor can be introduced into the septum without fi~flnt coling.
In a preferred form the invention the channel is formed l~y an introducel needle us hereinbefore described, in which case the hub a~emhly is most preferably provided with a convergent inner-plofile to guide the intloducel needle point to a position at which it is coaxial with the lumen of the cannula in use.
The hub may be adupted for connection with an extension piece carlyillg said blunt hollow adaptor; the opelative end of the blunt hollow adaptor iB
preferably chSlmpheled to produce a low fiiction surface. The low fiiction eulface muy be achieved by electlonic smoothing Ol by the provi~ion of a low friction coflting, for example "Teflon" (Registered Trade Malk).
One embodiment of the invention will llOW be de~cribed, by way of illustr~tion only, with reference to the accompanying drawillg which shows in plan, and in part cross-æection, in arlangement in accordance to the present invention.
With reference to the drawing a plastics cannula (1) is formed with a hub aæsembly (4) which in this palticulal inætance forms palt of a Luel-lock of known type. The cannula (1) haæ a lumen such that it may be penetrated by an intloducer needle (2) to an extent that the introducel needle (2) extends from the end of the cannul~ (1) in use.
The introducer needle (2) with the cannula (1) disposed thereabout may then be introduced into a blood vessel of a patient. The needle (2) may then be withdrawn leaving the cannula (1) in place.
In accordance with the present invention, a self-sealing septum (3) formed of a bio-compatible natural rubber, is provided within the hub (4) on manufacture. This septum (3) is freshly manufactured before being positioned and is entire (i.e., has no channel therein).
An extension piece shown generally at (6) comprises a blunt hollow adaptor (5) which is interconnected with a Luer-taper (7). The Luer-taper (7) is provided with a Luer lock* element (8) for inter-engagement with a Luer-lock arrangement on the periphery of the hub (4) in conventional fashion. The extension piece (6) is adapted to inter-connect the Luer-lock with a connector (9) remote therefrom for ready inter-connection of an administration set (10) or any other medical apparatus.
In use, the introducer needle (2) is urged through the septum (3) so that it passes along the cannula (1). It will be observed that interior faces of the hub (4) are tapered at (4A) to provide a relatively small "target area" and are still matched to the Luer-taper (7). The withdrawal of the needle (2) when the cannula (1) is located within the blood vessel then leaves the channel in the septum (3) which is sealed by the aged resilient material.
The blunt hollow adaptor (5) may then be introduced into the hub (4) and guided towards the central portion of the septum thereby. The blunt hollow adaptor contacts the septum (3) and an end portion thereof presses on the * a registered trade-mark of Becton, Dickinson and Company 2Q242~
same and enters the channel. The end of adaptor (3) is thus guided into the chflnnel formed by the introducel needle (2) to the extent that continued movement of the Luer-taper (7) towards the septum (3) causes the blunt hollow adaptor (6) to penetrate the septum (3) completely and thereby e~t~hli~h a ~elf-sealed fluid path between the cannula (1) and adapto~ (9)~ The Luer-lock element (8) may then be inter-engaged in the usual way with hub (4) thereby locking the two together.
An advantage of the intravascular placement apparatus in accordance to the present invention is that not only do neither the cannula (1) or the adapto (5) require a sharp point and accordingly the danger of needle stick by this appal'atu6 iB largely speaking obviated, but also the problem of coring is at least s~lhstflnti~lly prevented.
Claims (13)
1. An intravascular placement apparatus adapted for operative association with an introducer needle, said apparatus comprising:
(a) a cannula having a first operative end and a second end remote from said first end, said cannula provided with a connector hub at its remote end, (b) a self-sealing septum having a surface por-tion and a portion interior thereto disposed across the internal lumen of the cannula, whereby the cannula can be positioned by co-operation with the introducer needle, and (c) a blunt hollow adapter adapted to penetrate a channel in the septum;
wherein the self-sealing septum is formed of resilient material, the surface portion of the septum being aged in a first aging step, thereby increasing its hardness, and wherein a channel having a surface in the interior portion of the septum is formed in the aged septum by inserting a needle through the septum after said first aging step, said needle being retained in the aged septum in a second aging step for a predetermined period during which the hardness of the channel surface increases, whereby after withdrawal of the needle following the second aging step the hardness of the surface portion is greater than the hardness of the channel surface and the hardness of the channel surface is greater than the hardness of the internal portion of the septum.
(a) a cannula having a first operative end and a second end remote from said first end, said cannula provided with a connector hub at its remote end, (b) a self-sealing septum having a surface por-tion and a portion interior thereto disposed across the internal lumen of the cannula, whereby the cannula can be positioned by co-operation with the introducer needle, and (c) a blunt hollow adapter adapted to penetrate a channel in the septum;
wherein the self-sealing septum is formed of resilient material, the surface portion of the septum being aged in a first aging step, thereby increasing its hardness, and wherein a channel having a surface in the interior portion of the septum is formed in the aged septum by inserting a needle through the septum after said first aging step, said needle being retained in the aged septum in a second aging step for a predetermined period during which the hardness of the channel surface increases, whereby after withdrawal of the needle following the second aging step the hardness of the surface portion is greater than the hardness of the channel surface and the hardness of the channel surface is greater than the hardness of the internal portion of the septum.
2. An apparatus according to claim 1, wherein the resilient material is a biocompatible natural rub-ber and the predetermined period of the second aging step is 2-5 weeks.
3. An apparatus according to claim 1, wherein the channel is formed by an introducer needle and wherein the connector hub is provided with a convergent profile to guide the introducer needle to a point which is generally coaxial with the lumen of the cannula.
4. An apparatus according to claim 1, wherein the hub is adapted for interconnection with an exten-sion piece carrying said blunt hollow adapter and wherein the adapter has an operative end chamfered to produce a low friction surface.
5. A kit of parts which together form an intravascular placement apparatus comprising:
(a) a cannula having a first operative end and a second end remote from the first end, a con-nector hub formed on the second end;
(b) a self-sealing septum having a surface por-tion and a portion interior thereto disposed across the internal lumen of the cannula;
(c) a blunt hollow adapter adapted to penetrate a channel in the septum;
(d) an introducer needle sized to extend from the first operative end of the cannula when fully passed through the septum in which the needle is disposed; and wherein the self-sealing septum is formed of resilient material, the surface portion of the septum being aged in a first aging step, thereby increasing its hardness, and wherein a channel having a surface in the interior portion of the septum is formed in the aged septum by an elongate element after said first aging step, said element being retained in the aged septum in a second aging step for a predetermined period during which the hardness of the surface of the channel increases, whereby after withdrawal of the needle following the second aging step, the hardness of the surface portion is greater than the hardness of the channel surface and the hardness of the channel surface is greater than the hardness of the internal portion of the septum.
(a) a cannula having a first operative end and a second end remote from the first end, a con-nector hub formed on the second end;
(b) a self-sealing septum having a surface por-tion and a portion interior thereto disposed across the internal lumen of the cannula;
(c) a blunt hollow adapter adapted to penetrate a channel in the septum;
(d) an introducer needle sized to extend from the first operative end of the cannula when fully passed through the septum in which the needle is disposed; and wherein the self-sealing septum is formed of resilient material, the surface portion of the septum being aged in a first aging step, thereby increasing its hardness, and wherein a channel having a surface in the interior portion of the septum is formed in the aged septum by an elongate element after said first aging step, said element being retained in the aged septum in a second aging step for a predetermined period during which the hardness of the surface of the channel increases, whereby after withdrawal of the needle following the second aging step, the hardness of the surface portion is greater than the hardness of the channel surface and the hardness of the channel surface is greater than the hardness of the internal portion of the septum.
6. The apparatus according to claim 1, wherein the resilient material is a biocompatible natural rub-ber and the predetermined period of the second aging step is about 3 weeks.
7. An intravascular placement apparatus having (i) a needle and (ii) a cannula having a self-sealing septum formed from a resilient material, said septum having a surface portion and a portion interior thereto and disposed across the internal lumen of the cannula, said apparatus made by:
(a) forming said septum;
(b) initially aging said surface portion of said septum, thereby increasing its hardness;
(c) inserting said needle through said aged sep-tum, thereby forming a channel having a surface in said interior portion of said septum;
(d) further aging said septum with said needle inserted therein for a predetermined period of time, thereby increasing the hardness of said channel surface, whereby the hardness of the surface portion is greater than the hardness of said channel surface and the hardness of the channel surface is greater than the hardness of said internal portion of said septum; and (e) withdrawing said needle after said predeter-mined period of time.
(a) forming said septum;
(b) initially aging said surface portion of said septum, thereby increasing its hardness;
(c) inserting said needle through said aged sep-tum, thereby forming a channel having a surface in said interior portion of said septum;
(d) further aging said septum with said needle inserted therein for a predetermined period of time, thereby increasing the hardness of said channel surface, whereby the hardness of the surface portion is greater than the hardness of said channel surface and the hardness of the channel surface is greater than the hardness of said internal portion of said septum; and (e) withdrawing said needle after said predeter-mined period of time.
8. The apparatus according to claim 7, wherein said septum is positioned within said cannula before said initial aging step.
9. The apparatus according to claim 7, wherein said resilient material is a biocompatible natural rubber and the predetermined period is in the range of 2-5 weeks.
10. The apparatus according to claim 7, further comprising a hollow adapter for connecting a medical device to said cannula, and wherein said apparatus is further made by inserting a portion of said hollow adapter through said channel after withdrawal of said needle.
11. The apparatus according to claim 7, wherein said septum has no channel formed therein until said needle is inserted therethrough.
12. In an intravascular placement apparatus hav-ing (i) a needle and (ii) a cannula having a self-sealing septum formed from a resilient material disposed across the internal lumen of the cannula, a method of preventing coring of said septum when a hol-low adapter is inserted therethrough, comprising the steps of:
(a) forming said septum and then positioning said septum within said cannula;
(b) aging said septum, thereby increasing its hardness;
(c) inserting said needle through said aged sep-tum, thereby forming a channel therein;
(d) further aging said septum with said needle inserted therein for a predetermined period of time, thereby further increasing the hardness of said septum;
(e) withdrawing said needle after said predeter-mined period of time; and (f) inserting said hollow adapter through said channel in said septum.
(a) forming said septum and then positioning said septum within said cannula;
(b) aging said septum, thereby increasing its hardness;
(c) inserting said needle through said aged sep-tum, thereby forming a channel therein;
(d) further aging said septum with said needle inserted therein for a predetermined period of time, thereby further increasing the hardness of said septum;
(e) withdrawing said needle after said predeter-mined period of time; and (f) inserting said hollow adapter through said channel in said septum.
13. The method according to claim 12, wherein said resilient material is a biocompatible natural rubber and the predetermined period is in the range of 2-5 weeks.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBUK8919728.9 | 1989-08-31 | ||
| GB898919728A GB8919728D0 (en) | 1989-08-31 | 1989-08-31 | Intravascular placement apparatus |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2024285A1 CA2024285A1 (en) | 1991-03-01 |
| CA2024285C true CA2024285C (en) | 1995-08-15 |
Family
ID=10662347
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002024285A Expired - Fee Related CA2024285C (en) | 1989-08-31 | 1990-08-30 | Intravascular placement apparatus |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US5122120A (en) |
| EP (1) | EP0415653B1 (en) |
| AT (1) | ATE104159T1 (en) |
| AU (1) | AU626713B2 (en) |
| CA (1) | CA2024285C (en) |
| DE (1) | DE69008081T2 (en) |
| GB (1) | GB8919728D0 (en) |
| IE (1) | IE65819B1 (en) |
| ZA (1) | ZA906921B (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IE911031A1 (en) * | 1990-04-03 | 1991-10-23 | Knutson Richard A | Closed system intravenous catheter |
| NL1007148C2 (en) * | 1997-09-26 | 1999-03-29 | Cordis Europ | Catheter input sheath. |
| US5976115A (en) * | 1997-10-09 | 1999-11-02 | B. Braun Medical, Inc. | Blunt cannula spike adapter assembly |
| US6936031B2 (en) | 2000-12-12 | 2005-08-30 | Gambro Dasco S.P.A. | Site for access to the inside of a channel, and corresponding cannula |
| US20050075612A1 (en) * | 2003-10-03 | 2005-04-07 | Baxter International Inc. | Parylene coated fluid flow regulator |
| WO2010010870A1 (en) * | 2008-07-25 | 2010-01-28 | 株式会社根本杏林堂 | Medical connector tool |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4046144A (en) * | 1975-09-18 | 1977-09-06 | Mcfarlane Richard H | Catheter placement assembly |
| US4239042A (en) * | 1979-04-05 | 1980-12-16 | Dow Corning K.K. | Catheter placement system |
| US4349023A (en) * | 1980-10-09 | 1982-09-14 | Abbott Laboratories | Epidural needle catheter and adapter |
| DE3229466A1 (en) * | 1982-08-06 | 1984-02-09 | Sterimed Gesellschaft für medizinischen Bedarf mbH, 6600 Saarbrücken | POINTING AND CATHETERIZING DEVICE FOR HUMAN OR ANIMAL BODIES |
| US4547194A (en) * | 1984-03-16 | 1985-10-15 | Moorehead Harvey R | Hub assemblies and extensions for indwelling catheter tubes and method |
| JPS60234671A (en) * | 1984-05-09 | 1985-11-21 | テルモ株式会社 | Catheter inserter |
| US4596557A (en) * | 1984-06-26 | 1986-06-24 | Pexa Charles E | Air eliminator for intravenous tube |
| JPS61131746A (en) * | 1984-11-30 | 1986-06-19 | 塩谷エムエス株式会社 | Stopcock for freeze drying preparation |
| US4705511A (en) * | 1985-05-13 | 1987-11-10 | Bipore, Inc. | Introducer sheath assembly |
| DE3518547C2 (en) * | 1985-05-23 | 1994-04-14 | Angiomed Ag | Hollow needle of a biopsy set |
| US4755173A (en) * | 1986-02-25 | 1988-07-05 | Pacesetter Infusion, Ltd. | Soft cannula subcutaneous injection set |
| GB8618253D0 (en) * | 1986-07-25 | 1986-09-03 | Wallace Ltd H G | Intermittent administration of therapeutic substance |
| US4721506A (en) * | 1986-11-07 | 1988-01-26 | Teves Leonides Y | Flat-inclined tip needle |
| GB8627808D0 (en) * | 1986-11-20 | 1986-12-17 | Cox J A | Sampling liquids from human/animal body |
| US4832696A (en) * | 1987-03-05 | 1989-05-23 | Luther Medical Products, Inc. | Assembly of needle and protector |
| US4772267A (en) * | 1987-03-27 | 1988-09-20 | Menlo Care, Inc. | Peripheral IV catheter with enlargeable flashback chamber |
| US4842591A (en) * | 1988-01-21 | 1989-06-27 | Luther Ronald B | Connector with one-way septum valve, and assembly |
| EP0354947B1 (en) * | 1988-01-25 | 1994-07-20 | BAXTER INTERNATIONAL INC. (a Delaware corporation) | Pre-slit injection site and tapered cannula |
| US4863431A (en) * | 1988-03-03 | 1989-09-05 | Vaillancourt Vincent L | Catheter assembly |
| US4846804A (en) * | 1988-03-24 | 1989-07-11 | Dlp Inc. | Combined needle protector and guidewire feeder |
| US4952207A (en) * | 1988-07-11 | 1990-08-28 | Critikon, Inc. | I.V. catheter with self-locating needle guard |
| US4964854A (en) * | 1989-01-23 | 1990-10-23 | Luther Medical Products, Inc. | Intravascular catheter assembly incorporating needle tip shielding cap |
| US5011473A (en) * | 1989-06-06 | 1991-04-30 | Mitek Surgical Products Inc. | Device for securing and positioning a wire to a needle |
| US4998921A (en) * | 1989-11-20 | 1991-03-12 | Vickroy Harold C | Intermittent I.V. therapy needle sheath |
-
1989
- 1989-08-31 GB GB898919728A patent/GB8919728D0/en active Pending
-
1990
- 1990-08-23 AT AT90309264T patent/ATE104159T1/en not_active IP Right Cessation
- 1990-08-23 IE IE307790A patent/IE65819B1/en not_active IP Right Cessation
- 1990-08-23 EP EP90309264A patent/EP0415653B1/en not_active Expired - Lifetime
- 1990-08-23 DE DE69008081T patent/DE69008081T2/en not_active Expired - Fee Related
- 1990-08-24 AU AU61325/90A patent/AU626713B2/en not_active Ceased
- 1990-08-28 US US07/574,474 patent/US5122120A/en not_active Expired - Fee Related
- 1990-08-30 CA CA002024285A patent/CA2024285C/en not_active Expired - Fee Related
- 1990-08-30 ZA ZA906921A patent/ZA906921B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP0415653B1 (en) | 1994-04-13 |
| ATE104159T1 (en) | 1994-04-15 |
| CA2024285A1 (en) | 1991-03-01 |
| ZA906921B (en) | 1991-11-27 |
| GB8919728D0 (en) | 1989-10-11 |
| IE903077A1 (en) | 1991-03-13 |
| DE69008081D1 (en) | 1994-05-19 |
| US5122120A (en) | 1992-06-16 |
| IE65819B1 (en) | 1995-11-15 |
| EP0415653A2 (en) | 1991-03-06 |
| EP0415653A3 (en) | 1991-04-17 |
| AU626713B2 (en) | 1992-08-06 |
| DE69008081T2 (en) | 1994-07-28 |
| AU6132590A (en) | 1991-03-07 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |