WO1999055405A1 - Vascular infusion device - Google Patents
Vascular infusion device Download PDFInfo
- Publication number
- WO1999055405A1 WO1999055405A1 PCT/US1999/007367 US9907367W WO9955405A1 WO 1999055405 A1 WO1999055405 A1 WO 1999055405A1 US 9907367 W US9907367 W US 9907367W WO 9955405 A1 WO9955405 A1 WO 9955405A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- wall
- distal end
- fluid
- space
- lumen
- Prior art date
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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
-
- 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
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
Definitions
- the present invention relates generally to medical devices suitable for use in delivering fluids to a patient More particularly, the invention relates to an introducer sheath which will include side holes configured such that the holes appear longitudinally and circumferentially along the sheath tubing to provide an outlet for medications injected into the sidearm of the sheath The holes will allow medication to be directed to specific locations rather than to have the entire volume of medication exit the distal end of the sheath tube
- the clinical utility of the infusion sheath relates to the ability to infuse medications, specifically medications intended to counteract vasospasm
- Vasospasm is a common problem, particularly in the transradial cathete ⁇ zation technique
- the result of vasospasm is difficulty in sheath removal and accompanying patient discomfort at the end of a cathete ⁇ zation procedure
- physicians will commonly administer a 'cocktail' of medications
- An example of such a cocktail would be a mixture of Verapamil, Nitroglycerine, and Xylocame, Verapamil being an antispasmotic agent
- This mixture would be injected through the sideport of the sheath, often prior to withdrawing the sheath, to minimize vasospasm and discomfort
- the fluid will exit in its entirety out the end of the sheath With a 21 cm sheath, this presents the potential for the drugs to be significantly distant from where the spasming may be taking place The tendency of the medications
- the infusion sheath design of the present invention overcomes these clinical problems By providing infusion ports along a significant portion of the sheath tubing, the drugs can exit the sheath at the point where spasming may be occurring and have a quicker, and perhaps, more effective response
- Some prior art teachings disclose side holes or slits which communicate with specifically designated lumens within the wall of the sheath
- the present invention allows for a sheath which maintains the c ⁇ tical aspects of being able to have appropriate wall thickness such that insertability and the size of the puncture are not compromised
- the present invention is directed toward a vascular device adapted for infusion of fluids into a patient comprising an elongated tubular member having a proximal end, a distal end and a wall extending between the proximal end and the distal end, the wall having an inner surface and an outer surface, at least one lumen extending between the proximal end and the distal end and communicating with the inner surface, with the at least one lumen being adapted to receive a fluid, and one or more apertures disposed in the wall along a length between the proximal end and the distal end for providing fluid communication between the inner surface and the outer surface and adapted for conveying the fluid between the at least one lumen and an environment surrounding the outer surface
- the apertures might be disposed circumferentially about the wall, as for example, in a helical pattern, or the apertures might be disposed longitudinally along the wall, as for example, in one or more rows
- the apertures may have a diameter in a range of from about 0 025
- the invention further embodies a vascular device for infusion of fluids into a patient comprising a first elongated tubular member having a proximal end a distal end, a first lumen extending therethrough and a first wall having an outer surface and extending between the proximal end and the distal end, a second tubular member having a second wall and being positioned within the lumen to define a space between the first wall and the second wall, the space being adapted to receive a fluid, the second tubular member being sized and configured to create a fluid seal proximate the distal end of the first tubular member, and one or more apertures disposed in the first wall between the proximal end and the distal end for providing fluid communication between the space and an environment surrounding the outer surface of the first wall, wherein fluid introduced into the space exits the device substantially only through the one or more apertures along the length of the outer surface of the first wall
- the apertures might be disposed circumferentially about and longitudinally along the first wall
- the dilator might include at least one groove disposed in an outer surface along a length of the dilator
- the dilator might further comprise a closed distal end and a second lumen therein communicating with the space, the second lumen being adapted to receive the fluid and delivering the fluid to the space
- the second wall of the dilator might comprise one or more second lumens disposed in the second wall communicating with the space, the one or more second lumens being adapted to receive the fluid and delivering the fluid to the space
- the invention still further embodies a vascular device for infusion of fluids into a patient comprising a first elongated tubular member having a proximal end, a distal end and a lumen extending therethrough, a first wall extending between the proximal end and the distal end, with the first tubular member having a through opening at the distal end, a second tubular member having a second wall and being positioned within the lumen to define a space between the first wall and the second wall, the space being adapted to receive a fluid, with a portion of the second member extending through the opening at the distal end of the first tubular member, and one or more apertures disposed in the first wall between the proximal end and the distal end for providing fluid communication between the space and an environment external of the device, wherein a portion of the fluid introduced into the space exits the device through the one or more apertures along the length of the first wall
- the second tubular member is a catheter and the apertures are disposed circumferentially
- Fig 1 is a partial, elevation view of an embodiment of a vascular access device in accordance with the p ⁇ n ⁇ ples of the present invention and illustrating an infusion sheath with side holes for the delivery of fluid into a patient
- Fig 2 is a partial, elevation view of a dilator adapted for use with the access device of
- Fig 3 is a partial, sectional view in elevation of the device of Fig 1 with the dilator of Fig 2 inserted into the infusion sheath
- Fig 3A is an enlarged sectional view of the area signified by 3A of Fig 3
- Fig 3B is an enlarged sectional view of the area signified by 3B of Fig 3
- Fig 4 is an elevation view of a modified dilator
- Fig 4A is an enlarged, cross sectional view of the dilator of Fig 4 taken along sight line 4A-4A
- Fig 5 is a partial, sectional view, in elevation, of the device of Fig 1 with a catheter inserted into the infusion sheath
- Fig 5A is an enlarged sectional view of the area signified by 5A of Fig 5
- Fig 5B is an enlarged sectional view of the area signified by 5B of Fig 5
- Fig 6 is a partial, sectional view, in elevation, of the device of Fig 1 with another modified dilator inserted into the infusion sheath
- Fig 6A is an enlarged sectional view of the area signified by 6A of Fig 6
- Fig 6B is an enlarged sectional view of the area signified by 6B of Fig 6
- Fig 6C is an enlarged sectional view of the area signified by 6C of Fig 6
- Fig 7 is a partial, sectional view, in elevation, of the device of Fig 1 with another modified dilator inserted into the infusion sheath
- Fig 7A is an enlarged, cross sectional view of the device of Fig 7 taken along sight line 7A-7A
- Fig 7B is an enlarged sectional view of the area signified by 7B of Fig 7
- Fig 7C is an enlarged sectional view of the area signified by 7C of Fig 7
- Fig 7D is an enlarged sectional view of the area signified by 7D of Fig 7 Detailed Description of the Preferred Embodiments
- a partial (shortened), elevation view of a first embodiment of a vascular access device 10 The device 10 includes an infusion sheath 12 with distal end portion 12a having a distal end 12b and side holes 14 for the delivery of fluid, such as medicaments into a patient Sheath 12 has a lumen 11 (not shown in this view but shown in at least Fig 3) Fluids or medications might be injected, in the direction as indicated by the dashed line with arrow F, by sy ⁇ nge or the like through a stopcock 16 attached to a sidearm 18 at one end and delivered through sidearm 18 to sheath 12 via attachment of sidearm 18 to a hub 20 located at an end of sheath 12
- holes 14 are located such that infusion will be provided along a substantial length of the sheath 12 tubing that is actually in an artery when the artery is being accessed A gap 13 will exist between the hub 20 and a first hole 14 such that fluid infusion will take place only within a patient's body but generally it will not take place in subcutaneous tissue
- the holes 14 are in communication with the main lumen 11 of the sheath
- the side holes 14 of sheath 12 are extremely small The holes can range from about
- the holes can be displayed in the sheath wall in a variety of ways, for example, circumferentially, helically, or longitudinally Hole sizing is important for at least two design aspects The first is that because of the length of the sheath tubing, typically from about 10 cm to about 25 cm, having larger holes would have the affect of the majority of the fluid exiting the holes proximally located, namely toward hub end 20 The small holes create enough resistance such that it is possible to get very balanced flow out of as many as 17 side holes The holes might be spaced from about 1 mm to about 200 mm apart and suitably about 10 mm apart.
- the second key aspect of the size of these holes is that one cannot compromise the strength of the sheath tubing Sheaths are inherently very thin walled to allow for good insertability and minimal puncture size By putting holes in such a thin wall tubing, there is a likelihood that the strength of the tubing will be compromised This weakness can take
- a dilator 22 as shown in Fig 2 would be suitable for use with device 10
- the dilator of Fig 2 has a first portion or segment comprising a first, enlarged section 24, a second portion or segment comprising a second, reduced section 26, a proximal end portion 28 having a hub 30, and a distal end portion 32 having a distal tip 34
- Fig 3 there is illustrated device 10 with dilator 22 inserted into lumen 11 of sheath 12
- holes 14 of sheath 12 are not shown in this view, it should be understood that the holes are present and they are configured and spaced as provided in connection with the description of Fig 1
- Dilator hub 30 coacts with sheath hub 20 to maintain the position of the dilator within the sheath
- Fig 3A is an enlarged sectional view depicting dilator 22 with a portion of reduced section 26 located in sheath 12 and further depicts space 15 created between outer wall surface 23 of dilator 22 and innerwall surface 25 of sheath
- the diameter of enlarged dilator section 24 is at least equal to lumen 11 at the distal end 12b of sheath 12 and may be slightly larger to create a fluid tight friction seal
- Substantially all introduced fluid F will exit side holes 14 It is important to control the flow of medications in this application Current sheaths do not have infusion side holes and allow for a gap between a catheter inserted through the sheath and the sheath itself This has the benefit of allowing for pressure monitoring or a slow infusion of fluids This gap would allow for some amount of the medication to escape out the distal end of the sheath To prevent this, the aforementioned dilator of the present invention effectively seals off the end of the sheath This forces the medication to flow out the infusion ports rather than the distal end of the sheath
- the outside diameter of a dilator of the present invention effectively seals off the end of the sheath This forces the medication to flow out the infusion ports rather than the distal end of the sheath
- Dilator 22a suitable for use with device 10 in a manner such as that depicted in Fig 3
- Dilator 22a has a first segment comprising a first section 24a, a second segment of reduced section 26a, a proximal end portion 28a having a hub 30a, and a distal end portion 32a having a distal tip 34a
- Second segment 26a includes one or more grooves 38 cut longitudinally therein along outer wall surface 23a of dilator 22a
- Section 26a is sized and configured such that it might have essentially the same outer dimension at 23a as that of lumen 11 , namely the diameter of section 26a at 23a might essentially be the same as the diameter of lumen 11
- grooves 38 would create a space or passageway which would perform the function of space 15 for the passage of fluid
- Dilator 22a further includes a lumen 40 which might be a through lumen, that is, it might pass through distal tip 34a or it might terminate prior to distal tip
- Fig 5 illustrates another embodiment 10a of the invention wherein there is shown a partial (shortened) sectional view, in elevation, of device 10 with a catheter 42 having hub 44 inserted into lumen 11 of infusion sheath 12 As was discussed in respect to Fig 3, although -7-
- Fig 5A is an enlarged sectional view depicting catheter 42 located in sheath 12 and further depicts space 15a created between outer wall surface 43 of catheter 42 and innerwall surface 25 of sheath 12
- Catheter 42 is sized and configured such that it is smaller in cross section than lumen 11 to create space 15a for the passage of fluid around outer wall surface 43
- it is the space 15a which receives fluid F directed through the sidearm 18 and allows, in this embodiment, passage of at least a portion of the fluid through sheath holes 14 (not shown in this view) for delivery of the fluid to the environment surrounding sheath 12
- Fig 5B is an enlarged sectional view depicting distal end portion 12a of sheath 12 and showing catheter 42 passing through distal
- Dilator 46 includes a lumen 48, a closed distal end 50 and one or more holes 52 disposed along the dilator wall 54
- the dilator also includes a hub 30b which is like hub 30, 30a previously mentioned
- fluid F' is typically delivered into lumen 48 at hub 30b for passage through lumen 48 and out holes 52 for delivery to side holes 14 (not shown) of sheath 12 If desired one could deliver fluid through stopcock 16 as disclosed in respect to embodiments of devices 10 and 10a
- Fig 6A is an enlarged sectional view depicting dilator 46 located in sheath 12 and further depicts space 15c created between outer wall surface 23b of dilator 46 and innerwall surface 25 of sheath 12
- Dilator 46 is shown to be sized and configured such that it is smaller in cross section than lumen 11 to create space 15c for the passage of fluid around outer wall surface 23b
- dilator holes 52 are in fluid communication with sheath holes 14
- fluid F would be directed through the sidearm 18 for passage of the fluid through sheath holes 14 (not shown in this view) for delivery of the fluid to the environment surrounding sheath 12
- Fig 6B is an enlarged sectional view depicting distal end portion 12a of sheath 12 and showing a dilator portion 24a much like enlarged dilator portion 24 discussed above
- dilator 46 forms a seal 36a to create a fluid barrier at the distal end of the sheath At -8-
- dilator section 24b is sized to be at least equal to lumen 11 at the distal end 12b of sheath 12 and may be slightly larger to create the fluid barrier
- Fig 6C is an enlarged sectional view showing lumen 48 and closed distal end 50 of dilator 46 All introduced fluid, either F or F', will exit side holes 14
- Fig 7 there is shown yet another embodiment 10c of the invention
- Dilator 56 includes a lumen 40a, an open distal end portion 32b, one or more additional lumens 58 disposed in dilator wall 60, and one or more holes 62 disposed along the dilator wall 60
- the dilator also includes hubs 30c through which fluid F' and F" might be delivered In this embodiment, either fluid F'or F" might be delivered into one or more lumens 58 for passage through lumen(s) 58 and out holes 62 for delivery to side holes 14 (not shown) of sheath 12 Additionally if desired, one could deliver fluid through stopcock 16 as disclosed in respect to embodiments of devices 10 and 10a
- Fig 7A is an enlarged cross sectional view depicting dilator 56 located in sheath 12 and further depicts dilator lumens 40a and 58, opening 62 and space 15d
- Fig 7B shows space 15d created between outer wall surface 23c of dilator 56 and innerwall surface 25 of sheath 12
- Dilator 56 is shown to be sized and configured such that it is smaller in cross section than lumen 11 to create space 15d for the passage of fluid around outer wall surface 23c
- a space would be required and as with the use of the aforementioned embodiments fluid F is directed through the sidearm 18 for passage of the fluid through sheath holes 14 (not shown in this view) for delivery of the fluid to the environment surrounding sheath 12
- a dilator will be snapped into place in the sheath-dilator assembly and the assembly will be used to introduce the sheath into the vessel of a patient as per any standard procedure
- the dilator would be left in place
- the medication would be injected through the stopcock attached to the sidearm of the sheath
- the dilator With the dilator in place and a fluid seal established at the distal end of the sheath, this would allow all or substantially all of the medication to flow out the apertures in the sheath wall
- the dilator would be withdrawn
- the sheath would then used as a conventional sheath and medication would flow primarily through the end of the sheath although some fluid would flow out the side holes If at any time during the procedure the physician wishes to take
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE69918543T DE69918543T2 (en) | 1998-04-24 | 1999-04-23 | VASCULAR INFUSION DEVICE |
EP99921372A EP1073494B1 (en) | 1998-04-24 | 1999-04-23 | Vascular infusion device |
JP2000545600A JP2002512861A (en) | 1998-04-24 | 1999-04-23 | Vascular infusion device |
AT99921372T ATE270570T1 (en) | 1998-04-24 | 1999-04-23 | VASCULAR INFUSION DEVICE |
CA002323567A CA2323567A1 (en) | 1998-04-24 | 1999-04-23 | Vascular infusion device |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/066,223 US6179813B1 (en) | 1998-04-24 | 1998-04-24 | Vascular infusion device |
US09/066,223 | 1998-04-24 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999055405A1 true WO1999055405A1 (en) | 1999-11-04 |
Family
ID=22068098
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1999/007367 WO1999055405A1 (en) | 1998-04-24 | 1999-04-23 | Vascular infusion device |
Country Status (7)
Country | Link |
---|---|
US (1) | US6179813B1 (en) |
EP (1) | EP1073494B1 (en) |
JP (1) | JP2002512861A (en) |
AT (1) | ATE270570T1 (en) |
CA (1) | CA2323567A1 (en) |
DE (1) | DE69918543T2 (en) |
WO (1) | WO1999055405A1 (en) |
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1998
- 1998-04-24 US US09/066,223 patent/US6179813B1/en not_active Expired - Fee Related
-
1999
- 1999-04-23 AT AT99921372T patent/ATE270570T1/en not_active IP Right Cessation
- 1999-04-23 CA CA002323567A patent/CA2323567A1/en not_active Abandoned
- 1999-04-23 EP EP99921372A patent/EP1073494B1/en not_active Expired - Lifetime
- 1999-04-23 DE DE69918543T patent/DE69918543T2/en not_active Expired - Fee Related
- 1999-04-23 WO PCT/US1999/007367 patent/WO1999055405A1/en active IP Right Grant
- 1999-04-23 JP JP2000545600A patent/JP2002512861A/en active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4661094A (en) * | 1985-05-03 | 1987-04-28 | Advanced Cardiovascular Systems | Perfusion catheter and method |
EP0450221A1 (en) * | 1990-04-04 | 1991-10-09 | C.R. Bard, Inc. | Expandable soft tip sheath |
US5380307A (en) * | 1992-09-30 | 1995-01-10 | Target Therapeutics, Inc. | Catheter with atraumatic drug delivery tip |
US5415636A (en) * | 1994-04-13 | 1995-05-16 | Schneider (Usa) Inc | Dilation-drug delivery catheter |
WO1997042998A1 (en) * | 1996-05-10 | 1997-11-20 | Localmed, Inc. | Method and apparatus for pressurized intraluminal drug delivery |
Also Published As
Publication number | Publication date |
---|---|
EP1073494B1 (en) | 2004-07-07 |
DE69918543D1 (en) | 2004-08-12 |
ATE270570T1 (en) | 2004-07-15 |
EP1073494A1 (en) | 2001-02-07 |
JP2002512861A (en) | 2002-05-08 |
CA2323567A1 (en) | 1999-11-04 |
DE69918543T2 (en) | 2005-07-28 |
US6179813B1 (en) | 2001-01-30 |
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