NZ621749B2 - A catheter having a pressure activated splittable feature - Google Patents
A catheter having a pressure activated splittable feature Download PDFInfo
- Publication number
- NZ621749B2 NZ621749B2 NZ621749A NZ62174912A NZ621749B2 NZ 621749 B2 NZ621749 B2 NZ 621749B2 NZ 621749 A NZ621749 A NZ 621749A NZ 62174912 A NZ62174912 A NZ 62174912A NZ 621749 B2 NZ621749 B2 NZ 621749B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- catheter
- tip
- adapter
- distal
- lumen
- Prior art date
Links
- 239000012530 fluid Substances 0.000 claims description 38
- 230000002792 vascular Effects 0.000 claims description 38
- 238000001990 intravenous administration Methods 0.000 claims description 23
- 210000003462 Veins Anatomy 0.000 claims description 18
- 230000002093 peripheral Effects 0.000 claims description 12
- 238000004891 communication Methods 0.000 claims description 5
- 210000000614 Ribs Anatomy 0.000 claims description 4
- 239000000463 material Substances 0.000 claims description 4
- 230000001131 transforming Effects 0.000 claims 3
- 210000001138 Tears Anatomy 0.000 claims 1
- 238000001802 infusion Methods 0.000 description 27
- 238000000034 method Methods 0.000 description 19
- 150000002500 ions Chemical class 0.000 description 11
- 239000002872 contrast media Substances 0.000 description 10
- 229940039231 CONTRAST MEDIA Drugs 0.000 description 9
- 238000003780 insertion Methods 0.000 description 7
- 239000007924 injection Substances 0.000 description 5
- 230000001133 acceleration Effects 0.000 description 4
- 238000009792 diffusion process Methods 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 210000004369 Blood Anatomy 0.000 description 3
- 210000003491 Skin Anatomy 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 238000002591 computed tomography Methods 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 238000002560 therapeutic procedure Methods 0.000 description 3
- 238000002405 diagnostic procedure Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000001764 infiltration Methods 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- -1 polypropylene Polymers 0.000 description 2
- 238000005086 pumping Methods 0.000 description 2
- 210000001519 tissues Anatomy 0.000 description 2
- 230000037227 Blood Loss Effects 0.000 description 1
- 208000001380 Diabetic Ketoacidosis Diseases 0.000 description 1
- 206010015866 Extravasation Diseases 0.000 description 1
- 206010051283 Fluid imbalance Diseases 0.000 description 1
- 206010033645 Pancreatitis Diseases 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000004793 Polystyrene Substances 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- GUTLYIVDDKVIGB-UHFFFAOYSA-N cobalt Chemical compound [Co] GUTLYIVDDKVIGB-UHFFFAOYSA-N 0.000 description 1
- 239000010941 cobalt Substances 0.000 description 1
- 229910052803 cobalt Inorganic materials 0.000 description 1
- 230000003247 decreasing Effects 0.000 description 1
- 238000002059 diagnostic imaging Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000036251 extravasation Effects 0.000 description 1
- 229920005570 flexible polymer Polymers 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 230000003902 lesions Effects 0.000 description 1
- 238000010297 mechanical methods and process Methods 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 235000016236 parenteral nutrition Nutrition 0.000 description 1
- 230000002572 peristaltic Effects 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 229910000811 surgical stainless steel Inorganic materials 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- 238000011144 upstream manufacturing Methods 0.000 description 1
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
- A61M2025/0188—Introducing, guiding, advancing, emplacing or holding catheters having slitted or breakaway lumens
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
-
- 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
- A61M25/0662—Guide tubes
- A61M25/0668—Guide tubes splittable, tear apart
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Abstract
catheter (114,214,314,414) having a catheter body (220,320,420) with a lumen (322,422) and a distal lumen opening (242,342,442). The catheter's lumen extends through the catheter body along a longitudinal axis of the catheter body. A splittable feature (250,350,450) is formed within a wall of the catheter body. catheter body.
Description
A CATHETER HAVING A PRESSURE ACTIVATED
SPLITTABLE FEATURE
BACKGROUND
Vascular access devices are used for communicating fluid with the anatomy of a patient. For
example, vascular access devices, such as ers, are commonly used for infusing fluid, such
as saline solution, various medicaments, and/or total parenteral nutrition, into a patient, withdrawing
blood from a patient, and/or monitoring various ters of the patient’s vascular system.
A variety of clinical circumstances, including massive , major surgical procedures, massive
burns, and certain disease states, such as pancreatitis and diabetic ketoacidosis, can produce
profound circulatory volume ion. This depletion can be caused from actual blood loss or
from internal fluid imbalance. In these clinical settings, it may be necessary to infuse blood and/or
other fluid rapidly into a t to avert serious consequences.
Additionally, the ability to inject large quantities of fluid in a rapid manner may be desirable for
certain other medical and diagnostic procedures. For example, some diagnostic imaging procedures
e contrast media enhancement to improve lesion conspicuity in an effort to increase early
diagnostic yield. These procedures itate that Viscous contrast media be injected by a
specialized “power injector” pump intravenously at very high flow rates, which establishes a st
bolus or small plug of st media in the bloodstream of the patient which results in enhanced
image quality.
Power injection procedures generate high pressures within the infusion system, y requiring
some specialized vascular access devices, extension sets, media transfer sets, pump syringes, and bulk
or pre—fllled contrast media syringes. As the concentration (and thereby viscosity) and on rate
of the contrast media are increased, bolus y also increases resulting in better image y via
computed tomography (CT) attenuation. Therefore, a current trend in healthcare is to se the
bolus density of the contrast media by increasing both the concentration of the contrast media and
the rate at which the media is infused into the patient, all of which ultimately drives system
pressure requirements higher.
Intravenous infusion rates may be defined as either routine, generally up to 999 cubic
centimeters per hour (cc/hr), or rapid, generally between about 999 cc/hr and 90,000 cc/hr (1.5
liters per minute) or higher. For some diagnostic ures utilizing viscous contrast media, an
injection rate of about 1 to 10 ond is needed to ensure sufficient bolus concentration.
Power injections of viscous media at this injection rate produce significant
~Page l-
back pressure within the infusion system that commonly results in a failure of the infusion system
components.
Traditionally, rapid infiision therapy entails the use of an enous catheter attached to a pump,
such as a peristaltic pump, and a fluid source. A patient is infused as a tip portion of the catheter
is inserted into the vasculature of a patient and the pump forces a fluid through the er and
into the patient’s vein. Current rapid on therapies utilize a catheter and catheter tip with
geometries identical to those used with traditional, routine infusion rates. These geometries may
include a tapering catheter tip such that the fluid is accelerated as the fluid moves through the
catheter tip and exits into a patient’s vasculature. This acceleration of the d fluid is
undesirable for several reasons.
For example, the tapered er results in a greater backpressure for the remainder of the catheter
assembly. This effect is undesirable due to the limitations of the pumping capacity of the
infusion pump as well as the limited structural integrity of the components and subcomponents
of the infusion system. For example, if the backpressure becomes too great, the pump’s efficiency
may decrease and certain seals or connections within the infusion system may fail.
Additionally, the fluid ration in the catheter tip results in a recoil force that may cause the
catheter tip to shifi within the patient’s vein thereby displacing the catheter and/or ng the
patient’s vein and/or ion site. Fluid acceleration also increases the jet velocity of the
infilsate at the tip of the catheter. In some procedures, the fluid jet may pierce the patient’s vein
wall thereby leading to extravasation or infiltration. Not only is this uncomfortable and painful to
the t, but infiltration may also prevent the t from receiving the needed therapy.
To overcome undesirable backpressures and increased acceleration of infused fluids, some
intravascular systems include arrays of diffusion holes provided in and around the tip portion of
the intravenous catheter. In general, diffusion holes increase the surface area of the catheter tip
opening thereby decreasing fluid pressure at the catheter tip opening. However, addition of
diffusion holes at or near the tip of a catheter also reduces buckling resistance of the catheter
thereby making the er tip more susceptible to ng during insertion. As a result, the
addition of diffuser holes may result in failed catheterization and physical pain to the patient.
Further, addition of diffuser holes provides the catheter with a ntinuous outer e that
may snag or catch on the g of the patient’s skin and/or vein through which the catheter is
inserted. This too may result in failed catheterization, physical pain and/or physical damage to the
patient.
-Page 2—
Thus, while methods and s currently exist to reduce exit velocity of an infusate during rapid
infusion procedures, challenges still exist. Accordingly, it would be an improvement in the art to
augment or even replace t techniques with other techniques.
BRIEF SUMMARY OF THE ION
The systems and methods of the present sure have been developed in se to problems
and needs in the art that have not yet been fully resolved by currently available infusion systems
and methods. Thus, these systems, components, and methods are developed to provide for safer and
more efficient rapid infusion procedures.
One aspect of the invention provides an improved vascular access device for use in
combination with a vascular infusion system capable of rapidly delivering an infusate to the
vascular system of a t. Some ments of the invention can be configured as follows.
The vascular access device can include an enous catheter configured to access the vascular
system of a patient. The intravenous catheter can have a lumen extending therethrough along a
longitudinal axis to a distal lumen opening. The tip n can comprise a tapered portion,
wherein the outer and inner surface of the tip taper towards the distal end of the er. The
tapered portion of the intravenous catheter can be modified to e a splittable feature
formed though a wall of the catheter body, wherein upon the lumen of the catheter being
subjected to increased fluid pressure, the splittable feature is enabled thereby increasing the
effective area of the catheter’s distal opening.
In another aspect of the invention, a catheter has a catheter body, which has a lumen and a
distal lumen opening. The lumen can extend through the catheter body along a longitudinal
axis of the catheter body to the distal lumen opening. The catheter can also have a splittable
feature formed through a distal tapered portion of the catheter body. In some
implementations, the splittable feature is a line of perforation holes. In other implementations,
the splittable feature is a skive line.
In yet another aspect of the invention, a peripheral catheter includes a catheter body that has a
lumen and a distal lumen opening. The lumen extends h the catheter body along a
longitudinal axis of the catheter body. In some implementations of the present invention, the catheter
body has a truncated length sufficient to access a peripheral vein of a t, and the catheter body is
sized smaller than or equal to a fourteen gauge catheter. A splittable e is formed through a
distal, tapered portion of the catheter body.
Further, in some implementations of the present invention a method for manufacturing a
catheter having a splittable feature is provided. The steps of the method include providing a
catheter body having an outer surface, an inner e, a proximal end, a distal end, a lumen
-Page 3—
extending between the proximal and distal ends along a longitudinal axis of the catheter body,
and a distal lumen opening; providing a catheter tip forming a portion of the distal end, the catheter
tip including the distal lumen opening; and providing a splittable feature formed within a wall of the
catheter tip.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
In order that the manner in which the above-recited and other es and advantages of the
invention are obtained will be readily understood, a more particular description of the ion
briefly described above will be rendered by reference to specific embodiments thereof which are
illustrated in the appended drawings. These gs depict only typical embodiments of the
invention and are not therefore to be considered to limit the scope ofthe invention.
Figure 1 is a perspective View of an infusion system in accordance with a representative
embodiment ofthe present ion.
Figure 2 is a detailed perspective view of a catheter with slits of its distal end in accordance with a
representative embodiment of the t invention.
Figure 3 is a perspective View ofa catheter tip having slits and an introducer needle extending
therethrough in accordance with a representative embodiment of the present invention.
Figure 4 is a cross section end View of a cannula and catheter prior to fluid on in
accordance with a representative embodiment ofthe t invention
Figure 5 is a perspective side view of a er tip following fluid infusion in ance with a
representative embodiment of the present invention.
Figure 6 is a cross section end view of the catheter tip of figure 5 in ance with a
representative embodiment of the present invention.
Figure 7 is a perspective side view of a cannula and catheter prior to fluid on in
accordance with a representative embodiment ofthe present invention.
Figure 8 is a cross n view of the catheter tip of Figure 7 in accordance with a
representative embodiment ofthe present invention.
Figure 9 is a cross section end view of the catheter tip of Figure 8 ing removal ofthe a
and following fluid infusion in accordance with a representative embodiment of the present
invention.
DETAILED DESCRIPTION OF THE INVENTION
Embodiments of the present invention will be best understood by nce to the drawings,
wherein like reference numbers indicate identical or functionally similar elements. It will be
readily understood that the components of the present invention, as generally described and
illustrated in the figures herein, could be arranged and designed in a wide vaiiety of different
-Page 4-
configurations. Thus, the following more detailed description, as represented in the figures, is
not intended to limit the scope of the invention as claimed, but is merely representative of presently
preferred embodiments ofthe invention.
The systems and methods of the present invention are lly designed for use in
combination with a vascular infilsion system capable of rapidly delivering an te to the vascular
system of a patient. Referring now to Figure l, a vascular infusion system 100 is shown, in
accordance with a representative ment of the present invention. Infusion systems of this
type are commonly configured to operate at internal res up to 2000 psi. Many systems
operate in the range of 75 to 2000 psi, while specific devices of this type operate at 100, 200, and
300 psi. The vascular infusion system 100 comprises a vascular access device 112 coupled to an
injector pump 120 via a coiled extension set 130. In some embodiments, the on system 100
further comprises a safety device 140 positioned between the vascular access device 112 and the
injector pump 120. In some embodiments, a safety device 140 is ed to automatically occlude
the fluid path of the infilsion system 100, thereby preventing excessive pressure buildup in
downstream on components.
An injector pump 120 generally comprises a fluid pumping apparatus configured to rapidly deliver an
infusate, such as blood, medicaments, and CT scan contrast agents to a patient’s vascular system.
ble infusates may also include various fluids often of high viscosity as required for
medical and diagnostic procedures. In some embodiments, the or pump 120 comprises a
about 10 mL/hour
power or capable of ring an infilsate to a patient at flow rates from
is desirable
up to greater than 1500 mL/minute. In some embodiments, a high on flow rate
for medical procedures which require enhanced bolus y of an infusate in a patient’s
vascular system. For example, a trend in stic imaging procedures is to utilize contrast
media enhancement, which requires more viscous contrast media to be pushed into a patient at a
higher flow rate, thereby resulting in increased image quality. Thus, in some embodiments an
injector pump 120 and a vascular access device 112 are selected to compatibly achieve a desired
infusion flow rate.
A coiled extension set 130 generally ses flexible or semi-flexible polymer tubing
configured to deliver an infusate from the or pump 120 to the vascular access device 112.
The extension set 130 includes a first coupler for connecting the extension set 130 to a
downstream device 112 or 140. The extension set 130 also includes a second coupler 134 for
connecting the ion set 130 to the injector pump 120. A coiled configuration of the extension
set 130 generally prevents undesirable kinking or occlusion of the set 130 during
-Page 5-
on procedures. However, one of skill in the art will appreciate that the extension set 130
infusate from an injector
may include any configuration capable of efficiently delivering an
pump 120 to the patient via a vascular access device 112. In some embodiments, the
extension set 130 is coupled between a syringe and a vascular access device whereby an
infusate is manually injected into a patient. In other embodiments, the infusion system comprises
only a syringe and a ar access , in accordance with the t invention.
The vascular access device 112 generally comprises a peripheral intravenous catheter 114. A
peripheral intravenous catheter 114 in accordance With the present invention generally comprises a
short or truncated catheter (usually 13mm to 52mm) that is inserted into a small peripheral vein.
Such catheters generally comprise a diameter of approximately a 14 gauge catheter or smaller.
Peripheral intravenous catheters 114 are typically designed for temporary ent. The short length
of the catheter 114 facilitates ient placement of the catheter but makes them prone to
premature dislodging from the vein due to movement of the patient and/or recoil forces
experienced during infusion procedures. Furthermore, unlike midline or central peripheral
catheters, peripheral intravenous catheters 114 in accordance with the present ion comprise
a tapered catheter tip 146 to accommodate use with an introducer needle (not shown) designed to aid
in insertion ofthe catheter 114.
The tapered outer surface of the catheter tip 146 can provide a smooth transition between the narrow
diameter of the er tip opening and the larger diameter of the catheter tubing. Thus, as the
tip 146 of the er 114 is introduced into the vein of a patient, the tapered outer surface 146
facilitates easy insertion of the catheter 114 through the access hole. The tapered inner surface
is generally provided to tightly contact the outer e of an introducer needle housed within the
lumen of the catheter. The introducer needle is provided to create an opening into the vein of
patient through which the catheter tip is inserted. The tapered inner e ensures a tight seal
between the inner surface of the catheter and the outer surface of the needle. ing placement
ofthe catheter, the introducer needle is removed.
An introducer needle is lly inserted through the catheter 114 such that a tip of the needle
extends beyond the d tip 146. The tapered geometry of the tapered tip 146 conforms
tightly to the outer surface of the introducer needle. Both the outer surface and the inner
surface of the tip 146 are tapered towards the distal end of the catheter 114. The outer surface of
the tip 146 is tapered to provide a smooth transition from the smaller profile of the ucer
needle to the larger profile of the catheter outer diameter. ion of the
introducer needle into the vein of the patient es an opening into the vein through which the
—Page 6—
tapered tip 146 of the catheter 114 is inserted. The tapered outer surface of the tip 146 enables easy
ion of the catheter 114 into the opening. Once the peripheral intravenous catheter 114 is
inserted into the vein of the patient, the introducer needle (not shown) is removed from the
lumen ofthe catheter 114 to permit infusion via the catheter 114.
In some embodiments, an inner surface of the tip 146 is tapered to provide a secure seal between
the inner surface of the catheter tip 146 and the outer surface of the ucer needle (not
shown). Additionally, the tapered inner surface of the tip 146 causes an acceleration of
infusate within the lumen of the catheter as the infusate nears and flows through the catheter tip
146. ing an on procedure, the peripheral intravenous catheter 114 is simply removed
from vein and discarded.
A desired infusate is typically delivered to the catheter 114 via a section of intravenous tubing
116 coupled to the catheter 114. In some embodiments, a y-adapter 118 is d to an end of
the tubing 116 opposite the catheter 114, enabling the vascular access device 112 to be coupled to
the remainder of the vascular infusion system 100. One of skill in the art will appreciate the possible
variations and specific features of available vascular access devices 112, as are commonly used
in the medical and research professions. For example, in some embodiments a er 114 in
accordance with the present invention may include additional access sites, clamps, parallel
intravenous lines, valves, couplers, introducer needles, coatings, and/or materials as desired to fit a
specific application.
Referring now to Figure 2, a catheter 214 is shown in accordance with a representative
embodiment of the present invention. Catheter 214 generally comprises a catheter adapter 218
configured to house a tubular body member 220. Catheter adapter 218 further includes an inlet
port 230 that is coupled to a section of intravenous tubing 216. The section of intravenous
tubing 216 is further coupled to upstream on components, as shown and described in
connection with Figure 1, above.
The catheter adapter 218 facilitates delivery of an infilsate within the enous tubing 216 to a
patient via the tubular body member 220. An inner lumen of the catheter r 218 is in
fluid communication with both an inner lumen of the intravenous tubing 216 and an inner lumen
ofthe tubular body member 220. In some embodiments, catheter r 218 further comprises an
access r 222. The access r 222 is generally ed to permit direct access to the
inner lumen of the er adapter 218. In some embodiments, the access adapter 222 is
accessed via a needle and a e to deliver an te to a patient via the tubular body
member 220. In other embodiments, an introducer needle or
guide wire is inserted into the access adapter 222 and advanced through the inner lumen of the
-Page 7—
tubular body member 220. In some embodiments, a tip portion of the ucer needle or guide
wire (not shown) extends beyond a tip portion 240 of the tubular body member 220. As such,
the tip portion of the introducer needle or guide wire may provide an opening into the vascular
system of a patient into which the tubular body member 220 is inserted. Following placement of
the tubular body member 220 into the vein of the patient, the introducer needle or guide wire is
removed from the access adapter 222 thereby establishing fluid communication between the tubular
mber 220, the catheter adapter 218 and the intravenous tubing 216.
In some embodiments, the tubular body member 220 is an intravenous catheter (or catheter
body). The intravenous catheter 214 generally comprises a flexible or semi— flexible
biocompatible material, as commonly used in the art. In some embodiments, the intravenous
catheter 214 comprises a polymer material, such as polypropylene, polystyrene, polyvinylchloride,
polytetrafluoroethylene, and the like. In other embodiments, the intravenous catheter 214
comprises a metallic material, such as surgical steel, titanium, cobalt steel, and the like.
The tubular body member 220 may comprise any , where the length is selected based on
the ed application of the catheter 214. For some applications, the tubular body member
220 is inserted into a peripheral vein of the patient. In other applications, the tubular body member
220 is inserted into a central vein ofthe patient.
For rapid infusion applications, the tip portion 240 of the tubular body member 220 is
modified to include a splittable feature 250. Splittable feature 250 generally allows the
er tip 240 to open up or split apart when an infusate is injected through catheter 214 at
high pressure. As such, the tapered inner and outer surface geometries of catheter tip 240 are
expanded thereby eliminating any geometric constriction that would otherwise se the
flow velocity g the distal g 242 of the tubular body member’s lumen.
Accordingly, for some embodiments the force needed to open splittable feature 250 is less than
the force exerted on catheter tip 240 by the te during high pressure infusion procedures.
In some embodiments, able feature 250 comprises a closed on prior to being inserted
into the vasculature of a patient, as shown in Figure 2. The closed position of splittable feature
250 enables effective insertion of venous catheter 214, as discussed above. In particular, the
closed position ensures that a close nce is maintained between distal opening 342 and an
outer surface of the introducer needle 304, as shown in Figure 3. Thus,
er tip 340 is able to be easily ed into the patient’s vasculature via an opening
provided by the introducer needle. Further, the absence of large ion holes provides a
continuous outer surface for tubular body 320, thereby preventing any snagging or catching of
r body 320 on the skin or other tissues of the patient during catheterization. Still further,
-Page 8-
the absence of large diffusion holes maintains the structural rigidity of catheter tip 340, thereby
preventing any undesirable crushing or collapsing of catheter tip 340 during the catheterization
procedure.
With continued reference to Figures 3 and 4, in some ments splittable feature 350
divides catheter tip 340 into a plurality of adj acent fingers or sections 343. When in the closed
position, as shown, the plurality of adjacent fingers 343 are connected via splittable feature 350
thereby forming the closed er tip 340. In some embodiments, splittable feature 350
comprises a line of perforation openings or holes interposed between adjacent fingers 343. A
space 352 between adjacent proximal and distal openings is selected so as to facilitate tearing
or separation of the catheter tip material between nt proximal and distal openings.
Accordingly, when subjected to increased pressures within catheter body lumen 322, splittable
features 350 separate thereby assuming an open position which forms a plurality of separated,
nt fingers 343, as shown in Figures 5 and 6.
In some embodiments, splittable features 350 are y oriented, and therefore
approximately parallel to a longitudinal axis 305 of catheter 314. In the open position, the plurality
of separated fingers 343 e the effective area of distal catheter opening 342 by providing a
plurality of extended slits or tapered openings through which an infusate 324 exits lumen 322.
Once the splittable features 350 have been ted, any ric or structural constriction of tip
340 are eliminated. As such, inner lumen pressures caused by infusate 324 are reduced and/or
eliminated, thereby producing laminar, low pressure flow of infusate 324 through tubular body 320
and catheter tip 340.
In some embodiments, splittable feature 450 comprises a plurality of skive lines formed on an
inner surface of the tip portion 440 of tubular body 420 of catheter 414, as shown in s 7-9. In
some embodiments, splittable feature 450 is provided so as to divide catheter tip 440 into a
plurality of adjacent fingers or sections 443. By locating splittable feature 450 on the inner
surface of er tip 440, tip 440 ins a continuous outer surface y preventing any
snagging or catching of catheter tip 440 on the skin or tissues of the patient during insertion of the
catheter into the vasculature of the patient. However, in some embodiments splittable feature 450
comprises a ity of skive lines formed on an outer surface of tip portion 440. r, in
some embodiments splittable feature 450 comprises
one or more skive line or lines formed on either the outer e, the inner surface, or both the
outer and inner surfaces oftip portion 440.
When in the closed position, as shown in Figures 7 and 8, the plurality of adjacent fingers 443
-Page 9-
are connected via splittable feature 450 thereby forming the closed catheter tip 440. As such,
splittable feature 450 forms a plurality of grooves 452 axially ed, and ore approximately
parallel to a longitudinal axis 405 of catheter 414. In some embodiments, the axial orientation
of grooves 452 es a ity of axially oriented ribs or splines 454 which facilitate a
more laminar fluid flow of the infusate through catheter lumen 422. Further, in some embodiments
grooves 452 provide an increased effective inside diameter of catheter tip 440. Each of these features,
alone or in combination reduces turbulent flow of the infusate, thereby encouraging laminar flow
and increasing the effective rate of flow for the infusate.
An apex of each groove 452 comprises a thin webbing of er material having a thickness
selected such that the thin webbing is defeated in response to increased pressure within catheter
body lumen 422 during high pressure and/or high velocity infusion procedures. When defeated,
splittable feature 450 divides catheter tip 440 into a plurality of separated, adjacent fingers 443
thereby enlarging the effective surface area of distal catheter opening 442 by providing a
plurality of extended slits or tapered gs 446 through which an infusate 424 exits lumen
422, as shown in Figure 9.
able features ofthe present invention may include any structure, geometry, mechanical function
or other mechanism whereby to ate a constrictive structure of a catheter tip by expanding
the effective area of the distal end g when exposed to an increased inner lumen pressure. For
example, splittable features in accordance with the present invention may include non-linear
configurations, as taught in United States Patent Application Serial No.2 13/053,495,
incorporated herein by reference.
Splittable features in ance with the t invention may include ered points of
weakness within the catheter body and/or catheter tip that are designed to be defeated in
response to increased inner lumen pressure during infusion procedures. In some
embodiments, a catheter comprises a single able feature. In other embodiments, a catheter
comprises two or more splittable features. Accordingly, when subjected to increased inner lumen
pressure, some catheters ofthe present invention provide a single finger wherein a single splittable
feature is defeated thereby g a single ed slit or tapered opening h which an
infusate exits the lumen of the catheter. In other embodiments, when subjected to increased
inner lumen pressure, some catheters of the present invention
provide two or more adjacent fingers, wherein two or more splittable features are ed thereby
forming two or more extended slits or tapered openings through which an infusate exits the
lumen ofthe catheter.
In general, splittable features of the present ion are designed to comprise sufficient
—Page 10-
structural integrity to maintain the closed position of the catheter tip during insertion of the catheter
into the vasculature of the patient. In ular, able features of the present invention are
provided which are capable of withstanding compressive forces exerted on the catheter tip
during insertion into the patient. However, splittable features of the present invention are further
ed to be defeated when exposed to increased inner lumen pressures within the tip portion
ofthe catheter under a high pressure application.
Catheters comprising splittable es in accordance with the present invention may be
ed by any known methods in the art. In some embodiments, splittable features of the
present invention are provided by molding the splittable feature into the catheter tubing during the
tip forming process. For example, able features of the present invention may be provided by
an injection g process, use of mechanical processes, and/or via use of a laser. In
ular, a desired geometry for making the splittable feature can be included in a tipping
mandrel, a tipping die, or both, as well as within the core pin, mold cavity, or both, used to produce
and/or manufacture the catheter device.
The present invention may be embodied in other specific forms without departing from its
structures, methods, or other essential characteristics as broadly bed herein and claimed
hereinafter. The described embodiments are to be considered in all respects only as illustrative,
and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather
than by the foregoing description. All changes that come within the meaning and range of
lency of the claims are to be embraced within their scope.
-Page ll-
Claims (14)
1. A vascular access device, comprising: a catheter r having an access adapter, an inlet port, and a n of intravenous tubing having a first end that is coupled to the inlet port and a second end that is coupled to an adapter, the adapter being configured to connect the catheter r to an injector pump; a catheter extending from a distal end of the catheter adapter, the catheter sing: a catheter body having an outer e, an inner surface, a proximal end, a distal end, a lumen extending between the proximal and distal ends along a longitudinal axis of the catheter body, and a distal lumen g, the lumen of the catheter body being in fluid communication with the access adapter and the inlet port of the catheter adapter; a er tip forming a portion of the distal end, the catheter tip including the distal lumen opening; and a splittable feature formed within a wall of the catheter tip, the splittable feature comprising a ity of skive lines formed along an inner surface of the wall, each of the plurality of skive lines extending sufficiently into the inner surface of the wall so that, when the fluid is injected by the pump through the lumen while the catheter tip is inserted into the vasculature of a patient, the pressure applied on the inner surface by the fluid causes the skive lines to split thereby transforming the catheter tip into a plurality of separated ; and an introducer needle extending through the access adapter of the catheter adapter and through the lumen of the catheter such that a tip of the introducer needle extends out through the distal lumen opening of the catheter tip, an inner diameter of the catheter tip conforming tightly to an outer surface of the introducer needle.
2. The vascular access device of claim 1, wherein the splittable feature comprises three or more skive lines such that the catheter tip is transformed into three or more separated fingers by the pressure applied on the inner e ofthe wall by the fluid.
3. The vascular access device of claim 1, wherein the splittable feature finther comprises one or more skive lines formed along an outer surface ofthe wall. -Page 12-
4. The vascular access device of claiml further comprising: one or more axial ribs or splines formed along the inner surface of the wall.
5. A ar access device comprising: a catheter adapter having an access adapter, an inlet port, and a section of intravenous tubing having a first end that is coupled to the inlet port and a second end that is d to an adapter, the adapter being configured to connect the catheter adapter to an injector pump; a catheter extending fiom a distal end ofthe catheter adapter, the catheter comprising: a catheter body having an outer surface, an inner surface, a proximal end, a distal end, a lumen extending between the proximal and distal ends along a longitudinal axis of the catheter body, and a distal lumen opening, the lumen of the catheter body being in fluid communication with the access adapter and the inlet port of the catheter adapter ; a catheter tip forming a portion of the distal end, the catheter tip ing the distal lumen opening;and a splittable feature formed within a wall of the catheter tip, the splittable feature comprising a plurality of lines of perforation openings, each perforation opening in a line being ted from r proximally or distally positioned ation opening in the line by a space of catheter tip material, the space being configured to tear due to an increased pressure applied against an inner surface of the wall by the fluid when the fluid is injected by the pump through the er tip while the catheter tip is ed into the vasculature of a patient thereby transforming the catheter tip into a plurality of separated fingers; and an introducer needle extending through the access r of the catheter r and through the lumen of the catheter such that a tip of the introducer needle extends out through the distal lumen opening of the catheter tip, an inner diameter of the catheter tip conforming tightly to an outer surface ofthe introducer needle.
6. The vascular access device of claim 5, wherein the splittable feature ses three or more lines of perforation openings such that the catheter tip is transformed into three or more separated fingers by the pressure applied on the inner surface of the wall by the fluid. —Page 13-
7. The vascular access device of claim 5, wherein the splittable feature ses six or more lines of perforation openings such that the catheter tip is ormed into six or more separated fingers by the pressure applied on the inner surface of the wall by the fluid.
8. The ar access device of claim 5, further comprising: one or more axial ribs or splines formed along the inner surface of the wall.
The vascular access device of claim 5, wherein at least some of the perforation openings extend completely through the wall ofthe er tip.
10. The vascular access device ofclaim 5, wherein each ofthe perforation openings extends completely through the wall of the catheter tip.
11. A vascular access device comprising: a catheter r having an access adapter, an inlet port, and a n of intravenous tubing having a first end that is coupled to the inlet port and a second end that is coupled to an adapter, the adapter being red to connect the catheter r to an injector pump; a catheter extending from a distal end of the catheter adapter, the catheter comprising: a er body having a proximal end, a distal end, a lumen extending from the distal end to the proximal end, and a distal lumen g, the catheter body further having a truncated length sufficient to access a peripheral vein of a patient, the catheter body being sized smaller than or equal to a fourteen gauge catheter, the lumen of the catheter body being in fluid communication with the access adapter and the inlet port of the catheter adapter, a splittable feature formed through a distal, tapered portion of the catheter body, the splittable e comprising a plurality of skive lines extending sufficiently into an inner surface of the distal, tapered portion so that, when the fluid is injected by the pump through the distal, tapered portion while the , tapered portion is inserted into the vasculature of a t, the pressure applied on the inner surface by the fluid causes the skive lines to split thereby transforming the distal, tapered portion into a plurality of separated fingers; and an introducer needle extending through the access adapter of the catheter adapter and through the lumen of the catheter such that a tip of the introducer needle extends out through the distal lumen opening of the catheter tip, an inner diameter of the catheter tip conforming tightly to an outer surface of the introducer needle. -Page 14-
12. The vascular access device of claim 11, wherein the able feature comprises three or more skive lines such that the , tapered portion is transformed into three or more separated fingers by the pressure applied on the inner e of the wall by the fluid.
13. The vascular access device of claim 11, wherein the splittable feature further comprises one or more skive lines formed along an outer surface of the distal, tapered portion.
14. The vascular access device of claim 11, further comprising: one or more axial ribs or splines formed along the inner surface of the distal, tapered portion. -Page 15- WO 28348
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/216,029 US9056182B2 (en) | 2011-08-23 | 2011-08-23 | Catheter having a pressure activated splittable feature |
US13/216,029 | 2011-08-23 | ||
PCT/US2012/049858 WO2013028348A1 (en) | 2011-08-23 | 2012-08-07 | A catheter having a pressure activated splittable feature |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ621749A NZ621749A (en) | 2015-09-25 |
NZ621749B2 true NZ621749B2 (en) | 2016-01-06 |
Family
ID=
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