US20230181877A1 - Needle cover retention - Google Patents
Needle cover retention Download PDFInfo
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- US20230181877A1 US20230181877A1 US18/107,252 US202318107252A US2023181877A1 US 20230181877 A1 US20230181877 A1 US 20230181877A1 US 202318107252 A US202318107252 A US 202318107252A US 2023181877 A1 US2023181877 A1 US 2023181877A1
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- United States
- Prior art keywords
- strain relief
- catheter
- nose
- catheter assembly
- needle
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
-
- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
-
- 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
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
-
- 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
- A61M25/065—Guide needles
-
- 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
- A61M2025/0058—Catheters; Hollow probes characterised by structural features having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing
-
- 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
- A61M2025/0098—Catheters; Hollow probes having a strain relief at the proximal end, e.g. sleeve
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
Definitions
- Catheters are commonly used for a variety of infusion therapies.
- catheters may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient.
- catheters may also be used for withdrawing blood from the patient.
- a common type of catheter is an over-the-needle peripheral intravenous catheter (“PIVC”).
- PIVC peripheral intravenous catheter
- the over-the-needle PIVC may be mounted over an introducer needle having a sharp distal tip.
- the PIVC and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing up away from skin of the patient.
- the PIVC and the introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.
- a clinician In order to verify proper placement of the introducer needle and/or the PIVC in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of a PIVC assembly. Once placement of the needle has been confirmed, the clinician may temporarily occlude flow in the vasculature and remove the introducer needle, leaving the PIVC in place for future blood withdrawal and/or fluid infusion.
- the PIVC assembly may be coupled with an extension set, which may allow coupling of an infusion or blood withdrawal device at a location removed from an insertion site of the PIVC.
- the present disclosure presents systems and methods to significantly limit and/or prevent needle sticks.
- the subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced.
- a catheter assembly may include a catheter adapter, which may include a body and a nose extending distally from the body.
- the nose may be generally cylindrical.
- a strain relief rib may be disposed on the nose.
- the strain relief rib may be constructed of a compliant or flexible material.
- the catheter assembly may include a catheter, which may be secured within the catheter adapter and may extend distally beyond the nose.
- the catheter assembly may include a needle, which may be disposed within the catheter and may extend distal to a distal end of the catheter.
- the catheter assembly may include a needle cover, which may be removably coupled to the nose of the catheter adapter.
- the needle cover may be removably coupled to the distal end of the catheter adapter via a friction fit.
- an inner surface of the needle cover may be smooth and may contact the strain relief rib.
- the needle cover may be generally cylindrical and may include an open proximal end or a closed proximal end.
- the flexible material may include an elastomer. In some embodiments, the flexible material may include a thermoplastic elastomer. In some embodiments, the nose may be constructed of a rigid or semi-rigid material. In some embodiments, the strain relief rib may be generally aligned with a longitudinal axis of the catheter adapter. In some embodiments, the strain relief rib may be disposed on a bottom of the catheter adapter.
- a strain relief element may be disposed on a distal end of the nose.
- the strain relief element may at least partially surround the needle and/or the catheter.
- the strain relief element may be constructed of the flexible material or another flexible material.
- the catheter adapter may include a stop configured to prevent proximal movement of the needle cover beyond the stop.
- the stop may be proximate and proximal to the nose.
- the strain relief rib may extend from the strain relief element to the stop.
- multiple strain relief ribs may be disposed on the nose.
- the strain relief rib may be a first strain relief rib.
- a second strain relief rib may be disposed on the nose and/or a third strain relief rib disposed on the nose.
- the second strain relief rib and the third strain relief rib may be constructed of the flexible material or another flexible material.
- the inner surface of the needle cover may contact the second strain relief rib and the third strain relief rib.
- the second strain relief rib and/or the third strain relief rib may be aligned with a longitudinal axis of the catheter adapter. In some embodiments, the second strain relief rib and/or the third strain relief rib may be disposed on an opposite side of the nose as the first strain relief rib. In some embodiments, the second strain relief rib and/or the third strain relief rib may be disposed on a top of the nose. In some embodiments, the second strain relief rib and/or the third strain relief rib extend from the strain relief element to the stop. In some embodiments, the first strain relief rib may be larger than the second strain relief rib and/or the third strain relief rib.
- a height of the first strain relief rib may be greater than a height of the second strain relief rib and/or the third strain relief rib. Additionally or alternatively, in some embodiments, a width of the first strain relief rib may be greater than a width of the second strain relief rib and/or the third strain relief rib.
- FIG. 1 A is a finite element analysis of a cross-section of a prior art needle cover
- FIG. 1 B is a longitudinal cross-sectional view of the prior art needle cover of FIG. 1 A ;
- FIG. 2 A is an upper perspective view of an example catheter assembly, illustrating an example needle cover shielding an example needle, according to some embodiments;
- FIG. 2 B is an upper perspective view of the needle cover of FIG. 2 A , according to some embodiments;
- FIG. 2 C is a cross-sectional view of the needle cover of FIG. 2 A , according to some embodiments;
- FIG. 3 A is an upper perspective view of an example distal end of the catheter assembly of FIG. 2 A , illustrating the needle cover removed, according to some embodiments;
- FIG. 3 B is a cross-sectional view of the catheter assembly of FIG. 2 A along the line 3 B- 3 B of FIG. 3 A , according to some embodiments;
- FIG. 3 C is a cross-sectional view of the catheter assembly of FIG. 2 A along the line 3 C- 3 C of FIG. 2 A , according to some embodiments;
- FIG. 3 D is an example finite element analysis of a portion of the cross-sectional view of FIG. 3 C , according to some embodiments;
- FIG. 4 A is an upper perspective view of another example catheter assembly, according to some embodiments.
- FIG. 4 B is an upper perspective view of an example distal end of the catheter assembly of FIG. 4 A , according to some embodiments;
- FIG. 4 C is a cross-sectional view of the catheter assembly of FIG. 4 B along the line 4 C- 4 C of FIG. 4 B , according to some embodiments;
- FIG. 4 D is a cross-sectional view of the catheter assembly of FIG. 4 A along the line 4 D- 4 D of FIG. 4 A , according to some embodiments.
- FIG. 4 E is an example finite element analysis of a portion of the cross-sectional view of FIG. 4 D , according to some embodiments.
- FIG. 1 A a finite element analysis of a cross-section of a prior art needle cover 10 is illustrated.
- the prior art needle cover 10 has three internal lobes 12 that protrude from an inner surface 14 of the prior art needle cover 10 .
- the prior art needle cover 10 and a catheter adapter 16 are coupled together in a press fit in which the internal lobes 12 contact and press upon an outer surface of a catheter adapter 16 .
- the internal lobes 12 may extend along a portion of the inner surface 14 of the prior art needle cover 10 .
- the catheter assembly 20 may include a catheter adapter 22 , which may include a body 24 and a nose 26 extending distally from the body 24 .
- the nose 26 may be generally cylindrical.
- the catheter assembly 20 may include a catheter 28 , which may include a PIVC.
- a proximal end of the catheter 28 may be secured within the catheter adapter 22 .
- the catheter 28 may extend distally beyond the nose 26 .
- the catheter assembly 20 may include a needle assembly 30 , which may be removably coupled to a proximal end of the catheter adapter 22 .
- the needle assembly 30 may include an introducer needle 32 .
- the introducer needle 32 may extend through the catheter 28 .
- flashback of blood may flow through a sharp distal tip 34 of the introducer needle 32 and may be visible to a clinician between the introducer needle 32 and the catheter 28 and/or at another location within the catheter assembly 20 .
- the needle assembly 30 in response to confirmation via the blood flashback that the catheter 28 is positioned within the vasculature of the patient, the needle assembly 30 may be removed from the catheter assembly 20 . In some embodiments, when the needle assembly 30 is coupled to the catheter assembly 20 , the introducer needle 32 of the needle assembly 30 may extend through a septum disposed within the lumen of the catheter adapter 22 .
- the catheter assembly 20 may include a needle cover 36 .
- the needle cover 36 may be removably coupled to the distal end of the catheter adapter 22 via a friction fit.
- the needle cover 36 may be removably coupled to the nose 26 of the catheter adapter 22 via a friction fit.
- the needle cover 36 may be removed prior to insertion of the catheter 28 into the vasculature of the patient to expose the distal tip 34 of the introducer needle 32 .
- the needle cover 36 may be generally cylindrical.
- the needle cover 36 may include a distal end 38 , which may be closed as illustrated in FIG. 2 C .
- the distal end 38 of the needle cover 36 may be open.
- an inner surface 40 of the needle cover 36 may be smooth, which may prevent the clinician or manufacturer from orienting the needle cover 36 to secure the needle cover 36 over the introducer needle 32 .
- a strain relief rib 42 may be disposed on the nose 26 .
- the strain relief rib 42 may be constructed of a compliant or flexible material, which may be illustrated with a dot pattern in the present disclosure.
- the inner surface 40 of the needle cover 36 may be smooth and may contact the strain relief rib 42 .
- the strain relief rib 42 may allow a size of the needle cover 36 to be reduced, compared to the prior art needle cover 10 , and also may allow the nose 26 to be small, while facilitating securement of the needle cover 36 to the catheter adapter 22 .
- the flexible material may include an elastomer. In some embodiments, the flexible material may include a thermoplastic elastomer.
- the nose 26 may be constructed of a rigid or semi-rigid material.
- the nose 26 may include copolyester, plastic, or another suitable material.
- the flexible material may have a higher coefficient of friction with respect to a material of the needle cover 36 than the rigid or semi-rigid material.
- the needle cover 36 may be constructed of the rigid or semi-rigid material or another suitable material.
- the strain relief rib 42 may be generally aligned with a longitudinal axis 44 (illustrated, for example, in FIG. 2 A ) of the catheter adapter 22 . In some embodiments, the strain relief rib 42 may be disposed on a bottom of the catheter adapter 22 , as illustrated, for example, in FIG. 3 A . In some embodiments, the strain relief rib 42 may relieve bending strain on the catheter 28 when the catheter 28 is inserted into the vasculature of the patient. In some embodiments, a bevel of the introducer needle 32 may point upward or away from the bottom of the catheter adapter 22 , as illustrated, for example, in FIG. 3 A .
- the catheter adapter 16 may include any suitable catheter adapter.
- the catheter adapter 16 may include a securement platform 46 , which may include a first wing 48 and/or a second wing 50 .
- the first wing 48 may overlie a grip 52 , which may extend from the needle assembly 30 .
- the grip 52 and/or the second wing 50 may contact and rest upon the skin of the patient when the catheter 28 is inserted into skin of the patient.
- the bottom of the catheter adapter 22 may be configured to face the skin of the patient when the catheter 28 is inserted into skin of the patient.
- the catheter adapter 16 may not include the securement platform 46 and/or the grip 52 .
- the catheter adapter 16 may be integrated, having an integrated extension tube 54 , as illustrated, for example, in FIG. 2 A . In other embodiments, the catheter adapter 16 may not include the integrated extension tube 54 .
- a distal end of the nose 26 may include a strain relief element 56 , which may at least partially surround the introducer needle 32 and/or the catheter 28 .
- the strain relief element 56 may be constructed of the flexible material or another flexible material.
- the catheter adapter 22 may include a stop 58 configured to prevent proximal movement of the needle cover 36 beyond the stop 58 .
- the stop 58 may include a flange or stepped surface.
- the stop 58 may be angled or perpendicular to the longitudinal axis 44 .
- the stop 58 may be proximate and proximal to the nose 26 .
- the strain relief rib 42 may extend from the strain relief element 56 to the stop 58 .
- the needle cover 36 may be removably coupled to the distal end of the catheter adapter 22 via a friction fit.
- the needle cover 36 may be removably coupled to the nose 26 of the catheter adapter 22 via a friction fit.
- friction between the strain relief rib 42 and the needle cover 36 may retain the needle cover 36 over the distal tip 34 of the introducer needle 32 .
- the strain relief rib 42 may be compressed when the needle cover 36 is removably coupled to the nose 26 via a friction fit.
- FIG. 3 D illustrates that the needle cover 36 may experience a flexing beam effect as opposed to an annular hoop stress, which may occur if the catheter assembly 20 included a flexible ring extending around an outer circumference of the nose 26 .
- the flexing beam effect may occur at areas of the inner surface 40 of the needle cover 36 that do not contact the strain relief rib 42 or the nose 26 , as illustrated, for example in FIG. 3 D .
- a disadvantage to an annular press fit of two cylindrical bodies, such as the needle cover 36 and the flexible ring, is that with typical molding tolerances, a difference between a least material condition interference and a maximum material condition interference may be as high as ten times.
- the catheter assembly 60 may include or correspond to the catheter assembly 20 .
- the catheter assembly 60 may include one or more features of the catheter assembly 20 and/or the catheter assembly 10 may include one or more features of the catheter assembly 60 .
- one or more other strain relief ribs 62 may be disposed on the nose 26 .
- the other strain relief ribs 62 may include one or more features of the strain relief rib 42 .
- the other strain relief ribs 62 may be constructed of the flexible material or another flexible material.
- the inner surface 40 of the needle cover 36 may contact and compress the other strain relief ribs 62 to secure the needle cover 36 over the distal tip 34 of the introducer needle 32 in a friction fit.
- the other strain relief ribs 62 may be aligned with the longitudinal axis 44 of the catheter adapter 22 . In some embodiments, one or more of the other strain relief ribs 62 may be disposed on an opposite side of the nose 26 as the strain relief rib 42 . In some embodiments, one or more of the other strain relief ribs 62 may be disposed on a top of the nose 26 , as illustrated, for example, in FIG. 4 B .
- the nose 26 and the strain relief rib 42 and/or the other strain relief ribs 62 may be constructed in at least a two shot mold.
- a first hard shot may form the nose 26 in a rigid or semi-rigid material
- a second soft shot may form the strain relief rib 42 and/or the other strain relief ribs 62 in the flexible material.
- one or more of the other strain relief ribs 62 may extend from the strain relief element 56 to the stop 58 .
- the strain relief rib 42 may be larger than the other strain relief ribs 62 .
- a height 64 of the strain relief rib 42 may be greater than a height 66 of the other strain relief ribs 62 .
- a width 68 of the strain relief rib 42 may be greater than a width 70 of the strain relief ribs 62 .
- the height 64 and the height 66 may be measured from the nose 26 to an outer most edge of the strain relief rib 62 and the other strain relief ribs 62 , respectively, perpendicular to the longitudinal axis 44 .
- the other strain relief ribs 62 and the strain relief rib 42 may be approximately a same size.
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Abstract
A catheter assembly may include a catheter adapter, which may include a body and a nose extending distally from the body. The nose may be generally cylindrical. A strain relief rib may be disposed on the nose. The strain relief rib may be constructed of a flexible material. The catheter assembly may also include a needle secured within the catheter adapter and extending distally beyond the nose. The catheter assembly may further include a needle cover, which may be removably coupled to the nose of the catheter adapter. An inner surface of the needle cover may be smooth and may contact the strain relief rib.
Description
- This application is a divisional of U.S. patent application Ser. No. 16/694,774, filed Nov. 25, 2019, and entitled NEEDLE COVER RETENTION, which claims the benefit of U.S. Provisional Application No. 62/772,482, filed Nov. 28, 2018, and entitled NEEDLE COVER RETENTION, which are incorporated herein in their entirety.
- Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient. Catheters may also be used for withdrawing blood from the patient.
- A common type of catheter is an over-the-needle peripheral intravenous catheter (“PIVC”). As its name implies, the over-the-needle PIVC may be mounted over an introducer needle having a sharp distal tip. The PIVC and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing up away from skin of the patient. The PIVC and the introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.
- In order to verify proper placement of the introducer needle and/or the PIVC in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of a PIVC assembly. Once placement of the needle has been confirmed, the clinician may temporarily occlude flow in the vasculature and remove the introducer needle, leaving the PIVC in place for future blood withdrawal and/or fluid infusion. The PIVC assembly may be coupled with an extension set, which may allow coupling of an infusion or blood withdrawal device at a location removed from an insertion site of the PIVC.
- There is a risk of accidental needle sticks if the distal tip of the introducer needle is not secured properly in a needle cover or shield. The present disclosure presents systems and methods to significantly limit and/or prevent needle sticks. The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced.
- The present disclosure relates generally to vascular access devices and related systems and methods. In some embodiments, a catheter assembly may include a catheter adapter, which may include a body and a nose extending distally from the body. In some embodiments, the nose may be generally cylindrical. In some embodiments, a strain relief rib may be disposed on the nose. In some embodiments, the strain relief rib may be constructed of a compliant or flexible material.
- In some embodiments, the catheter assembly may include a catheter, which may be secured within the catheter adapter and may extend distally beyond the nose. In some embodiments, the catheter assembly may include a needle, which may be disposed within the catheter and may extend distal to a distal end of the catheter. In some embodiments, the catheter assembly may include a needle cover, which may be removably coupled to the nose of the catheter adapter. In some embodiments, the needle cover may be removably coupled to the distal end of the catheter adapter via a friction fit. In some embodiments, an inner surface of the needle cover may be smooth and may contact the strain relief rib. In some embodiments, the needle cover may be generally cylindrical and may include an open proximal end or a closed proximal end.
- In some embodiments, the flexible material may include an elastomer. In some embodiments, the flexible material may include a thermoplastic elastomer. In some embodiments, the nose may be constructed of a rigid or semi-rigid material. In some embodiments, the strain relief rib may be generally aligned with a longitudinal axis of the catheter adapter. In some embodiments, the strain relief rib may be disposed on a bottom of the catheter adapter.
- In some embodiments, a strain relief element may be disposed on a distal end of the nose. In some embodiments, the strain relief element may at least partially surround the needle and/or the catheter. In some embodiments, the strain relief element may be constructed of the flexible material or another flexible material. In some embodiments, the catheter adapter may include a stop configured to prevent proximal movement of the needle cover beyond the stop. In some embodiments, the stop may be proximate and proximal to the nose. In some embodiments, the strain relief rib may extend from the strain relief element to the stop.
- In some embodiments, multiple strain relief ribs may be disposed on the nose. In some embodiments, the strain relief rib may be a first strain relief rib. In some embodiments, a second strain relief rib may be disposed on the nose and/or a third strain relief rib disposed on the nose. In some embodiments, the second strain relief rib and the third strain relief rib may be constructed of the flexible material or another flexible material. In some embodiments, the inner surface of the needle cover may contact the second strain relief rib and the third strain relief rib.
- In some embodiments, the second strain relief rib and/or the third strain relief rib may be aligned with a longitudinal axis of the catheter adapter. In some embodiments, the second strain relief rib and/or the third strain relief rib may be disposed on an opposite side of the nose as the first strain relief rib. In some embodiments, the second strain relief rib and/or the third strain relief rib may be disposed on a top of the nose. In some embodiments, the second strain relief rib and/or the third strain relief rib extend from the strain relief element to the stop. In some embodiments, the first strain relief rib may be larger than the second strain relief rib and/or the third strain relief rib. In further detail, in some embodiments, a height of the first strain relief rib may be greater than a height of the second strain relief rib and/or the third strain relief rib. Additionally or alternatively, in some embodiments, a width of the first strain relief rib may be greater than a width of the second strain relief rib and/or the third strain relief rib.
- It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.
- Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
-
FIG. 1A is a finite element analysis of a cross-section of a prior art needle cover; -
FIG. 1B is a longitudinal cross-sectional view of the prior art needle cover ofFIG. 1A ; -
FIG. 2A is an upper perspective view of an example catheter assembly, illustrating an example needle cover shielding an example needle, according to some embodiments; -
FIG. 2B is an upper perspective view of the needle cover ofFIG. 2A , according to some embodiments; -
FIG. 2C is a cross-sectional view of the needle cover ofFIG. 2A , according to some embodiments; -
FIG. 3A is an upper perspective view of an example distal end of the catheter assembly ofFIG. 2A , illustrating the needle cover removed, according to some embodiments; -
FIG. 3B is a cross-sectional view of the catheter assembly ofFIG. 2A along the line 3B-3B ofFIG. 3A , according to some embodiments; -
FIG. 3C is a cross-sectional view of the catheter assembly ofFIG. 2A along the line 3C-3C ofFIG. 2A , according to some embodiments; -
FIG. 3D is an example finite element analysis of a portion of the cross-sectional view ofFIG. 3C , according to some embodiments; -
FIG. 4A is an upper perspective view of another example catheter assembly, according to some embodiments; -
FIG. 4B is an upper perspective view of an example distal end of the catheter assembly ofFIG. 4A , according to some embodiments; -
FIG. 4C is a cross-sectional view of the catheter assembly ofFIG. 4B along the line 4C-4C ofFIG. 4B , according to some embodiments; -
FIG. 4D is a cross-sectional view of the catheter assembly ofFIG. 4A along the line 4D-4D ofFIG. 4A , according to some embodiments; and -
FIG. 4E is an example finite element analysis of a portion of the cross-sectional view ofFIG. 4D , according to some embodiments. - Referring now to
FIG. 1A , a finite element analysis of a cross-section of a priorart needle cover 10 is illustrated. The priorart needle cover 10 has threeinternal lobes 12 that protrude from aninner surface 14 of the priorart needle cover 10. The priorart needle cover 10 and acatheter adapter 16 are coupled together in a press fit in which theinternal lobes 12 contact and press upon an outer surface of acatheter adapter 16. Referring now toFIG. 1B , theinternal lobes 12 may extend along a portion of theinner surface 14 of the priorart needle cover 10. - Referring now to
FIG. 2A , anexample catheter assembly 20 is illustrated, according to some embodiments. In some embodiments, thecatheter assembly 20 may include acatheter adapter 22, which may include abody 24 and anose 26 extending distally from thebody 24. In some embodiments, thenose 26 may be generally cylindrical. - In some embodiments, the
catheter assembly 20 may include acatheter 28, which may include a PIVC. In some embodiments, a proximal end of thecatheter 28 may be secured within thecatheter adapter 22. In some embodiments, thecatheter 28 may extend distally beyond thenose 26. - In some embodiments, the
catheter assembly 20 may include aneedle assembly 30, which may be removably coupled to a proximal end of thecatheter adapter 22. In some embodiments, theneedle assembly 30 may include anintroducer needle 32. In some embodiments, theintroducer needle 32 may extend through thecatheter 28. - In some embodiments, in response to the
introducer needle 32 being inserted into a vasculature of a patient, flashback of blood may flow through a sharpdistal tip 34 of theintroducer needle 32 and may be visible to a clinician between theintroducer needle 32 and thecatheter 28 and/or at another location within thecatheter assembly 20. - In some embodiments, in response to confirmation via the blood flashback that the
catheter 28 is positioned within the vasculature of the patient, theneedle assembly 30 may be removed from thecatheter assembly 20. In some embodiments, when theneedle assembly 30 is coupled to thecatheter assembly 20, theintroducer needle 32 of theneedle assembly 30 may extend through a septum disposed within the lumen of thecatheter adapter 22. - In some embodiments, the
catheter assembly 20 may include aneedle cover 36. In some embodiments, theneedle cover 36 may be removably coupled to the distal end of thecatheter adapter 22 via a friction fit. In some embodiments, theneedle cover 36 may be removably coupled to thenose 26 of thecatheter adapter 22 via a friction fit. In some embodiments, theneedle cover 36 may be removed prior to insertion of thecatheter 28 into the vasculature of the patient to expose thedistal tip 34 of theintroducer needle 32. - Referring now to
FIGS. 2B-2C , in some embodiments, theneedle cover 36 may be generally cylindrical. In some embodiments, theneedle cover 36 may include adistal end 38, which may be closed as illustrated inFIG. 2C . In some embodiments, thedistal end 38 of theneedle cover 36 may be open. In some embodiments, aninner surface 40 of theneedle cover 36 may be smooth, which may prevent the clinician or manufacturer from orienting theneedle cover 36 to secure theneedle cover 36 over theintroducer needle 32. - Referring now to
FIG. 3A-3B , in some embodiments, astrain relief rib 42 may be disposed on thenose 26. In some embodiments, thestrain relief rib 42 may be constructed of a compliant or flexible material, which may be illustrated with a dot pattern in the present disclosure. In some embodiments, theinner surface 40 of theneedle cover 36 may be smooth and may contact thestrain relief rib 42. In some embodiments, thestrain relief rib 42 may allow a size of theneedle cover 36 to be reduced, compared to the priorart needle cover 10, and also may allow thenose 26 to be small, while facilitating securement of theneedle cover 36 to thecatheter adapter 22. - In some embodiments, the flexible material may include an elastomer. In some embodiments, the flexible material may include a thermoplastic elastomer. In some embodiments, the
nose 26 may be constructed of a rigid or semi-rigid material. For example, thenose 26 may include copolyester, plastic, or another suitable material. In some embodiments, the flexible material may have a higher coefficient of friction with respect to a material of theneedle cover 36 than the rigid or semi-rigid material. In some embodiments, theneedle cover 36 may be constructed of the rigid or semi-rigid material or another suitable material. - In some embodiments, the
strain relief rib 42 may be generally aligned with a longitudinal axis 44 (illustrated, for example, inFIG. 2A ) of thecatheter adapter 22. In some embodiments, thestrain relief rib 42 may be disposed on a bottom of thecatheter adapter 22, as illustrated, for example, inFIG. 3A . In some embodiments, thestrain relief rib 42 may relieve bending strain on thecatheter 28 when thecatheter 28 is inserted into the vasculature of the patient. In some embodiments, a bevel of theintroducer needle 32 may point upward or away from the bottom of thecatheter adapter 22, as illustrated, for example, inFIG. 3A . - In some embodiments, the
catheter adapter 16 may include any suitable catheter adapter. In some embodiments, thecatheter adapter 16 may include asecurement platform 46, which may include afirst wing 48 and/or asecond wing 50. In some embodiments, thefirst wing 48 may overlie agrip 52, which may extend from theneedle assembly 30. In some embodiments, thegrip 52 and/or thesecond wing 50 may contact and rest upon the skin of the patient when thecatheter 28 is inserted into skin of the patient. The bottom of thecatheter adapter 22 may be configured to face the skin of the patient when thecatheter 28 is inserted into skin of the patient. In some embodiments, thecatheter adapter 16 may not include thesecurement platform 46 and/or thegrip 52. In some embodiments, thecatheter adapter 16 may be integrated, having anintegrated extension tube 54, as illustrated, for example, inFIG. 2A . In other embodiments, thecatheter adapter 16 may not include theintegrated extension tube 54. - In some embodiments, a distal end of the
nose 26 may include astrain relief element 56, which may at least partially surround theintroducer needle 32 and/or thecatheter 28. In some embodiments, thestrain relief element 56 may be constructed of the flexible material or another flexible material. In some embodiments, thecatheter adapter 22 may include astop 58 configured to prevent proximal movement of theneedle cover 36 beyond thestop 58. In some embodiments, thestop 58 may include a flange or stepped surface. In some embodiments, thestop 58 may be angled or perpendicular to thelongitudinal axis 44. In some embodiments, thestop 58 may be proximate and proximal to thenose 26. In some embodiments, thestrain relief rib 42 may extend from thestrain relief element 56 to thestop 58. - Referring now to
FIG. 3C-3D , in some embodiments, theneedle cover 36 may be removably coupled to the distal end of thecatheter adapter 22 via a friction fit. In some embodiments, theneedle cover 36 may be removably coupled to thenose 26 of thecatheter adapter 22 via a friction fit. In these embodiments, friction between thestrain relief rib 42 and theneedle cover 36 may retain theneedle cover 36 over thedistal tip 34 of theintroducer needle 32. In some embodiments, thestrain relief rib 42 may be compressed when theneedle cover 36 is removably coupled to thenose 26 via a friction fit. -
FIG. 3D illustrates that theneedle cover 36 may experience a flexing beam effect as opposed to an annular hoop stress, which may occur if thecatheter assembly 20 included a flexible ring extending around an outer circumference of thenose 26. The flexing beam effect may occur at areas of theinner surface 40 of theneedle cover 36 that do not contact thestrain relief rib 42 or thenose 26, as illustrated, for example inFIG. 3D . A disadvantage to an annular press fit of two cylindrical bodies, such as theneedle cover 36 and the flexible ring, is that with typical molding tolerances, a difference between a least material condition interference and a maximum material condition interference may be as high as ten times. - Referring now to
FIG. 4A , another catheter assembly 60 is illustrated, according to some embodiments. In some embodiments, the catheter assembly 60 may include or correspond to thecatheter assembly 20. In some embodiments, the catheter assembly 60 may include one or more features of thecatheter assembly 20 and/or thecatheter assembly 10 may include one or more features of the catheter assembly 60. - In some embodiments, in addition or as an alternative to the
strain relief rib 42, one or more otherstrain relief ribs 62 may be disposed on thenose 26. In some embodiments, the otherstrain relief ribs 62 may include one or more features of thestrain relief rib 42. In some embodiments, the otherstrain relief ribs 62 may be constructed of the flexible material or another flexible material. In some embodiments, theinner surface 40 of theneedle cover 36 may contact and compress the otherstrain relief ribs 62 to secure theneedle cover 36 over thedistal tip 34 of theintroducer needle 32 in a friction fit. - In some embodiments, the other
strain relief ribs 62 may be aligned with thelongitudinal axis 44 of thecatheter adapter 22. In some embodiments, one or more of the otherstrain relief ribs 62 may be disposed on an opposite side of thenose 26 as thestrain relief rib 42. In some embodiments, one or more of the otherstrain relief ribs 62 may be disposed on a top of thenose 26, as illustrated, for example, inFIG. 4B . - In some embodiments, the
nose 26 and thestrain relief rib 42 and/or the otherstrain relief ribs 62 may be constructed in at least a two shot mold. In some embodiments, a first hard shot may form thenose 26 in a rigid or semi-rigid material, and a second soft shot may form thestrain relief rib 42 and/or the otherstrain relief ribs 62 in the flexible material. - In some embodiments, one or more of the other
strain relief ribs 62 may extend from thestrain relief element 56 to thestop 58. In some embodiments, thestrain relief rib 42 may be larger than the otherstrain relief ribs 62. In further detail, in some embodiments, aheight 64 of thestrain relief rib 42 may be greater than aheight 66 of the otherstrain relief ribs 62. Additionally or alternatively, in some embodiments, a width 68 of thestrain relief rib 42 may be greater than awidth 70 of thestrain relief ribs 62. Theheight 64 and theheight 66 may be measured from thenose 26 to an outer most edge of thestrain relief rib 62 and the otherstrain relief ribs 62, respectively, perpendicular to thelongitudinal axis 44. In some embodiments, the otherstrain relief ribs 62 and thestrain relief rib 42 may be approximately a same size. - All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.
Claims (20)
1. A catheter assembly, comprising:
a catheter adapter comprising a nose, wherein a distal end of the nose comprises a strain relief element constructed of a flexible material, wherein a proximal end of the strain relief element comprises an outer circumference;
a strain relief rib extending proximally from the outer circumference of the strain relief element and having a longitudinal axis aligned with a longitudinal axis of the catheter adapter, wherein the strain relief rib is constructed of the flexible material or another flexible material;
a catheter secured within the catheter adapter and extending distally beyond the distal end of the catheter adapter;
a needle extending through the catheter and distally beyond the distal end of the catheter adapter, wherein the strain relief element surrounds the needle and the catheter; and
a needle cover removably coupled to the catheter adapter, wherein an inner surface of the needle cover is in contact with the strain relief rib.
2. The catheter assembly of claim 1 , wherein the flexible material comprises an elastomer.
3. The catheter assembly of claim 1 , wherein the flexible material comprises a thermoplastic elastomer.
4. The catheter assembly of claim 1 , wherein the nose is constructed of a rigid or semi-rigid material.
5. The catheter assembly of claim 1 , wherein the strain relief element is disposed on a distalmost surface of the nose.
6. The catheter assembly of claim 1 , wherein the catheter adapter includes a securement platform.
7. The catheter assembly of claim 6 , wherein the securement platform comprises a first wing and a second wing.
8. A catheter assembly, comprising:
a catheter adapter comprising a body and a nose extending distally from the body, wherein the nose is generally cylindrical, wherein a distal end of the nose comprises a strain relief element constructed of a flexible material;
a needle secured within the catheter adapter and extending distally beyond the nose; and
a needle cover configured to be removably coupled to the nose of the catheter adapter, wherein an inner surface of the needle cover comprises three internal lobes contacting the strain relief element.
9. The catheter assembly of claim 8 , wherein the three internal lobes are evenly spaced around the inner surface of the needle cover.
10. The catheter assembly of claim 8 , wherein the flexible material comprises an elastomer.
11. The catheter assembly of claim 8 , wherein the flexible material comprises a thermoplastic elastomer.
12. The catheter assembly of claim 8 , wherein the strain relief element surrounds the needle.
13. The catheter assembly of claim 8 , wherein the needle cover is removably coupled to the distal end of the catheter adapter via a friction fit.
14. The catheter assembly of claim 8 , wherein the needle cover is generally cylindrical having an open proximal end.
15. A catheter assembly, comprising:
a catheter adapter comprising a body and a nose extending distally from the body, wherein the nose is generally cylindrical;
a strain relief rib disposed on a bottom of the nose, wherein the strain relief rib is constructed of a flexible material;
a needle secured within the catheter adapter and extending distally beyond the nose, wherein the needle comprises a bevel pointing upward opposite the bottom; and
a needle cover configured to be removably coupled to the nose of the catheter adapter, wherein an inner surface of the needle cover is smooth and is configured to contact the strain relief rib.
16. The catheter assembly of claim 15 , wherein a distal end of the nose comprises a strain relief element constructed of the flexible material or another flexible material, wherein a proximal end of the strain relief element comprises an outer circumference, wherein the strain relief rib extends proximally from the outer circumference of the strain relief element and has a longitudinal axis aligned with a longitudinal axis of the catheter adapter
17. The catheter assembly of claim 15 , wherein the flexible material comprises an elastomer.
18. The catheter assembly of claim 15 , wherein the flexible material comprises a thermoplastic elastomer.
19. The catheter assembly of claim 15 , wherein the strain relief rib is generally aligned with a longitudinal axis of the catheter adapter.
20. The catheter assembly of claim 15 , wherein the catheter adapter further comprises a stop configured to prevent proximal movement of the needle cover beyond the stop, wherein the stop is disposed proximate and proximal to the nose, wherein the strain relief rib extends to the stop.
Priority Applications (1)
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US18/107,252 US20230181877A1 (en) | 2018-11-28 | 2023-02-08 | Needle cover retention |
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US201862772482P | 2018-11-28 | 2018-11-28 | |
US16/694,774 US11612723B2 (en) | 2018-11-28 | 2019-11-25 | Needle cover retention |
US18/107,252 US20230181877A1 (en) | 2018-11-28 | 2023-02-08 | Needle cover retention |
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US20210379339A1 (en) * | 2020-06-09 | 2021-12-09 | Becton, Dickinson And Company | Needle cover retention |
USD977629S1 (en) * | 2020-12-01 | 2023-02-07 | Becton, Dickinson And Company | Catheter system having a pinch clamp |
Family Cites Families (12)
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DE1007477B (en) * | 1954-06-16 | 1957-05-02 | Willy Ruesch | Cardiac catheter and process for its manufacture |
GB1587153A (en) * | 1977-02-22 | 1981-04-01 | Taut Inc | Needle and hub assembly for a catheter assembly and a catheter placement assembly incorporating the same |
US7625365B2 (en) * | 2001-09-21 | 2009-12-01 | Boston Scientific Scimed, Inc. | Intravascular device and carrier tube with interference fit member |
BRPI0408886A (en) * | 2003-04-08 | 2006-04-11 | Medex Inc | catheter introducer sets |
US8012144B2 (en) * | 2003-09-22 | 2011-09-06 | Boston Scientific Scimed, Inc. | Elongate medical device having an interference fit packaging member |
US8257322B2 (en) * | 2010-06-02 | 2012-09-04 | Smiths Medical Asd, Inc. | Tip protector for a safety catheter |
WO2012162677A1 (en) * | 2011-05-25 | 2012-11-29 | Access Scientific, Inc. | Access device |
EP2726140B1 (en) * | 2011-07-01 | 2020-12-16 | Coloplast A/S | A catheter with a balloon |
WO2014120741A1 (en) * | 2013-01-30 | 2014-08-07 | Vascular Pathways, Inc. | Systems and methods for venipuncture and catheter placement |
MX2017014565A (en) * | 2015-05-15 | 2018-03-09 | Bard Inc C R | Catheter placement device including an extensible needle safety component. |
US10786650B2 (en) * | 2015-10-28 | 2020-09-29 | Becton, Dickinson And Company | Catheter adapter providing catheter kink resistance |
US11278705B2 (en) * | 2017-05-04 | 2022-03-22 | Becton, Dickinson And Company | Intravenous catheter systems and methods |
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2019
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- 2019-11-26 JP JP2021530249A patent/JP7418431B2/en active Active
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CN113164715B (en) | 2023-10-20 |
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CN113164715A (en) | 2021-07-23 |
SG11202104698SA (en) | 2021-06-29 |
BR112021009760A2 (en) | 2021-08-17 |
AU2019387215A1 (en) | 2021-07-08 |
CA3119592A1 (en) | 2020-06-04 |
EP3886967A1 (en) | 2021-10-06 |
KR20210095902A (en) | 2021-08-03 |
WO2020112892A1 (en) | 2020-06-04 |
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