Low tensile septum for a catheter system
The septum design in catheter assemblies addresses the challenges of vein placement and withdrawal force in PIVCs by reducing contact area and using lubricants to enhance comfort and placement success.
Patent Information
- Application Number
- JP2023210234
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-08-05
- Filing Date
- 2023-12-13
- Publication Date
- 2025-08-01
- Estimated Expiration
- 2039-08-06
AI Technical Summary
Existing peripheral intravenous catheters (PIVCs) face challenges in confirming vein placement due to difficult vein occlusion, leading to blood leakage and increased tensile force during introducer needle withdrawal, causing patient discomfort and potential catheter dislodgment.
The septum design in the catheter assembly reduces tensile force by minimizing the surface area of contact between the introducer needle and the septum, using slots, channels, or grooves to facilitate easy withdrawal and maintain a seal, often filled with lubricant to hide blood droplets and reduce friction.
The septum design enhances patient comfort and improves the success rate of initial vein placement by reducing the force required to withdraw the introducer needle, minimizing blood leakage, and securing the catheter in the vein.
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Abstract
Description
Background Art
[0001] Background Catheters are commonly used for various infusion therapies. For example, a catheter may be used to inject fluids such as normal saline, various drugs, and total parenteral nutrition agents into a patient. A catheter may also be used to draw blood from a patient.
[0002] A common type of catheter is a peripheral intravenous catheter over-the-needle (「PIVC」). As its name implies, a PIVC may be mounted on an introducer needle having a sharp distal tip. The PIVC and the introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing upward and away from the patient's skin. The PIVC and the introducer needle are generally inserted at a shallow angle through the skin into the patient's venous system.
Summary of the Invention
Problems to be Solved by the Invention
[0003] To confirm proper placement of the introducer needle and / or PIVC within a vein, a user generally checks for a 「flashback」 of blood within the flashback chamber of the PIVC assembly. Once the needle placement is confirmed, the user may temporarily occlude the flow within the vein while leaving the PIVC in place within the vein and remove the introducer needle. The user may also attach a device for fluid infusion and / or blood withdrawal to the PIVC assembly. This process is actually somewhat difficult because many PIVC placement sites do not allow for easy occlusion of the vein. Furthermore, even when such occlusion is achieved, it is incomplete and may result in blood leakage from the PIVC assembly housing the PIVC, exposing healthcare workers to risk.
[0004] Thus, techniques have been provided in PIVC assemblies that provide various seals or “septa” to prevent fluid outflow during and following removal of the introducer needle from the vein. The septum may be secured within the PIVC assembly via friction and / or adhesives between the septum and the wall of the catheter assembly.
[0005] In some embodiments, after the PIVC has been placed within the vein, the introducer needle may be withdrawn from the PIVC assembly through the septum. The septum may significantly increase the force that a user must exert on the introducer needle to withdraw it from the PIVC assembly. The force applied by the user may cause pain to the patient and / or dislodge the PIVC from the vein.
[0006] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in the environments described above. Rather, this background is provided only to illustrate one exemplary technical field in which some of the embodiments described herein may be practiced. **Means for Solving the Problems**
[0007] Summary The present disclosure generally relates to septa for catheter assemblies and related systems and methods. In some embodiments, the septum may reduce the tensile force of the introducer needle that is moved with respect to the septum. In some embodiments, reducing the tensile force may improve patient comfort and facilitate the success of the first puncture or placement of the catheter into the vein on the first attempt. In some embodiments, the tensile force may be reduced by decreasing the surface area of the septum that contacts the introducer needle.
[0008] In some embodiments, the septum of the catheter assembly may include a body having a distal end portion and a proximal end portion. In some embodiments, the distal end portion and the proximal end portion of the body may be sealed. In some embodiments, the septum may include a slot disposed within the outer surface of the body and oriented along the longitudinal axis of the body. In some embodiments, the slot may include a distal end spaced from the distal end portion of the body and a proximal end spaced from the proximal end portion of the body. In some embodiments, the introducer needle may extend through the slot. In some embodiments, the introducer needle may be spaced from the bottom of the slot.
[0009] In some embodiments, the catheter assembly may include a catheter adapter and a catheter. In some embodiments, the catheter assembly may include a PIVC catheter assembly having a PIVC. In some embodiments, the catheter assembly may include an integrated catheter system having an integrated extension tube. In these and other embodiments, the septum may be disposed within the catheter adapter and may be configured for single use. In further detail, in some embodiments, when the catheter assembly is in the insertion position, the septum may be penetrated by the introducer needle, but after the catheter is positioned and the introducer needle is withdrawn through the septum, the septum may remain closed.
[0010] In some embodiments, the inner surface of the catheter adapter may seal the slot. In some embodiments, the catheter assembly may include a septum housing. In some embodiments, the septum may be at least partially disposed within the septum housing. In some embodiments, the inner surface of the septum housing may seal the slot.
[0011] In some embodiments, the length of the slot may correspond to more than half of the length of the body. In some embodiments, the depth of the slot may be greater than half the width of the body. In some embodiments, the bevel of the introduction needle may face upward, and the slot may face downward. In some embodiments, the slot may face downward such that droplets of blood disposed within the slot and from the introduction needle are hidden from the patient. In some embodiments, the slot may be filled with a lubricant, which may reduce the appearance of droplets of blood to the patient and reduce the tensile force.
[0012] In some embodiments, the septum may include a semi-circular groove disposed within the body. In some embodiments, the semi-circular groove may facilitate securing of the septum within the catheter adapter. In some embodiments, the semi-circular groove may extend around a portion of the perimeter of the body. In some embodiments, the slot may extend between a first end of the semi-circular groove and a second end of the semi-circular groove.
[0013] In some embodiments, the septum may include a channel, which may be disposed within the septum and oriented along the longitudinal axis of the body. In these and other embodiments, the septum may be formed monolithically as a single unit. In some embodiments, the channel may be formed by the inner surface of the body. In some embodiments, the introduction needle may extend through the channel. In some embodiments, the introduction needle may be spaced apart from the inner surface of the body. In some embodiments, at least a portion of the channel may be generally cylindrical. In some embodiments, the length of the channel may correspond to more than half of the length of the body.
[0014] In some embodiments, the septum may include a slit extending from the outer surface of the body to the channel. In some embodiments, the slit may be oriented along the longitudinal axis of the body. In some embodiments, the slit may be closed when the septum is disposed within the lumen of the catheter adapter. In some embodiments, the slit may extend over the entire length of the body. In some embodiments, the slit may extend partially over the length of the body.
[0015] In some embodiments, the septum may include a semi-circular groove or an annular groove, which may facilitate securing of the septum within the catheter adapter. In some embodiments, the slit may extend through the semi-circular groove or the annular groove. In some embodiments, the septum may be formed by injection molding. In some embodiments, the septum may be an elastomer. In some embodiments, the septum may be molded into a bulged position with the slit open to enable insertion of the mold and formation of the channel.
[0016] It will 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 devices shown in the drawings. Also, various embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Accordingly, the following detailed description should not be taken in a limiting sense.
Brief Description of the Drawings
[0017] Exemplary embodiments are described in further particularity and detail with reference to the accompanying drawings.
[0018]
Figure 1A
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Figure 1C
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Figure 2E
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Figure 3C
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Figure 5F
[0019] Description of Embodiments Referring now to FIGS. 1A - 1C, a prior art catheter assembly 10 is illustrated. The catheter assembly 10 may include a septum 12 disposed within the lumen of a catheter adapter 14 of the catheter assembly 10. A catheter 16 may extend distally from the catheter adapter 14. The septum 12 may correspond, for example, to the septum of a BD INTIMA II (trademark) IV catheter. After the user has confirmed that the catheter 16 of the catheter assembly 10 is disposed within a patient's vein, the introducer needle 18 of the catheter assembly 10 may be withdrawn from the patient and the catheter assembly 10, leaving only the catheter 16 in place within the vein. As shown in FIG. 1C, the entire portion of the introducer needle 18 disposed within the septum 12 contacts the septum 12, which may create a high tensile force when the introducer needle 18 is withdrawn proximally from the patient and the catheter assembly 10. The large friction between the introducer needle 18 and the septum 12 may cause discomfort to the patient when the introducer needle 18 is withdrawn from the patient and / or may cause the catheter 16 of the catheter assembly 10 to dislodge from the patient's vein.
[0020] Referring next to FIGS. 2A - 2C, in some embodiments, the septum 20 may reduce the tensile force of the introducer needle 22 moving with respect to the septum 20 during proximal withdrawal of the introducer needle 22 from the patient and the catheter assembly 24. In some embodiments, reducing the tensile force may improve patient comfort and may facilitate the success of the first puncture or the placement of the catheter 26 into the vein on the first attempt. In some embodiments, the tensile force may be reduced by decreasing the surface area of the septum 20 that contacts the introducer needle 22. In some embodiments, the proximal end portion of the introducer needle 22 may be secured to a needle hub 27.
[0021] In some embodiments, the septum 20 of the catheter assembly 24 may include a body 28 having a distal end portion 30 and a proximal end portion 32. In some embodiments, the distal end portion 30 of the body 28 and the proximal end portion 32 of the body 28 may be sealed. In some embodiments, the septum 20 may provide a seal for the introducer needle 18 during storage and use of the introducer needle 22, and then seal the catheter assembly 24 when the introducer needle 22 is withdrawn to prevent fluid leakage. In some embodiments, the septum 20 may be pre-slit along the longitudinal axis 36 before inserting the introducer needle 22 through the septum 20. In some embodiments, the septum 20 may not be pre-slit along the longitudinal axis 36.
[0022] In some embodiments, the distal end portion 30 of the body 28 is disposed at a position farthest from the user of the catheter assembly 24 and closest to the patient, functions as a primary seal, and may prevent leakage of blood from the catheter assembly 24. In some embodiments, the proximal end portion 32 of the body 28 may function as a secondary seal to prevent leakage of blood from the catheter assembly 24. In some embodiments, the distal end portion 30 and / or the proximal end portion 32 may wipe the introducer needle 22 when it is withdrawn. In some embodiments, the septum 20 may be composed of an elastomer or an elastic material. In some embodiments, the septum 20 may be composed of silicone and / or rubber. In some embodiments, the septum 20 may result in less material usage and cost savings. In some embodiments, the septum 20 may be formed monolithically as a single unit. In some embodiments, the septum 20 may include a one-piece or multi-piece septum.
[0023] In some embodiments, the septum 20 may include a slot 34 disposed within the outer surface of the body 28 and oriented along the longitudinal axis 36 of the body. In some embodiments, the slot 34 may include a distal end 38 spaced from the distal end 30 of the body 28 and a proximal end 40 spaced from the proximal end 32 of the body 28. In some embodiments, the introducer needle 22 may extend through the slot 34. In some embodiments, the introducer needle 22 may be spaced from the bottom 42 of the slot 34. In some embodiments, the slot 34 may reduce the friction of the introducer needle 22. In some embodiments, the septum may contact the introducer needle only at the distal end 30 and the proximal end 32 of the body 28. In some embodiments, the slot 34 may have various shapes. In some embodiments, the slot 34 may be rectangular as a whole. In some embodiments, the side surface of the slot 34 disposed between the distal end 38 and the proximal end 40 may be straight, as illustrated in FIG. 2A for example, or may have another shape.
[0024] In some embodiments, the catheter assembly 24 may include a catheter adapter 44 and a catheter 26. In some embodiments, the catheter assembly 24 may include a PIVC catheter assembly, and the catheter 26 may include a PIVC. In some embodiments, the catheter assembly 24 may include an integrated catheter system having an integrated extension tube 46 extending from a side port of the catheter adapter 44. In these and other embodiments, the septum 20 may be disposed within the catheter adapter 44 and may be configured for single use. In further detail, in some embodiments, when the catheter assembly 24 is in the insertion position for insertion into a patient, the introducer needle 22 may penetrate the septum 20, but after the catheter 26 is disposed within a vein and the introducer needle 22 is withdrawn proximally through the septum, the septum 20 may remain closed.
[0025] In some embodiments, the length 48 of the slot 34 may correspond to more than half of the length 50 of the body 28. In some embodiments, the depth 52 of the slot 34 may be greater than half of the width 54 of the body 28, which may prevent a portion of the introducer needle 22 extending through the slot 34 from contacting the slot 34. In some embodiments, the septum 20 may be disposed within the catheter adapter 44 in various orientations. FIG. 2C illustrates the septum 20 with the slot 34 facing the side surface of the catheter adapter 44 when the catheter assembly 24 is in the insertion position. In other embodiments, when the catheter assembly 24 is in the insertion position, the slot 34 may face the top or bottom of the catheter adapter 44. In some embodiments, the inner surface of the catheter adapter 44 may seal the slot 34.
[0026] In some embodiments, the septum 20 may include a groove 56, which may be disposed within the outer surface of the body 28 and may be semi-circular. In some embodiments, the groove 56 may facilitate securing of the septum 20 within the catheter adapter 44. For example, the catheter adapter 44 may include a protrusion or similar element that fits within the groove 56. In some embodiments, the groove 56 may extend around a portion of the perimeter of the body 28. In some embodiments, the slot 34 may extend between a first end 58 of the groove 56 and a second end 60 of the groove 56. In some embodiments, the septum 20 may be at least partially disposed within the septum housing.
[0027] Next, referring to FIGS. 2D-2E, in some embodiments, at the insertion position, the bevel of the introducer needle 22 may face upward, and the slot 34 may face downward or toward the bottom of the catheter adapter 44. In some embodiments, for example, as illustrated in FIGS. 2D-2E, the slot 34 may face downward such that droplets of blood disposed within the slot 34 and from the introducer needle 22 are hidden from the patient. In some embodiments, the slot 34 may be filled with a lubricant, which may reduce the appearance of droplets of blood to the patient and may also reduce the tensile force.
[0028] Next, referring to FIGS. 3A-3B, in some embodiments, the catheter assembly 62 may include a septum 64. In some embodiments, the catheter assembly 62 may include or correspond to the catheter assembly 24 of FIG. 2. In some embodiments, the catheter assembly 62 may include one or more features or elements of the catheter assembly 24. In some embodiments, the catheter assembly 24 may include one or more features or elements of the catheter assembly 62. In some embodiments, the septum 64 may include or correspond to the septum 20 of FIG. 2. In some embodiments, the septum 64 may include one or more features of the septum 20. In some embodiments, the septum 20 may include one or more features of the septum 64.
[0029] Next, referring to FIGS. 3C - 3F, in some embodiments, the septum 62 may be at least partially disposed within the septum housing 66. In some embodiments, the inner surface of the septum housing 66 may seal the slot 34 of the septum 62. In some embodiments, the septum housing 66 may provide compression to the septum 62. In some embodiments, the septum housing 66 may be a separate component or alternatively may be an area of the catheter adapter 44. In some embodiments, the septum housing 66 may include a cannister that provides radial compression. In some embodiments, the radial compression from the cannister serves to ensure that the septum 62 conforms to the shape of the introducer needle 22 through which it is inserted and seals tightly upon withdrawal of the introducer needle 22. In some embodiments, the septum 62 may be held in place by compression alone, by mechanical attachment or interlock, and / or by an adhesive as known to those of skill in the art. FIG. 3E illustrates the partially withdrawn needle 22 according to some embodiments.
[0030] Next, referring to FIGS. 4A-4D, in some embodiments, the septum 70 of the catheter assembly 72 may include a channel 74, which may be disposed within the septum 70 and oriented along the longitudinal axis 36 of the body 28. In some embodiments, the catheter assembly 72 may include or correspond to the catheter assembly 24 of FIG. 2 and / or the catheter assembly 62 of FIG. 3. In some embodiments, the catheter assembly 72 may include one or more features or elements of the catheter assembly 24 and / or the catheter assembly 62. In some embodiments, the catheter assembly 24 and / or the catheter assembly 62 may include one or more features or elements of the catheter assembly 72. In some embodiments, the septum 70 may include or correspond to the septum 20 of FIG. 2 and / or the septum 64 of FIG. 3. In some embodiments, the septum 20 and / or the septum 64 may include one or more features of the septum 70. In some embodiments, the septum 70 may include one or more features of the septum 20 and / or the septum 64.
[0031] In some embodiments, the septum 70 may be formed monolithically as a single unit. In some embodiments, the channel 74 may be formed by the inner surface of the body 28. In some embodiments, the introducer needle 22 may extend through the channel. In some embodiments, the introducer needle 22 may be spaced from the inner surface of the body 28. In some embodiments, at least a portion of the channel 74 may be generally cylindrical. In some embodiments, the distal end and / or proximal end of the channel 72 may be tapered. In some embodiments, the length of the channel 74 may correspond to a majority of the length of the body 28.
[0032] In some embodiments, the septum 70 may include a slit 76 that extends from the outer surface of the body 28 toward the channel 74. In some embodiments, the slit 76 may be aligned with the longitudinal axis 36 of the body 28. In some embodiments, the slit 76 may be closed in response to the septum 70 being disposed within the lumen of the catheter adapter 44, which may compress the septum 70. In some embodiments, the slit 76 may extend over the length of the body 28. In some embodiments, the slit 76 may partially extend through the length of the body 28. In some embodiments, the slit 76 may be disposed at the center of the body 28. In some embodiments, the septum 70 may or may not include the groove 56.
[0033] In some embodiments, the septum 70 may include a groove 56, which may be annular or semi-annular, and which may facilitate securing of the septum 70 within the catheter adapter. In some embodiments, the slit 76 may extend through the groove 56. In some embodiments, the septum 70 may be formed by injection molding. In some embodiments, the septum 70 may be molded in an inflated position with the slit open to enable insertion into the undercut-shaped slit 76 of the mold and formation of the channel 74. In some embodiments, the elastomeric material of the septum 70 may enable removal of the undercut shape from the channel 74 through the slit 76 following injection molding.
[0034] Referring now to FIGS. 5A - 5F, according to some embodiments, another catheter assembly 78 is illustrated. In some embodiments, the catheter assembly 78 may include a septum holder 80, which may include a head 82 and a body 84. In some embodiments, the outer diameter of the head 82 may be smaller than the outer diameter of the body 84 such that an annular flange 86 is disposed between the head 82 and the body 84. In some embodiments, when the septum holder 80 is disposed within the lumen 88 of the catheter adapter 44, the head 82 may be disposed at the distal end with respect to the body 84. In some embodiments, the head 82 may be generally cylindrical in shape. In some embodiments, the body 84 may be generally conical in shape with a tapered outer surface. In some embodiments, the outer surface of the body 84 may be tapered outwardly in the proximal direction.
[0035] In some embodiments, the head 82 may be sized and configured to fit snugly within the cavity 90 or pocket of the septum 92. In some embodiments, the cavity 90 may be cylindrical in shape. In some embodiments, the outer diameter of the septum 92 may be slightly smaller than the diameter of the cavity 90. In some embodiments, the outer diameter of the septum 92 may be equal to or slightly larger than the diameter of the cavity 90, and the septum holder 80 may be interference - fitted with the septum 92. In some embodiments, the proximal end portion 94 of the septum 92 may contact the annular flange 86 of the septum holder 80. In some embodiments, the septum holder 80 and / or the catheter adapter 44 may be constructed of a plastic material or another suitable material.
[0036] In some embodiments, the septum holder 80 may facilitate securing of the septum 92 within the lumen 88 of the catheter adapter 44. In further detail, in some embodiments, the inner wall of the catheter adapter 44 that forms the lumen 88 may include one or more protrusions 96, which contact the outer surface of the body 84 to sandwich and hold the body 84 in place, thereby also securing the septum 92. In some embodiments, the protrusions 96 may be annular. In some embodiments, one or more sides of the protrusions 96 may include an undercut. In some embodiments, the protrusions 96 may include two opposing protrusions. In some embodiments, the protrusions 96 may be arranged equidistantly or non-equidistantly around the perimeter of the inner wall that forms the lumen 88. In some embodiments, the outer diameter of the body 84 aligned with the protrusions 96 may be made larger than the distance between the protrusions 96 to facilitate the sandwiching action.
[0037] In some embodiments, the septum 92 and the septum holder 80 may reduce the tensile force on the introducer needle 22 when the introducer needle 22 is withdrawn in the proximal direction. In further detail, the septum holder 80 may allow for a reduced area of the septum 92 that the introducer needle 22 passes through and contacts. In some embodiments, the septum holder 80 may include a passageway 98 that extends therethrough. In some embodiments, when the catheter assembly 78 is in the inserted position and / or when the introducer needle 22 is being withdrawn, the introducer needle 22 may extend through the passageway 98 and / or may be spaced apart from the walls of the passageway 98 along all or a portion of the length of the passageway 98. In some embodiments, a portion of the introducer needle 22 disposed within the passageway 98 may be surrounded by an annular space. In some embodiments, the outer diameter of the introducer needle 22 may be smaller than the diameter of the passageway 98. In some embodiments, there may be no contact between the wall forming the passageway 98 and the introducer needle 22.
[0038] In some embodiments, the septum 92 may include a flange 100, which may contact one or more corresponding flanges 102 of the catheter adapter 44, which may facilitate securing of the septum 92. In some embodiments, the corresponding flange 102 of the catheter adapter 44 may prevent distal movement of the septum 92, and the septum holder 80 may prevent proximal movement of the septum 92. In some embodiments, one or more of the following may facilitate securing of the septum 92 within the lumen 88, which may enhance the liquid seal of the septum 92: contact or interference between the flange 100 and the corresponding flange 102, contact or interference between the head 82 of the septum holder 80 and the septum 92, and contact or interference between the body 84 of the septum holder 80 and the protrusion 96.
[0039] In some embodiments, the distal end 30 of the septum 92 may be flush or substantially flush with the Y-channel of the catheter adapter 44, which may facilitate flushness and reduce dead space for blood. In some embodiments, the distal end 30 of the septum 92 may include a slit 104. In some embodiments, the septum 92 may be pre-slit or the slit 104 may be formed by the introducer needle 22 during assembly. In some embodiments, all or a portion of the slit 104 may be coated, for example, with parylene or another suitable hydrophobic coating. In some embodiments, the hydrophobic coating may reduce the coefficient of friction when the introducer needle 22 is withdrawn proximally from the catheter assembly 78. In some embodiments, a combination of the hydrophobic coating disposed within the slit 104 and a reduction in the contact area of the introducer needle 22 with respect to the septum 92 may reduce the tensile force applied to the introducer needle 22 when the introducer needle 22 is withdrawn proximally from the catheter assembly 78.
[0040] In some embodiments, all or part of the wall of passageway 98 may be coated with a high viscosity lubricant 106, which may be non-migrating. In some embodiments, the high viscosity lubricant 106 may be applied to the proximal end portion of passageway 98. In some embodiments, the high viscosity lubricant 106 may at least partially occlude and cover the notch 108 of the introducer needle 22 when the introducer needle 22 is being withdrawn, which may prevent blood leakage. In some embodiments, the high viscosity lubricant 106 may reduce the tensile force when the introducer needle 22 is withdrawn proximally from the catheter assembly 78.
[0041] It is understood that in some embodiments, the catheter assembly 78 may include or correspond to one or more features or elements of the catheter assembly 24 of FIG. 2, the catheter assembly 62 of FIG. 3, or the catheter assembly 72 of FIG. 4. In some embodiments, the catheter assembly 78 may include one or more features or elements of the catheter assembly 24, the catheter assembly 62, and the catheter assembly 72. For example, in some embodiments, the septum 92 may include or correspond to one or more features or elements of the septum 20 of FIG. 2, the septum 64 of FIG. 3, and the septum 70 of FIG. 4. In some embodiments, one or more features or elements of the catheter assembly 78, the catheter assembly 24, the catheter assembly 62, and the catheter assembly 72 may be included.
[0042] The language of all of the examples and conditions described herein is intended for the educational purpose of aiding the reader's understanding of the invention and the concepts contributed by the inventor for the further development of the technology, and should be construed as not being limited to such specifically described examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention.
Claims
1. A peripheral intravenous catheter assembly comprising: a catheter adapter; a septum disposed within the lumen of the catheter adapter, the septum comprising a body having a distal end portion and a proximal end portion, the distal end portion and the proximal end portion of the body being sealed; a channel disposed within the septum and oriented along the longitudinal axis of the body, the channel being formed by the inner surface of the body; a slit extending from the outer surface of the body toward the channel, the slit being oriented along the longitudinal axis of the body, the slit being closed when the septum is disposed within the lumen of the catheter adapter, the septum being formed monolithically as a single unit; an introducer needle extending through the channel, the introducer needle being spaced from the inner surface of the body; wherein the septum is an elastomer; and wherein the septum is molded in an inflated position with the slit open to enable formation of the channel.
2. A peripheral intravenous catheter assembly comprising: a catheter adapter; a septum disposed within the lumen of the catheter adapter, the septum comprising a body having a distal end portion and a proximal end portion, the distal end portion and the proximal end portion of the body being sealed; a channel disposed within the septum and oriented along the longitudinal axis of the body, the channel being formed by the inner surface of the body; a slit extending from the outer surface of the body toward the channel, the slit being oriented along the longitudinal axis of the body, the slit being closed when the septum is disposed within the lumen of the catheter adapter, the septum being formed monolithically as a single unit; an introducer needle extending through the channel, the introducer needle being spaced from the inner surface of the body; wherein the slit extends partially along the length of the body.
3. The peripheral intravenous catheter assembly according to claim 1, wherein the slit is disposed at the center of the body.
4. The peripheral intravenous catheter assembly of claim 1 , wherein at least a portion of the channel is generally cylindrical.
5. The peripheral intravenous catheter assembly of claim 1 , wherein the length of the channel corresponds to a majority of the length of the body.
6. 10. The peripheral intravenous catheter assembly of claim 1, further comprising a semi-annular or annular groove disposed within the body, the semi-annular or annular groove extending around a portion of the circumference of the body, and the slit extending through the semi-annular or annular groove.
7. The peripheral intravenous catheter assembly of claim 1 , wherein the catheter adapter includes a side port with an integrated extension tube.
Citation Information
Patent Citations
Catheter with low resistance septum
JP2004528127A
Integrated low resistance bulkhead
JP2009513267A
Integrated vascular delivery system with safety needle
JP2013529116A
Low-resistance, high-pressure bulkhead
JP2015508010A
Method and device for maintaining a seal
US20020007152A1