Fluid connector for vascular access device
The fluid connection device with a toothed gripping and sealing system addresses the challenges of misalignment and leakage in VAD connections by providing a secure, leak-proof attachment and easy detachment mechanism for catheters and access ports.
Patent Information
- Application Number
- JP2023509832
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-08-14
- Filing Date
- 2021-08-12
- Publication Date
- 2025-11-17
- Estimated Expiration
- 2041-08-12
AI Technical Summary
Current methods for connecting a vascular access device (VAD) to a catheter involve stretching the catheter over the access port stem, leading to incorrect assembly, misalignment, and potential tissue trauma, while also risking fluid leakage.
A fluid connection device with a toothed gripping connector system and a sealing member to securely attach the catheter to the access port, featuring a recess with radially inward teeth and a sealing member to prevent longitudinal movement and ensure a fluid-tight seal, combined with a quick-release connector for easy detachment.
Facilitates a secure, leak-proof connection between the catheter and access port, reducing slippage and trauma, and allowing for quick and easy assembly within a tissue pocket.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present disclosure relates to fluid connectors for vascular access devices. [Background technology]
[0002] Current methods for fluidly connecting a vascular access device (VAD), such as an access port having one or more reservoirs, to a catheter involve stretching the catheter over the access port stem. This creates challenges when placing the catheter, access port, and port stem within a patient's subcutaneous tissue pocket. Furthermore, stretching the catheter over the port stem within the subcutaneous pocket can lead to incorrect assembly, misalignment, and accidental trauma to the tissue pocket. A more secure connection allows for higher fluid flow between the catheter and the port while preventing fluid leakage from the connection. Therefore, it would be beneficial to quickly, easily, and reliably connect a catheter and an access port within a subcutaneous pocket. Summary of the Invention [Problem to be solved by the invention]
[0003] The present disclosure is a connection system and method of use that addresses the above-mentioned challenges. [Means for solving the problem]
[0004] In some embodiments, a fluid connection device configured to connect a catheter to an access port disclosed herein includes a toothed gripping connector system configured to hold an end of the catheter, the toothed gripping connector system further including a recess extending longitudinally from a first end of the fluid connection device and including an inner stem, the fluid connection device including a gripping member including a plurality of teeth extending radially around and radially inwardly from the inner stem, the plurality of teeth configured to engage an outer surface of the end of the catheter to prevent longitudinal movement in at least a first direction after insertion of the end of the catheter into the recess, and a sealing member configured to act on the outer surface of the catheter to provide a seal between the end of the catheter and the inner stem.
[0005] In some embodiments, the fluid connection device further includes a male end quick connector disposed at a second end of the connection device and configured to engage a female end quick connector connected to the access port.
[0006] In some embodiments, in the fluid connection device, the plurality of tines are angled toward a second end of the connection device opposite the first end. In some embodiments, in the fluid connection device, one of the gripping member or the sealing member is held within a groove in the wall of the recess, the groove extending annularly around the inner stem.
[0007] In some embodiments, the fluid connection device comprises a protrusion extending radially inward from a wall of the recess and configured to abut one of the gripping member or the sealing member to prevent longitudinal movement in at least a first direction.
[0008] In some embodiments, in the fluid connection device, the sealing member comprises one of a silicone, polymer, elastomer, or rubber material that exhibits fluid-tight properties. In some embodiments, in the fluid connection device, the sealing member is disposed proximate the first end and the gripping member is disposed proximate the second end.
[0009] In some embodiments, in the fluid connection device, the sealing member is disposed proximate the second end and the gripping member is disposed proximate the first end. In some embodiments, the fluid connection device further includes a tool, a portion of which is configured to extend into the recess between the outer surface of the catheter and one of the plurality of teeth to disengage the plurality of teeth from the catheter and enable the catheter to be withdrawn along the first longitudinal direction.
[0010] A method for fluidly connecting and positioning a catheter and an access port disclosed herein includes positioning the access port within a tissue pocket, positioning a distal end of the catheter at a target location within a patient, and inserting the proximal end of the catheter into a toothed grip connector system disposed at a first end of a fluid connection device, the toothed grip connector system including a recess, an inner stem disposed within the recess, a gripping member extending annularly around the inner stem, and a sealing member, the gripping member including a plurality of teeth extending radially inward and configured to engage an outer surface of the catheter to prevent withdrawal of the catheter from the toothed grip connector device.
[0011] In some embodiments, in the method, the fluid connection device is integrally formed with the port and configured to provide fluid communication to the port. In some embodiments, in the method, the second end of the connection device is configured to engage the port using one of a quick connect device, a threaded engagement, a press fit, a snap fit, an adhesive, bonding, or welding to provide fluid communication to the port.
[0012] In some embodiments, the method further comprises applying a surface of the sealing member to an outer surface of the catheter and forming a seal between the inner surface of the catheter and the inner stem. In some embodiments, the method further comprises sliding a disengagement tool into a recess between the plurality of tines and the outer surface of the catheter, bending the plurality of tines radially outward to disengage them from the outer surface of the catheter, and withdrawing the catheter from the toothed grip connector system.
[0013] In some embodiments, the method includes the gripping member having a bistable configuration including a first stable configuration in which the plurality of tines are angled toward the second end of the fluid connection device and a second stable configuration in which the plurality of tines are angled toward the first end of the fluid connection device.
[0014] In some embodiments, in the method, the second end of the connection device includes a male end quick connector configured to connect with a female end quick connector on the port.
[0015] In some embodiments, in the method, the second end of the connection device includes a female end quick connector configured to connect with a male end quick connector on the port.
[0016] A method for connecting a catheter to an access port disclosed herein comprises forming a port pocket in a patient and disposing an access port within the port pocket, the access port including a female connector fitting. The method comprises placing a distal end of a catheter at a target location within the patient and inserting a proximal end of the catheter into a connection device outside the port pocket, the connection device including a first end designed to receive the proximal end of the catheter, the first end including a gripping member that prevents movement of the catheter away from the connection device after the proximal end of the catheter is inserted into the first end, and a second end opposite the first end, the second end including a male connector fitting. The method comprises inserting the male connector fitting into the female connector fitting within the port pocket to lock the connection device to the access port and disposing the catheter in fluid communication with the access port.
[0017] A fluid connection system configured to connect a catheter disclosed herein to an access port includes a male end quick connector including an outer stem extending along a longitudinal axis and defining a lumen, the outer stem including a groove extending annularly therearound, and a female end quick connector defining a lumen and configured to receive the stem of the male end quick connector. The female end quick connector includes a collar locking mechanism slidably engaged with the female end quick connector, the collar locking mechanism being transitionable between a locked configuration and an unlocked configuration and including a tab configured to engage the groove in the locked configuration to releasably retain the stem within the female end quick connector.
[0018] In some embodiments, the fluid connection device further includes a biasing member configured to bias the collar locking mechanism into the locked position. In some embodiments, the fluid connection device further includes a guide structure configured to guide the collar locking mechanism between the unlocked configuration and the locked configuration.
[0019] In some embodiments, the fluid connection device further includes an actuator disposed within the lumen of the female end quick connector and configured to open a valve, the valve configured to control fluid communication between the lumen of the female end quick connector and the lumen of the male end quick connector.
[0020] In some embodiments, in the fluid connection device, the male end quick connector is connected to the catheter and the female end quick connector is connected to the port. In some embodiments, in the fluid connection device, the female end quick connector is connected to the catheter and the male end quick connector is connected to the port.
[0021] In some embodiments, the fluid connection device includes a male end quick connector connected to a fluid connection device that includes a toothed grip connector device disposed at an opposite end thereof and configured to engage a catheter.
[0022] In some embodiments, in the fluid connection device, the collar locking mechanism is slidably engaged with the female end quick connector along an axis extending parallel to the longitudinal axis. In some embodiments, in the fluid connection device, the collar locking mechanism is slidably engaged to the female end quick connector along an axis extending perpendicular to the longitudinal axis.
[0023] These and other features of the concepts provided herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which set forth in more detail certain embodiments of such concepts. [Brief explanation of the drawings]
[0024] [Figure 1] 1 illustrates an example of an environment of use including an access port having a port stem, a connection system, and a catheter, according to some embodiments. [Figure 2A]1 is a cross-sectional side view of a connection system according to some embodiments. [Figure 2B] 1 is a cross-sectional side view of a connection system according to some embodiments. [Figure 2C] FIG. 10 illustrates a catheter end view of a toothed grip connector system according to some embodiments. [Figure 3A] FIG. 10 is a side view of a fluid connection device connected to a catheter and engaging an access port, according to some embodiments. [Figure 3B] FIG. 10 is a side view of a fluid connection device connected to a catheter and engaging an access port, according to some embodiments. [Figure 4A] 1 is a side view of an access port including a female end quick connector of a quick release connector system according to some embodiments. [Figure 4B] 4B is a perspective view of the access port of FIG. 4A including a female end quick connector in a locked configuration according to some embodiments. [Figure 4C] 4B is an end view of the access port of FIG. 4A including a female end quick connector in an unlocked configuration according to some embodiments. [Figure 5A] 1A-1C are side cross-sectional views illustrating an example of a method for connecting a catheter to an access port using a connection system according to some embodiments. [Figure 5B] 1A-1C are side cross-sectional views illustrating an example of a method for connecting a catheter to an access port using a connection system according to some embodiments. [Figure 5C] 1A-1C are side cross-sectional views illustrating an example of a method for connecting a catheter to an access port using a connection system according to some embodiments. [Figure 5D] 1A-1C are side cross-sectional views illustrating an example of a method for connecting a catheter to an access port using a connection system according to some embodiments. [Figure 6] 1 is a flowchart illustrating an example of a method of using the connection system according to some embodiments. [Figure 7A] 1 illustrates an example environment of use including a connection system for connecting a catheter to an access port in a tissue pocket, according to some embodiments. [Figure 7B] 1 illustrates an example environment of use including a connection system for connecting a catheter to an access port in a tissue pocket, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION
[0025] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiment and optionally combined or substituted with any of the other several embodiments disclosed herein.
[0026] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and do not limit the scope of the technical concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide sequentiality or numerical limitations. For example, "first," "second," and "third" features or steps need not appear in that order, nor need a particular embodiment including such features or steps be limited to those three features or steps. Designations such as "left," "right," "top," "bottom," "front," "rear," and similar terms are used for convenience and are not intended to imply, for example, a specific, fixed position, orientation, or the like. Rather, such designations are used to reflect, for example, relative position, orientation, or the like. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.
[0027] For example, references to the "proximal," "proximal portion," or "base end" of a catheter disclosed herein include the portion of the catheter intended to be located closer to the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be located closer to the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be located closer to the clinician when the catheter is used on a patient. The proximal portion, proximal end, or proximal length of a catheter may include the proximal end of the catheter. However, the proximal portion, proximal end, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end, or proximal length of a catheter is not the distal portion or distal length of the catheter.
[0028] For example, references to the "distal," "distal portion," or "tip" of a catheter disclosed herein include the portion of the catheter intended to be located near or within a patient when the catheter is used with a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be located near or within a patient when the catheter is used with a patient. For example, the "distal end" of a catheter includes the end of the catheter intended to be located near or within a patient when the catheter is used with a patient. The distal portion, tip, or distal length of a catheter may include the distal end of the catheter. However, the distal portion, tip, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, tip, or distal length of a catheter is not the terminal portion or length of the catheter.
[0029] Unless defined otherwise, all technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.
[0030] FIG. 1 is a perspective view of an environment of use for a connection system (system) 100 including an access port 130 having an access port trunk (port trunk) 132 and a catheter 128 connected to the port 130. In some embodiments, the access port 130 comprises a body 131 defining a reservoir 180 and including a needle-penetration septum 170 on the reservoir 180. In some embodiments, the access port 130 further comprises a port trunk 132 extending from a side of the body 131 and defining a trunk lumen 182 that provides fluid communication between the catheter lumen 160 and the reservoir 180. In some embodiments, the catheter 128 is fluidly connected to the access port 130 by biasing the catheter 128 longitudinally on the port trunk. In one embodiment, the catheter 128 elastically deforms radially outward to stretch on the port trunk. In one embodiment, a user exchanges the catheter 128 by removing the catheter 128 from the port 130 while the access port 130 remains in place within the tissue pocket. A new catheter is then placed and connected to port 130. However, stretching catheter 128 over the port stem as described above presents difficulties, especially when performed within a tissue pocket.
[0031] In one embodiment, the connection system 100 is used to securely connect the catheter 128 to the port stem 132, allowing for increased fluid flow between the catheter 128 and the access port 130 while preventing fluid leakage from the connection. In some embodiments, the connection system 100 comprises a toothed-grip connector system 104 configured to connect the catheter 128 to the connection system 100 and a quick-release connector system 106 configured to connect the access port 130 to the connection system 100. In one embodiment, the connection system 100 can be connected to the catheter 128 by biasing the connection system 100 in a first axial direction A that is substantially parallel to the longitudinal axis. The catheter 128 and connection system 100 can then be connected to the access port 130 by biasing the catheter 128 and connection system 100 in a second axial direction B that is substantially parallel to the longitudinal axis.
[0032] 2A-2B show details of connection system 100. FIG. 2A shows a side cross-sectional view of connection system 100 providing fluid communication between catheter 128 and access port 130. In one embodiment, connection system 100 generally comprises a toothed-grip connector system 104 and a quick-release connector system 106. In one embodiment, toothed-grip connector system 104 is configured to engage the proximal end of catheter 128, and quick-release connector system 106 is configured to releasably engage access port 130. In one embodiment, connection system 100 is integrally formed with catheter 128 and releasably engages access port 130, as described herein. In one embodiment, connection system 100 is integrally formed with access port 130 and selectively engages catheter 128, as described herein. In one embodiment, toothed-grip connector system 104 is configured to engage catheter 128, and quick-release connector system 106 is configured to engage access port 130. In one embodiment, toothed grip connector system 104 is configured to engage with access port 130 and quick release connector system 106 is configured to engage with catheter 128. However, it will be understood that other numbers or combinations of toothed grip connector systems 104 or quick release connector systems 106 may be configured to engage with one or more of catheter 128 and port 130 without departing from the spirit of the present invention.
[0033] Advantageously, the connection system 100 provides a faster and simplified connection between the catheter 128 and the access port 130, further reducing slippage, trauma, and fluid leakage under pressure within the tissue pocket. The connection between the catheter 128, the connection system 100, and the port stem 132 can be quickly and easily made within the tissue pocket, ensuring proper fluid communication between the catheter 128 and the access port 130.
[0034] The connection system 100 generally comprises a connector body 102 extending between a first end 144 and a second end 146. In some embodiments, the first end 144 is proximate the catheter 128, and the second end 146 is proximate the port stem 132. In one embodiment, the first end 144 comprises a toothed-grip connector system 104, and the second end 146 comprises a quick-release connector system 106. For ease of explanation, embodiments of the connection system 100 are described for connecting a single-lumen catheter. However, it should be understood that in some embodiments, the connection system 100 may be designed to connect two or more lumens of the catheter 128 with two or more lumens of the port stem 132. These and other configurations of multi-lumen catheter connectors are considered to be within the scope of the present invention.
[0035] The toothed grip connector system 104 has a recess 152 having a first opening 108 defining a first opening inner diameter 112. In some embodiments, the first opening inner diameter 112 is larger than the outer diameter of the catheter 128 and is configured to receive a portion of the catheter 128 therein. In some embodiments, the toothed grip connector system 104 is configured to selectively secure a portion of the catheter 128 within the recess 152 and provide a fluid-tight seal between the catheter 128 and the connection system 100, as described in more detail herein. In one embodiment, the quick release connector system 106 has a second opening 110 defining a second opening inner diameter 114. In some embodiments, the second end 146 has a male end quick connector 116 that mates with a female end quick connector 142 of the access port 130 as part of the quick release connector system 106, as described in more detail herein.
[0036] 2B shows a side cross-sectional view of a connection system 100 including a toothed-grip connector system 104 at a first end 144. The toothed-grip connector system 104 includes a recess 152, an inner stem 118, a gripping member 124, and a sealing member 122. The recess 152 extends longitudinally from the first end 144 of the elongate body 102 to the inner shoulder 138. The inner stem 118, the gripping member 124, and the sealing member 122 are disposed in the recess 152. The inner stem 118 extends longitudinally from the inner shoulder 138 toward the first end 144 and defines a portion of a connector body lumen 190. The connector body lumen 190 defined by the inner stem 118 defines an inner diameter 136. In some embodiments, the inner diameter 136 of the inner trunk 118 may be equal to or slightly smaller than the diameter 114 of the second opening 110 to maintain high fluid flow between the second end 146 and the first end 144. In some embodiments, the connector body lumen 190 extends from the inner trunk 118 to the second opening 110. In some embodiments, the outer diameter 164 of the inner trunk 118 is equal to or slightly larger than the inner diameter 162 of the catheter lumen 160. In this manner, the catheter 128 can fit tightly around the inner trunk 118 with an interference fit. Additionally, the inner trunk 118 can include chamfered edges to facilitate engagement with the catheter lumen 160.
[0037] In some embodiments, the gripping member 124 comprises a gripping member ring (ring) 150 and a plurality of teeth (teeth) 126 extending radially inward from the ring and angled relative to the longitudinal axis. In one embodiment, the teeth 126 are angled toward the first end 144, angled toward the second end 146, or a combination thereof. In one embodiment, the gripping member 124 is configured to allow the teeth 126 to bend radially outward from a rest position. When the catheter 128 is urged into the first end 144, the teeth 126 can bend radially outward to accommodate the catheter 128 therebetween.
[0038] In some embodiments, one or both of the teeth 126 and the gripping member ring 150 are formed from the same material. In some embodiments, one or both of the gripping member ring 150 and the teeth 126 are formed from plastics, polymers, metals, alloys, composite materials, and combinations thereof, imparting elastic or rigid mechanical properties. In one embodiment, the teeth 126 can be formed from a first material and the gripping member ring 150 can be formed from a second material. For example, in some embodiments, the gripping members 124 are stamped from a single piece of metal material or stamped from multiple pieces of metal material and attached together by gluing, bonding, welding, or the like. In some embodiments, the gripping members 124 are injection molded or 3D printed from plastic, synthetic polymers, or the like. In some embodiments, the gripping member ring 150 can be formed from a flexible material, and the teeth 126 can be formed from a rigid metal material and attached to the gripping member ring 150. In some embodiments, the flexibility of the gripping member ring 150 allows the tines 126 to bend radially outward, thereby allowing the catheter 128 to be removed from the connection system 100 .
[0039] In one embodiment, the teeth 126 are angled toward the second end 146, which urges the catheter 128 into the recess 152 and receives it between the teeth 126. The teeth 126 then engage the outer surface 166 of the catheter 128, holding a portion of the catheter 128 between the teeth 126 and the inner trunk 118 and preventing the catheter 128 from being pulled out of the recess 152. In some embodiments, the teeth 126 may or may not contact the inner trunk 118.
[0040] In one embodiment, a user can insert a disengagement tool 200 into the first end 144 to release the catheter 128 from the toothed-grip connector system 104. For example, as shown in FIGS. 2B and 5D , the disengagement tool 200 extends annularly around a portion of the outer surface 166 of the catheter 128 and is slidable into the toothed-grip connector system 104 between the plurality of teeth 126 and the outer surface 166 of the catheter 128. In some embodiments, the disengagement tool 200 includes a slider 202 and a handle portion 204 connected to the slider 202. In some embodiments, the slider 202 is configured to slide along the outer surface 166 of the catheter 128 and to fit between the outer surface 166 of the catheter 128 and the plurality of teeth 126 when the catheter 128 is disposed within the first end 144. The slider 202 is biased into the toothed grip connector system 104 such that the teeth 126 are bent radially outward and the catheter 128 is released from the teeth 126 .
[0041] In one embodiment, the disengager 200 may be separate from the toothed grip connector system 104, as described herein, and may engage with the toothed grip connector system to disengage the catheter 128. In one embodiment, the disengager 200 may be slidably connected to the toothed grip connector system 104 and may be actuated by a button or similar mechanism to disengage the catheter 128.
[0042] In one embodiment, the gripping member 124 has a bistable configuration. In a first stable configuration, the tines 126 are angled toward the second end 146 (e.g., as shown in FIG. 2B ), and in the second stable configuration, the tines 126 are angled toward the first end 144. In one embodiment, in the first stable configuration, with the catheter 128 held therebetween, the gripping members 124 can prevent movement of the catheter 128 toward the first end 144 when a first axial force is applied to the catheter 128. However, when a second axial force greater than the first axial force is applied, the gripping members 124 transition from the first stable configuration to the second stable configuration, thereby allowing the catheter 128 to be withdrawn from the recess 152. Similarly, the gripping members 124 in the second stable configuration can accommodate the end of the catheter 128. The user can hold the catheter 128 by applying a second axial force to urge the catheter 128 into the recess 152 and transition the gripping member 124 from the second stable configuration to the first stable configuration, as described herein.
[0043] In some embodiments, the toothed grip connector system 104 includes a sealing member 122. The sealing member 122 defines a substantially toroidal shape and is formed from silicone, a polymer, an elastomer, rubber, a synthetic polymer, a plastic, an organic non-plastic polymer, a rubber substitute, or other material and is capable of forming a fluid-tight seal between the catheter 128 and the inner wall 220 of the recess 152. In some embodiments, the gripping member 124 and the sealing member 122 are annularly disposed about the inner stem 118 within the recess 152. In some embodiments, the outer periphery of one of the gripping member 124, the sealing member 122, or both, is retained in an annular groove 240 in the inner wall 220 of the recess 152. In one embodiment, one or both of the gripping member 124 and the sealing member 122 are retained within the recess 152 or the annular groove 240 by adhesive, welding, bonding, interference fit, press fit, or snap-fit engagement. In some embodiments, in the disengaged state, the teeth 126 can engage the inner stem 118 to retain the gripping member 124 within the recess 152. In one embodiment, in the disengaged state shown in FIG. 2B, the teeth 126 have a spaced apart relationship relative to the inner stem 118.
[0044] In some embodiments, the gripping member 124 can be secured to the sealing member 122 by adhesive, bonding, welding, or the like. In some embodiments, the gripping member 124 is configured to provide a fluid-tight seal between the catheter 128 and the inner trunk 118. For example, the gripping member ring 150 can comprise a silicone rubber material or the like and can include a plurality of radially extending teeth 126, as described herein. In one embodiment, the gripping member ring 150 provides the sealing action, and the plurality of teeth 126 provides the gripping action. In one embodiment, the gripping member 124 or the sealing member 122 is secured in place by at least one protrusion 120 or similar mechanical means. In some embodiments, the protrusion 120 extends radially inward from the inner wall 220 of the recess 152 and is configured to abut the gripping member 124 and prevent longitudinal movement of the gripping member 124. In some embodiments, the protrusion 120 is configured to abut the sealing member 122 and prevent longitudinal movement of the sealing member 122. In one embodiment, the gripping member 124 or sealing member 122 is secured in place by adhesive, welding, bonding, combinations thereof, or the like.
[0045] 2C shows a catheter end view of a toothed grip connector system 104, according to some embodiments. The toothed grip connector system 104 includes a recess 152 and its inner wall 220. The recess 152 further includes a sealing member 122 and a gripping member 124 disposed between the first end 144 and the sealing member 122. The toothed grip connector system 104 further includes an inner trunk 118 and at least one protrusion 120 configured to abut the gripping member 124 to prevent longitudinal movement thereof. In some embodiments, the gripping member 124 is disposed proximate the first end 144 and the sealing member 122 is disposed proximate the second end 146. In some embodiments, the gripping member 124 is disposed proximate the second end 146 and the sealing member 122 is disposed proximate the first end 144.
[0046] 3A-3B show side views of the connection system 100 engaged with a catheter 128. The connection system 100 includes a quick-release connector system 106 configured to connect the connection system 100 with an access port 130 or similar VAD. In some embodiments, the access port 130 can be positioned within a subcutaneous tissue pocket 134, and the connection system 100 and catheter 128 assembly can be connected to the access port 130 within the tissue pocket 134. In some embodiments, the connection system 100 is attached to the port 130 within the tissue pocket 134. The catheter 128 is then connected to the connection system 100 within the tissue pocket 134. In some embodiments, the connection system 100 is releasably connected to an access port stem 132. In some embodiments, the connection system 100 can be integrally formed with the access port 130, such that the connection system 100 is a substitute for the port stem 132 and provides fluid communication between the catheter 128 and the reservoir 180 of the access port 130 via an access port lumen 182, etc.
[0047] In some embodiments, a quick release connector system 106 can connect the connection system 100 to the access port 130. For example, the quick release connector system 106 includes a male end quick connector 116. The male end quick connector 116 is provided on the connection system 100 and is configured to slidably engage with a female end quick connector 142 provided on the access port 130 to provide fluid communication between the catheter 128 and the access port 130. In some embodiments, the male end quick connector 116 includes an outer stem that extends longitudinally and includes a chamfered edge to facilitate engagement. In some embodiments, the male end quick connector 116 including the outer stem includes a groove 600 that extends longitudinally and is configured to facilitate alignment of the male end quick connector 116 within the female end quick connector 142. The female end quick connector 142 includes a recess that extends longitudinally and is configured to receive the male end quick connector 116.
[0048] In some embodiments, the female end quick connector 142 is disposed on the connection system 100 and the male end quick connector 116 is disposed on the access port 130. In one embodiment, the connection system 100 can be connected to the access port 130 by a threaded engagement, an interference fit, a press fit, or a snap fit engagement, combinations thereof, or the like. In one embodiment, the connection system 100 can be integrally formed with the access port 130. In one embodiment, the connection system 100 is attached to the access port 130 using adhesives, bonding, welding, or the like.
[0049] As shown in FIGS. 3A-3B , in some embodiments, the female end quick connector 142 includes a collar locking mechanism 172 slidably engaged along its longitudinal axis, allowing the female end quick connector 142 to transition between an unlocked configuration, shown in FIG. 3A , and a locked configuration, shown in FIG. 3B . In the unlocked configuration, the male end quick connector 116 of the catheter connection system 100 can be inserted into or withdrawn from the female end quick connector 142 along its longitudinal axis. The collar locking mechanism 172 can transition from the unlocked configuration to the locked configuration to retain the male end quick connector 116 within the female end quick connector 142, connecting the access port 130 with the catheter 128 and the connection system 100 to provide fluid communication therebetween. Locking mechanisms between the female end quick connector 142 and the male end quick connector 116 include pinion and groove, locking lugs, bayonet locking mechanisms, collet chuck locking mechanisms, and the like.
[0050] 4A-4C show various views of one embodiment of a female end quick connector 242. FIG. 4A shows a side view of the female end quick connector 242 of the quick release connector system 106 connected to the access port 130. FIG. 4B shows a perspective view of the female end quick connector 242 in a locked or closed position. FIG. 4C shows a perspective view of the female end quick connector 242 in an unlocked or open position. The female end quick connector 242 is connected to the access port 130 as described herein. In one embodiment, the female end quick connector 242 includes a collar locking mechanism 272 including a collar locking tab 276 and a collar locking spring 278. The collar locking mechanism 272 can be slidably engaged with the female end quick connector 242 along an axis extending perpendicular to the longitudinal axis. For example, the collar locking tab 276 can slide along a transverse axis between a locked position and an unlocked position. A biasing member 278, such as a spring, may bias the collar locking mechanism 272 into the locked position.
[0051] 4B shows a perspective view of the access port 130 of FIG. 4A including the female end quick connector 242 in a locked configuration, according to some embodiments. The collar locking mechanism 272 can include one or more tabs 280, such as a first tab 280A and a second tab 280B. The tabs 280A and 280B can slidably engage a groove 602 or abutment that extends annularly around the male end quick connector 116 to retain the male end quick connector 116 within the female end quick connector 242.
[0052] In one embodiment, the access port lumen 182 includes a port valve 324 connected to an actuator 320. When the male end quick connector 116 engages the female end quick connector 242, a tip, e.g., the second end 146, of the male end quick connector 116 contacts the actuator 320, opening the port valve 324. In one embodiment, the actuator 320 can align the connector body lumen 190 of the connection system 100 with the lumen of the female end quick connector 242.
[0053] In one embodiment, the female end quick connector 242 includes one or more guide structures 322 configured to laterally guide the collar locking mechanism 272 between the unlocked and locked configurations. In this embodiment, the guide structure 322 includes a rounded, cylindrical protrusion 332A. The protrusion 332A extends longitudinally from the female end quick connector 242 and slidably engages the collar locking mechanism 272. In one embodiment, the protrusion 332A is connected to the actuator 320 or the port valve 324. When engaged with the female end quick connector 242, a portion of the male end quick connector 116 can depress the cylindrical protrusion 332A and open the port valve 324. As shown, a collar lock spring 278 biases the collar locking tab 276, and therefore the collar locking mechanism 272, toward the locked configuration.
[0054] 4C illustrates the female end quick connector 242 of FIG. 4A in an unlocked configuration. In this embodiment, the collar lock spring 278 is laterally compressed by the collar lock tab 276, causing the collar lock mechanism 72 to slide along the guide structure 322 into the unlocked configuration to allow engagement with the male end quick connector 116.
[0055] 5A-5D are side cross-sectional views illustrating a method for connecting a catheter 128 to an access port 130 using the connection system 100, according to some embodiments. In one embodiment, the catheter 128 is connected to a fluidic device outside of a patient's tissue pocket 134. In FIG. 5A, the catheter 128 is inserted into the toothed-grip connector system 104 of the connection system 100 and connected as described herein. As shown in FIG. 5B, the catheter 128 is advanced into the recess 152. The catheter lumen 160 accommodates the inner trunk 118 such that the catheter 128 is positioned thereon. The proximal end of the catheter 128 extends through the gripping member 124 and the sealing member 122 and engages the internal shoulder 138. The plurality of teeth 126 of the gripping member 124 engages the outer surface 166 of the catheter 128. In one embodiment, the plurality of tines 126 are angled obliquely toward the second end 146 to grip the outer surface 166 of the catheter 128 and prevent the catheter 128 from being pulled out of the recess 152 .
[0056] In one embodiment, the sealing member 122 engages the outer surface 166 of the catheter 128 to provide a seal between the catheter 128 and the body 102 of the connection system 100. In one embodiment, the sealing member 122 partially compresses the catheter 128 radially inward onto the inner trunk 118 to form a seal therebetween. As shown in FIG. 5B , the gripping member 124 resists any force applied to the catheter 128 to inhibit disengagement of the catheter 128 from the connection system 100. The teeth 126 of the gripping member 124 engage the catheter 128, and the protrusions 120 prevent longitudinal movement of the gripping member 124, which together prevent the catheter 128 and the gripping member 124 from being longitudinally withdrawn from the inner trunk 118. In one embodiment, the gripping member 124 or the sealing member 122 is disposed within an annular groove 240 disposed in the inner wall 220 of the recess 152.
[0057] 5B-5C, the catheter 128 and connection system 100 are then biased longitudinally to engage the male end quick connector 116 with the female end quick connector 142, 242, e.g., the collar lock female end quick connector 142. The collar lock mechanism 172 then transitions to a locked position, thereby securing the male end quick connector 116 within the female end quick connector 142. In one embodiment, the collar lock mechanism 172 is transitioned from the locked position to an unlocked position to selectively release the male end quick connector 116 from the female end quick connector 142.
[0058] 5D , the disengagement tool 200 can slide between the outer surface 166 of the catheter 128 and the teeth 126. The disengagement tool 200 is configured to bend the teeth 126 radially outward, thereby disengaging the teeth 126 from the outer surface 166 of the catheter 128 and allowing the catheter 128 to be withdrawn from the recess 152 of the connection system 100. It should be noted that the gripping member 124 can be configured to bend one or more of the teeth 126, thereby simultaneously bending all of the teeth 126. In one embodiment, the toothed-grip connector system 104 further includes a mechanism (not shown) that, when actuated, causes the teeth 126 to bend radially outward, thereby disengaging the teeth 126 from the outer surface 166 of the catheter 128 and allowing the catheter 128 to be withdrawn from the recess 152.
[0059] 6, 7A, and 7B illustrate a method of using the connection system 100. Referring to FIG. 6, a flow chart illustrates a method of using the connection system 100, according to some embodiments. Each block illustrated in FIG. 6 represents an action performed by a method 500 of using the connection system 100. As a first step in the method 500, a tissue pocket 134 is formed in the patient (block 502). In some embodiments, the tissue pocket 134 may be formed in the patient's chest wall and may be configured to fit the size of the access port 130. However, it will be understood that this is by way of example only, and the tissue pocket 134 may be formed anywhere on the patient.
[0060] In the next step of the method 500, the access port 130 is positioned and secured within the tissue pocket 134 (block 504). In some embodiments, the access port 130 includes a female end quick connector 142 configured to attach to the male end quick connector 116. In some embodiments, the access port 130 includes a male end quick connector 116 configured to attach to the female end quick connector 142.
[0061] The next step in method 500 involves positioning the distal end of catheter 128 at a target location within the patient's vasculature (block 506). For example, in some embodiments, the distal end of catheter 128 is positioned within the inferior vena cava (IVD), or the like.
[0062] In one embodiment, the method 500 includes inserting the proximal end of the catheter 128 into the toothed-grip connector system 104 of the connection system 100 outside the tissue pocket 134 (block 508). Optionally, the proximal portion of the catheter 128 may be trimmed to an appropriate length to facilitate engagement with the connection system 100 / access port 130. Advantageously, the catheter 128 can be sized to a precise length while in position within the patient. This is in contrast to estimating the appropriate length of the catheter prior to placement, which may lead to displacement of the catheter within the vessel.
[0063] The toothed-grip connector system 104, as described herein, includes a gripping member 124 configured to prevent withdrawal of the catheter 128 from the toothed-grip connector system 104, and a sealing member 122 configured to form a fluid-tight seal between the catheter 128 and the inner stem 118. Advantageously, the proximal end of the catheter 128 is urged into the connection system 100 with less force than is required to stretch the catheter 128 over the port stem 132. This allows for accurate assembly of the catheter 128 / port 130 while ensuring securement, a fluid-tight seal, and reduced slippage and traumatic fluid leakage under pressure against the tissue pocket during deployment.
[0064] In one embodiment, the final step of method 500 includes inserting the second end 146 of the connection system 100, which includes the quick release connector system 106 including the male end connector 116, into the female end connector 142 of the port stem 132 within the tissue pocket 134, and securing the collar 172, 272 to lock the connection system 100 to the access port 130 and place the catheter 128 in fluid communication with the access port 130 (block 510).
[0065] In some embodiments, the method 500 includes inserting the second end 146 including the quick release connector system 106 into the access port 130 within the tissue pocket 134 (block 509).
[0066] In some embodiments, the method 500 includes a final step of inserting the catheter 128 into the toothed grip connector system 104 of the connection system 100 within the tissue pocket 134 to place the catheter 128 in fluid communication with the access port 130 (block 511).
[0067] 7A-7B illustrate a use environment for an access port 130 disposed within a patient's tissue pocket 134 and a catheter 128 connected to a connection system 100. In some embodiments shown in FIG. 7A, both the access port 130 and the catheter 128 are implanted in a patient, but the access port 130 is not yet connected to the connection system 100, but is instead both disposed within the tissue pocket 134. As shown in FIG. 7B, the access port 130 can then be connected to the connection system 100 within the patient's tissue pocket 134 to provide fluid communication between the catheter 128 and the access port 130.
[0068] Although some specific embodiments have been disclosed herein, and the specific embodiments have been disclosed in some detail, it is not intended that the specific embodiments limit the scope of the concepts provided herein. Additional improvements and / or modifications may be apparent to those skilled in the art, and the broader aspects encompass these improvements and / or modifications as well. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.
Claims
1. 1. A connection system configured to connect a catheter to an access port, comprising: a connector body extending between a first end and a second end; 1. A toothed grip connector system configured to hold an end of a catheter, comprising: a recess extending longitudinally from the first end and including an internal stem; a gripping connector system comprising: a gripping member extending radially around the inner stem and including a plurality of teeth extending radially inward, the teeth configured to engage an outer surface of the end of the catheter to prevent longitudinal movement in at least a first direction after insertion of the end of the catheter into the recess; a sealing member configured to act on an exterior surface of the catheter to provide a seal between the end of the catheter and the inner stem; a toothed grip connector system including: a quick release connector system configured to releasably engage the access port; Equipped with the first end is provided with a toothed grip connector system; The second end is provided with a quick release connector system.
2. The connection system of claim 1 further comprises: A connection system including a male end quick connector disposed at a second end of the connection system and configured to mate with a female end quick connector connected to the access port.
3. 3. The connection system according to claim 1, A connection system wherein the plurality of teeth are angled toward a second end of the connection system opposite the first end.
4. The connection system according to any one of claims 1 to 3, one of the gripping member or the sealing member is held within a groove in a wall of the recess; The groove extends annularly around the inner stem.
5. The connection system according to any one of claims 1 to 4, a protrusion extending radially inward from a wall of the recess and configured to abut one of the gripping member or the sealing member to prevent longitudinal movement in at least the first direction.
6. The connection system according to any one of claims 1 to 5, A connection system wherein the sealing member comprises one of a silicone, polymer, elastomer, or rubber material that exhibits fluid-tight properties.
7. 3. The connection system according to claim 2, the sealing member is disposed proximate the first end; The gripping member is disposed proximate the second end.
8. 3. The connection system according to claim 2, the sealing member is disposed proximate the second end; The gripping member is disposed proximate the first end.
9. The connection system according to any one of claims 1 to 8 further comprises: A connection system including a disengagement tool, wherein a portion of the disengagement tool is configured to extend into the recess between the outer surface of the catheter and one of the plurality of teeth, thereby disengaging the plurality of teeth from the catheter and allowing the catheter to be withdrawn along the longitudinal direction.
10. 1. A connection system configured to connect a catheter to an access port, comprising: a male end quick connector including an outer stem extending along a longitudinal axis and defining a lumen, the outer stem including a groove extending annularly therearound; a female end quick connector defining a lumen and configured to receive a stem of the male end quick connector, the female end quick connector including a collar locking mechanism slidably engaged with the female end quick connector, the collar locking mechanism being transitionable between a locked configuration and an unlocked configuration and including a tab configured to engage the groove in the locked configuration to releasably retain the stem within the female end quick connector; A connection system comprising:
11. The connection system according to claim 10 further comprises: a biasing member configured to bias the collar locking mechanism into a locked position; and / or A connection system including a guide structure configured to guide the collar locking mechanism between the unlocked configuration and the locked configuration.
12. The connection system according to claim 10 or 11 further comprises: a connection system including an actuator disposed within a lumen of the female end quick connector and configured to open a valve, the valve configured to control fluid communication between a lumen of the female end quick connector and a lumen of the male end quick connector.
13. The connection system according to any one of claims 10 to 12, the male end quick connector is connected to a catheter; The female end quick connector is connected to a port, or the female end quick connector is connected to a catheter; The male end quick connector is connected to a port.
14. The connection system according to any one of claims 10 to 12, A connection system wherein the male end quick connector is connected to a fluid connection device that includes a toothed grip connector system disposed at an opposite end thereof and configured to engage a catheter.
15. The connection system according to any one of claims 10 to 14, The collar locking mechanism is slidably engaged with the female end quick connector along an axis extending parallel or perpendicular to the longitudinal axis.
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