CATHETER SYSTEM TO PROVIDE NEEDLE SAFETY

Abstract

A catheter system protects against needlestick injuries and environmental contamination from exposure to residual blood. The catheter system may include a catheter assembly, a needle assembly, and a housing. The needle assembly may be attached to the catheter assembly and include a needle hub and an introducer needle. The housing may fit within a lumen of the catheter adapter and may include a distal end, a proximal end, and a cavity. The introducer needle may extend through the housing. A safety clamp within the cavity may include an extended arm portion and a barrier feature. The introducer needle may tilt the barrier element outward, away from the longitudinal axis of the introducer needle.In response to proximal retraction of the introducer needle, the barrier element can be configured to move towards the longitudinal axis of the needle and protect the sharp distal tip.

Description

CATHETER SYSTEM TO PROVIDE NEEDLE SAFETY Background of the Invention Intravenous catheters are traditionally used to infuse fluids, such as saline solution, various medications, and / or total parenteral nutrition into a patient. Catheters can also be used to draw blood from a patient and / or monitor various parameters of the patient's vascular system. To insert an intravenous catheter into a patient, a peripheral intravenous (IV) catheter can be mounted onto a hollow introducer needle, which may include a sharp distal tip. The inner surface of the catheter can be tightly fitted to the outer surface of the needle to prevent the catheter from dislodging and to facilitate its insertion into a blood vessel. The tip of the introducer needle can extend beyond the distal tip of the catheter to allow the catheter to be inserted at a shallow angle through the patient's skin and into the blood vessel. To verify correct placement of the needle and catheter in the blood vessel, the healthcare professional may check for backflow in a backflow chamber associated with the catheter and needle assembly. Once correct placement is confirmed, the physician can Ref. 340604 applies pressure to the blood vessel to occlude it, reducing blood flow through the introducer needle and catheter. The clinician can then withdraw the needle from the catheter to allow continued access to the blood vessel through the catheter. This process of physically manipulating and disassembling the needle and catheter after the catheter has been correctly positioned creates substantial risks of accidental needlestick injuries and exposure to blood and bloodborne pathogens. Furthermore, it has been observed that needle withdrawal from a catheter assembly can impart energy to parts of the needle. For example, during introducer needle withdrawal, bending forces (inadvertently or intentionally) can be applied to the needle. These bending forces can cause blood to spurt or spray from the needle as it vibrates and shakes upon release from the catheter assembly, releasing stored energy. Many serious and contagious diseases, such as Ebola and AIDS, can be transmitted through direct contact with the blood of an infected person. Other serious and contagious diseases, such as SARS, MERS, and COVID-19, are airborne and can be contracted simply by breathing in or touching a surface that harbors airborne pathogens, and then touching your eyes, nose, or mouth. In any case, disposing of a used needle increases the risk of environmental contamination due to exposure to residual blood. The subject matter claimed herein is not limited to modalities that resolve any disadvantage or that function only in environments such as those described above. Rather, this background is provided only to illustrate an example of a technological area in which some of the implementations described herein may be practiced. Summary of the Invention This description refers generally to a catheter system for protecting a needle after use, and to related systems and methods. The modalities of a catheter system as described herein can protect against needlestick injuries and prevent environmental contamination from exposure to residual blood. In some modalities, the catheter system may include a catheter assembly, a needle assembly, and a housing. In some modalities, the catheter assembly may include a catheter adapter and a catheter extending distally from the catheter adapter. In some modalities, the needle assembly may be attached to the catheter assembly. The needle assembly may include a needle hub and an introducer needle.In some modalities, the needle hub may be attached to a proximal end of the catheter adapter and a proximal end of the introducer needle may be secured inside the needle hub. In some designs, the housing may be secured within a lumen of the catheter adapter. The housing may include a distal end and a proximal end, where the proximal end is configured to receive a sharp distal tip of the introducer needle through it during assembly. In some designs, the housing may further include a cavity through which a longitudinal shaft of the introducer needle can be extended. In some models, the housing may also include a safety clamp located within the cavity. In some models, the safety clamp may include an extended arm portion and a barrier feature. In some models, the introducer needle may skew the barrier feature outward, away from a longitudinal axis of the introducer needle. In some models, in response to proximal retraction of the introducer needle, the barrier feature may be configured to move toward the longitudinal axis of the needle and protect the sharp distal tip. In some designs, the housing may include a resilient material and / or may be sealed so that the blood is contained within the housing. In some designs, an outer surface of the housing may include one or more retention features configured to engage one or more corresponding fixation features disposed within the lumen. In some designs, the distal end of the housing may be configured to contact or engage with a septum disposed within the lumen to prevent environmental contamination from exposure of residual blood to air. In some designs, the housing cavity may include a reinforcing rib to exert downward force on the safety clamp. This downward force can drive the barrier feature against the longitudinal axis of the introducer needle. In some designs, the cavity may be long enough to accommodate the sharp distal tip and a notch of the introducer needle. In some designs, the cavity may include a trimming feature to reduce friction between the cavity and the introducer needle. In some designs, the safety clamp may be rigid and / or resilient. In some designs, the sharp distal tip of the introducer needle may penetrate the proximal and / or distal end of the housing so that the longitudinal axis of the introducer needle can extend through the cavity. More specifically, in some designs, the sharp distal tip of the introducer needle may be configured to pierce or create a hole through at least one of the proximal and distal ends of the housing so that the longitudinal axis can extend through the cavity. In some models, a catheter system for protecting the needle after use may include a catheter assembly, a needle assembly, and a housing. In some models, the catheter assembly may include the catheter adapter and the catheter extending distally from the catheter adapter. In some models, the needle assembly may be attached to the catheter assembly and may include the needle hub and the introducer needle. In some models, the needle hub may be attached to the proximal end of the catheter adapter. In some models, the proximal end of the introducer needle may be secured within the needle hub. In some designs, the housing may be retained within the lumen of the catheter adapter. In some designs, the housing may include a first resilient element and a second resilient element proximal to the first resilient element. In some designs, the first resilient element may include a coupling element, and the second resilient element may include another coupling element. In some designs, the first resilient element and the second resilient element may each include a proximal and a distal end. The first resilient element may include a first central hole, and the second resilient element may include a second central hole.In some designs, the coupling element and the other coupling element can couple the proximal end of the first resilient element to the distal end of the second resilient element so that the first central hole and the second central hole form a central passage. In some designs, the first and second resilient elements can form a V-shape in response to proximal retraction of the introducer needle near a distal wall of the first resilient element. In some designs, the central passage can be configured to receive the longitudinal axis of the introducer needle through it. In some embodiments, the housing may further include a first outer covering coupled to an outer surface of the first resilient element and / or a second outer covering coupled to an outer surface of the second resilient element. In some embodiments, the first outer covering and / or the second outer covering may each include an opening to receive the introducer needle. In some embodiments, the distal end of the first resilient element may be configured to couple to or contact the septum disposed within the lumen. In some modalities, in response to the introducer needle extending through the central passage within the septum, the V-shape may straighten along its longitudinal axis. In some modalities, in response to the withdrawal of the introducer needle proximal to a distal wall of the first resilient element, the V-shape may form such that the sharp distal tip of the introducer needle is secured within the central passage. In some modalities, the V-shape may further secure the notch of the introducer needle within the central passage. In some embodiments, the first center hole of the first resilient element and / or the second center hole of the second resilient element may be formed by the introducer needle, for example, by piercing or pushing the introducer needle through the first resilient element and / or the second resilient element. In other embodiments, the first center hole and / or the second center hole may be preformed. In some embodiments, the coupling element and / or the other coupling element may each include a protrusion and an opening disposed at one end. It should be understood that both the preceding general description and the following detailed description are examples and explanations and are not restrictive of the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and instruments illustrated in the figures. It should also be understood that the embodiments may be combined, or that other embodiments may be used, and that structural changes, unless claimed, may be made without departing from the scope of some embodiments of the present invention. Therefore, the following detailed description should not be taken in a limiting sense. Brief Description of the Figures The example modalities will be described and explained in greater specificity and detail using the attached figures, in which: Figure 1 is a perspective view of a prior art needle safety device for protecting the tip of a needle; Figure 2 is a cross-sectional view of an example of a catheter system for protecting an introducer needle after use, illustrating an example of an introducer needle in an advanced or insertion position, ready for insertion into a patient, according to some modalities; Figure 3 is an enlarged cross-sectional view of a portion of the catheter system in Figure 2, illustrating an example of an introducer needle tip extending through an example of a septum, according to some modalities; Figure 4 is a cross-sectional view of the catheter system in Figure 2, illustrating the introducer needle in a retracted position, according to some modalities; Figure 5A is a top perspective view of an example of accommodation, which includes an upper portion and a lower portion, according to some modalities; Figure 5B is a perspective view of the accommodation in Figure 5A, which includes an upper portion and a lower portion, according to some modalities; Figure 5C is a cross-sectional view of the housing in Figure 5A, illustrating the introducer needle in the retracted position, according to some modalities; Figure 6A is a perspective view of another example of accommodation, according to some modalities; Figure 6B is a cross-sectional view of the housing in Figure 6A, illustrating the advancement of the introducer needle through it, according to some modalities; Figure 6C is a cross-sectional view of the housing in Figure 6A, illustrating the tip of the introducer needle secured in the housing, according to some embodiments; Figure 7A is a perspective view of an example of a resilient element, according to some modalities; Figure 7B is a perspective view of another example of a resilient element, according to some modalities; Figure 7C is a perspective view of an example of accommodation formed by the resilient element of Figure 7A and the resilient element of Figure 7B, according to some modalities; Figure 7D is a cross-sectional view of the housing in Figure 7C, according to some modalities; Figure 8A is a cross-sectional view of an example of a housing coupled to the septum of the catheter adapter, according to some modalities; and Figure 8B is a cross-sectional view of the housing and septum of Figure 8A, illustrating the tip of the introducer needle secured within the housing, according to some modalities. Detailed Description of the Invention As used in this description, the term distal refers to a portion of a catheter system or component that is farthest from a user, and the term proximal refers to a portion of a catheter system or component that is closest to the user. Thus, for example, the end of a catheter that first touches the patient's body is a distal end of the catheter, while the opposite end of the catheter is a proximal end. As used in this description, the term user may refer to a healthcare professional, physician, nurse, or any other care provider and may include support staff. Figure 1 illustrates a prior art needle safety device 10 used in the medical field. Typically, the prior art needle safety device 10 is retained within a catheter adapter. The needle extends longitudinally through a body 12 of the prior art needle safety device 10 and a distal opening 14 when the needle is in an insertion position for insertion into a patient's vasculature. After the needle and catheter are inserted into the vasculature, the needle is retracted proximally to actuate a spring clip 20, which physically protects a sharp distal tip of the needle to prevent needlestick injury. The needle safety device of prior technique 10 can present several hazards. For example, the needle safety device of prior technique 10 includes gaps 24 and / or other openings 22 that can expose residual blood in the needle directly to the air. When the needle is used to introduce the catheter into the patient's vasculature, residual blood can enter the needle. Some blood may remain in the needle after it is withdrawn from the catheter. During the process of removing the needle from the catheter, residual blood can drip from the needle and potentially contaminate exposed surfaces and / or the air. In fact, exposure to residual blood can transmit airborne pathogens from the patient to the user and / or to surfaces in the surrounding environment. The anterior technique 10 needle safety device is constructed of metal and / or includes one or more sharp edges. This may increase the risk of cuts or scratches to the patient or a healthcare professional, particularly when the anterior technique 10 needle safety device is removed from the catheter adapter. Referring now to Figure 2, a catheter system 26, according to some modalities, can protect against needlestick injuries and prevent environmental contamination from exposure to residual blood. The catheter system 26 can also overcome the disadvantages of the previous technique, as explained in more detail below. In some modalities, the catheter system 26 may include a catheter assembly 28, a needle assembly 30, and a housing 32. In some modalities, catheter assembly 28 may include a catheter adapter 34 and a catheter 36 extending from a distal end of catheter adapter 34. In some modalities, needle assembly 30 may be attached to catheter adapter 34. In some modalities, needle assembly 30 may include a needle hub 40 and an introducer needle 42. In some modalities, the needle hub 40 may be attached to a proximal end of catheter adapter 34, and a proximal end of the introducer needle 42 may be secured within the needle hub 40. In some embodiments, housing 32 may be secured within a lumen 100 of the catheter adapter 34. In some embodiments, housing 32 may include a proximal end 44 and a distal end 46. In some embodiments, the proximal end 44 and the distal end 46 may be configured to receive a sharp distal tip 56 of the introducer needle 42 through them during fabrication of the catheter system 26. In some embodiments, the sharp distal tip 56 may pierce the proximal end 44 and / or the distal end 46 when the introducer needle 42 is moved distally through the catheter assembly 28 during fabrication. In some embodiments, housing 32 may include a cavity 78 to contain or encapsulate a portion of a longitudinal shaft 60 of the introducer needle. In some embodiments, the housing 32 may also include a safety clamp 52 located within the cavity. In some embodiments, the safety clamp 52 may include an elongated arm portion 64, which may be disposed along a longitudinal axis 94 of the introducer needle 42. In some embodiments, the safety clamp 52 may include a barrier feature 54, which may extend from the elongated arm portion 64 and be angled to it. In some embodiments, the barrier feature 54 may extend in a generally transverse direction from a distal end of the elongated arm portion 64. In some embodiments, the barrier feature 54 may extend from the arm portion 64 to and / or the introducer needle 42. In some embodiments, the longitudinal axis may skew the barrier feature 54 and the safety clamp 52 away from the longitudinal axis 94.In some modalities, in response to the sharp distal tip 56 of the introducer needle 42 being retracted proximally beyond a position of the barrier feature 54, the barrier feature 54 may move toward and / or beyond the longitudinal axis 94 to protect the introducer needle 42 and prevent the introducer needle 42 from coming out of the distal end 46 of the housing 32. In some modalities, a first end of the barrier feature 54 may be coupled to the arm portion 64. In some modalities, a second end of the barrier feature 54 may be coupled to an end portion 65 of the safety clamp 52. In some modalities, the end portion 65 may generally be parallel to the longitudinal axis 94 and / or be secured within a groove 67 in response to the sharp distal tip 56 of the introducer needle 42 being retracted proximally past a position of the barrier feature 54 and the end portion 65. In some embodiments, housing 32 may include a flexible or resilient material such as silicone or another suitable material. In some embodiments, the flexible or resilient material may be impermeable to liquid and / or air. In some embodiments, housing 32 may be formed monolithically as a single unit or may include more than one joined or coupled part. In either case, housing 32 may be isolated and / or hermetically sealed to prevent exposure of residual blood to air. In some embodiments, housing 32 may isolate a distal end of the introducer needle 42 contained therein, so that any residual blood in that portion of the introducer needle 42 may be isolated from the atmosphere as well as the external environment.In some embodiments, during manufacturing, the sharp distal tip 56 of the introducer needle 42 may pierce or penetrate the proximal end 44 and / or the distal end 46 of the housing 32 to allow the longitudinal shaft 60 of the introducer needle 42 to extend through the cavity 78 within the housing 32. In some embodiments, an outer surface of the housing 32 may include one or more retention features 96 configured to engage one or more locking features 98 of the catheter adapter 34. In some embodiments, the locking features 98 may be arranged within the lumen 100 of the catheter adapter 34 such that the engagement of the retention features 96 with the locking features 98 secures the housing 32 to the catheter adapter 34. In some embodiments, the retention features 96 may include one or more recesses in the housing 32 configured to engage one or more projections or other locking features 98 in the lumen 100 of the catheter adapter 34. In some embodiments, during manufacturing, the housing 32 may be inserted into a proximal end 44 of the housing 32 and advanced distally within the lumen 100.Thus, in some embodiments, the securing features 98 may be arranged within the retention features 96 such that the retention features 96 engage the securing features 98 to secure the housing 32 to the catheter adapter 34. In some embodiments, the securing features 98 and / or the retention features 96 may be constructed of resilient material or other suitable resilient material. With reference to Figure 3, in some designs, the distal end 46 of the housing 32 can be configured to engage with a proximal end 48 of a septum 38 disposed within the lumen 100. In this way, the housing 32 and the septum 38 can function in combination to prevent environmental contamination from the exposure of residual blood to the atmosphere. For example, in some designs, the introducer needle 42 can be retracted proximally so that a notch 58 of the introducer needle 42 and the sharp distal tip 56 can be withdrawn within the septum 38. In some designs, however, the septum 38 may include a shorter length than the distance between the notch 58 and the sharp distal tip 56, which may be desirable to reduce the size of the catheter adapter 34.In some designs, a length shorter than the distance between the notch 58 and the sharp distal tip 56 may also improve catheter fixation 36 and patient comfort while the catheter 33 resides within the vasculature. In some designs, a length shorter than the distance between the notch 58 and the sharp distal tip 56 may reduce the drag force of the introducer needle 42 within the catheter adapter 34. However, in some cases, the septum 38, which includes a length shorter than the distance between the notch 58 and the smaller, tapered distal tip 56, can prevent concurrent isolation of both the notch 58 and the tapered distal tip 56 of the introducer needle 42 within the septum 38 as the introducer needle 42 is withdrawn proximally. In some modalities, as illustrated in Figure 3, the housing 32 can function in conjunction with the septum 38 to avoid this problem. For example, the septum 38 in combination with the housing 32 can allow the introducer needle 42 to be retracted into the catheter adapter 34 while maintaining simultaneous isolation of both the notch 58 and the tapered distal tip 56, thereby preventing environmental contamination.Specifically, in some modalities, the notch 58 can be retracted into the housing 32 concurrently with the sharp distal tip 56 being retracted into the septum 38. In some embodiments, the sharp distal tip 56 of the introducer needle 42 can be retracted proximally into the cavity 78 of the housing 32. In some embodiments, the cavity 78 may include a safety mechanism to retain the sharp distal tip 56 of the introducer needle 42 within the housing 32 to protect against accidental needlestick injuries and environmental contamination from residual blood. In some embodiments, the safety mechanism may include the safety clip 52 disposed within the cavity 78 to keep the sharp distal tip 56 protected and to limit movement of the introducer needle 42. In some embodiments, the safety clip 52 and / or the barrier feature 54 may be sealed within the cavity 78 after installation. With reference to Figure 4, in some embodiments, the safety clamp 52 may be monolithically formed as a single unit. In some embodiments, the safety clamp 52 may be made of metal, plastic, a composite material, or another suitable material. In some modalities, actuation of the safety clamp 52 by withdrawing the introducer needle 42 proximal to the barrier feature 54 and / or the end portion 65, may occlude the distal end 46 of the housing 32 in such a way that the sharp distal tip 56 of the introducer needle 42 may be prevented from being reintroduced through it. In some modalities, in response to retraction of the introducer needle 42 in a proximal direction after the safety clamp 52 has been actuated, the introducer needle 42 and housing 32 can be withdrawn from the catheter adapter 34. In some modalities, the introducer needle 42 may include a needle feature 102, such as a protrusion, crimp, or other suitable needle feature on the longitudinal axis 60 of the introducer needle 42. Retraction of the introducer needle 42 in a proximal direction may cause the needle feature 102 to contact a proximal end 44 of the housing 32 or a proximal wall 103 of the safety clamp 52, through which the longitudinal axis 60 can extend.In some modalities, the proximal end of housing 32 may include an opening 101, and an outside diameter of the needle feature 102 may be larger than a diameter of the opening 101, which may prevent the introducer needle 42 from being withdrawn proximally through the opening 101. In some modalities, the proximal wall 103 of the safety clamp 52 may include an opening 105, and an outside diameter of the needle feature 102 may be larger than a diameter of the opening 105, which may prevent the introducer needle 42 from being withdrawn proximally through the opening 105. In some modalities, retraction of the introducer needle 42 may cause the needle feature 102 to contact or interfere with the opening 101 or the opening 105. In some modalities, the contact or interference may cause the retention features 96 to disengage from the securing features 98 and / or the housing 32 to be pulled out of a proximal end of the lumen 100 in response to retraction or withdrawal of the introducer needle 42 in the proximal direction. In some modalities, in response to retraction of the introducer needle 42 in the proximal direction, the resilient material that may form the distal end 46 of the housing 32 may deform, releasing the proximal end 48 from the septum 38. In some modalities, retraction of the housing 32 in the proximal direction may pull the distal end 46 of the housing 32 away from the proximal end 48 of the septum 38, withdrawing the housing 32 from the septum 38. With reference now to Figures 5A-5C, in some embodiments, the housing 32 may include more than one part, which may be coupled together, for example, through a joint. For example, as illustrated in Figures 5A and 5B, the housing 32 may include an upper portion 74 and a lower portion 72. In some embodiments, each of the upper and lower portions 74, 72 may have a shape and dimensions configured such that the upper portion 74 and the lower portion 72 can be coupled together to form the housing 32. In some embodiments, as illustrated in Figure 5A, the lower portion 72 may include an opening 108 formed by a rim. In some embodiments, the lower portion 72 may include a projection 104 or protrusion separate from the rim that forms the opening. In some embodiments, the projection 104 may be L-shaped.In some embodiments, the upper portion 74 may be configured to be received in the opening 108 and supported by the projection 104 of the lower portion 72. In some embodiments, the upper portion 74 and the lower portion 72 may be coupled together by means of an interference fit, an adhesive, a mechanical element such as a hinge, or by any other suitable method or device. In some embodiments, the upper portion 74 may be sealed to the lower portion 72 to make the housing 32 watertight. In some modalities, the proximal end 44 of the lower portion 72 of housing 32 may include an access point 66 through which the sharp distal tip 56 of the introducer needle 42 can enter and / or be withdrawn from housing 32. In some modalities, in response to the insertion of the introducer needle 42 through the proximal end 44 at the access point 66, the opening 105 may be formed. In some modalities, the access point 66 may include a visual indicator or mark that identifies a desired entry point for the sharp distal tip 56 of the introducer needle 42. In some modalities, the access point 66 may include a slit or other variation in the texture, shape, or color of the proximal end 44 of the lower portion 72 through which the sharp distal tip 56 can be inserted. In some modalities, the access point 66 may be located off-center relative to the proximal end 44 of the housing 32. In these and other modalities, the introducer needle 42 may extend through the cavity 78 along a line off-center with respect to the housing 32 to align with the catheter 36. In other modalities, the access point 66 and the introducer needle 42 may be centered relative to the proximal end 44 of the housing 32. In some modalities, the lower portion 72 may include one or more support elements 68, which may include a support channel 70 to support and retain the longitudinal axis 60 of the introducer needle 42. In some modalities, the support channel 70 may further direct the tapered distal tip 56 of the introducer needle 42 to and / or through an exit point at the distal end 46 of the housing 32. In some modalities, the position of the support channel 70 may be aligned with the catheter 36 such that the support channel 70 can guide the introducer needle 42 into the catheter 36. In some embodiments, the housing 32 may include a reinforcing rib 76, which can exert a downward force on the safety clamp 52. In some embodiments, the upper portion 74 may include the reinforcing rib 76. As illustrated in Figure 5C, in some embodiments, the reinforcing rib 76 may be angled. In some embodiments, the reinforcing rib 76 may push the barrier feature 54 of the safety clamp 52 against the longitudinal axis 60 of the introducer needle 42. In these and other embodiments, the upper portion 74 may be coupled to the lower portion 72 or ML / a / ZUZZ / U 14011 the upper portion 74 and the lower portion 72 can be formed monolithically as a single unit. In some embodiments, the cavity 78 may include a length and / or other dimensions sufficient to contain both the sharp distal tip 56 and the notch 58 of the introducer needle 42. In some embodiments, the cavity 78 may include a groove or cutting feature 62 to reduce friction between the cavity 78 and the introducer needle 42 when the introducer needle 42 is inserted through or withdrawn from the housing 32. In some embodiments, the cutting feature 62 may extend proximally from the support element 68, which may include a protrusion and / or a triangular shape. With reference now to Figures 6A-6C, in some embodiments, housing 32 may be formed monolithically as a single unit. As illustrated in Figure 6A, some embodiments may include housing 32 formed monolithically as a single unit to include cavity 78. In some embodiments, the safety clamp 52 may be secured within cavity 78. For example, the proximal wall 103 of the safety clamp 52 may be coupled to the proximal end 44 of housing 32 and / or the extended arm portion 64 may extend distally from the proximal end 44 of the housing 32. In some modalities, the elongated arm portion 64 may extend along an upper surface of the cavity 78 and / or near the reinforcing rib 76. In some modalities, the barrier feature 54 may extend in a downward direction from a distal end of the elongated arm portion 64. As illustrated in Figure 6B, in some modalities, the reinforcing rib 76 can be compressed in response to the introducer needle 42 extending through the housing 32 and positioned for insertion into the patient. As illustrated in Figure 6C, in some modalities, in response to the proximal retraction of the introducer needle 42, such that the barrier feature 54 moves downward and protects the sharp distal tip 56, the reinforcing rib 76 can expand and exert pressure on the elongated arm portion 64, which can facilitate the secure shielding of the sharp distal tip 56. With reference now to Figures 7A-7D, in some embodiments, the housing 32 may include a first resilient element 80 and a second resilient element 82 coupled to the first resilient element 80. In some embodiments, the first resilient element 80 may include a coupling element 90, and the second resilient element 82 may include another coupling element 91 coupled to the coupling element 90. In some embodiments, the coupling element 90 and the other coupling element 91 may couple the first and second resilient elements 80, 82 together such that the first and second resilient elements 80, 82 are angled to each other. For example, the first resilient element 80 may be angled at an angle of less than 180° to the second resilient element 82 to form a V-shape 114.In some modalities, the first and second resilient element 80, 82 may include silicone or any other suitable resilient material. In some embodiments, the coupling element 90 may include, for example, an opening 84 and a protrusion 86. In some embodiments, the other coupling element 91 may include another opening 85 configured to receive the protrusion 86 and another protrusion 87 configured to be inserted into the opening 84. In some modalities, the first and second resilient elements 80, 82 may each include a proximal and a distal end. In some modalities, the first resilient element 80 may include a first central hole 88, and the second resilient element 82 may include a second central hole 112. In some modalities, the first central hole 88 and the second central hole 112 align in response to the insertion of the introducer needle 42 through the first central hole 88 and the second central hole 112. In some modalities, the first and second central holes 88, 112 may have similar dimensions such that together they form a central passage 92 to receive the introducer needle 42. In some modalities, at least a portion of one or both of the first and second central holes 88, 112 may be formed by the introducer needle 42 extending through the first resilient element 80 and / or the second resilient elements 82. In some modalities, the introducer needle 42 may extend through at least a portion of the first resilient element 80 and / or the second resilient elements 82 to form the central passage 92. In some embodiments, the housing 32 may further include a first outer cover 116 and / or a second outer cover 117 to prevent the sharp distal tip 56 of the introducer needle 42 from entering or exiting the housing 32 at an undesignated point. In some embodiments, the first outer cover 116 and / or the second outer cover 117 may be rigid. The first outer cover 116 and / or the second outer cover 117 may include, for example, aluminum, metal, stainless steel, plastic, or other suitable material. In some embodiments, the first outer cover 116 may be coupled to at least a portion of an outer surface of the first resilient element 80 and / or the second outer cover 117 may be coupled to at least a portion of an outer surface of the second resilient elements 82.In some modalities, the first outer covering 116 may cover at least a portion of the proximal end of the first resilient element 80 and the second outer covering 117 may cover at least a portion of the distal end of the second resilient element 82. In some modalities, the first outer covering 116 and / or the second outer covering 117 may include an opening 120, which may be configured to receive the introducer needle 42 through it. With reference now to Figures 8A and 8B, in some modalities, a distal end 118 of the first resilient element 80 may be configured to contact or engage the septum 38 disposed within the lumen 100 of the catheter adapter 34. This may facilitate the distal extension of the introducer needle 42 through the housing 32 and the septum 38 and into the catheter 36. In some modalities, as illustrated in Figure 8A, in response to the introducer needle 42 extending through the central passage 92 within the septum 38, the angle or V-shape 114 between the first resilient element 80 and the second resilient element 82 may straighten such that the first resilient element 80 and the second resilient element 82 are aligned with the longitudinal axis 60 of the introducer needle 42. In some modalities, as illustrated in Figure 8B, in response to withdrawal From the introducer needle 42 of the septum 38, the V shape 114 can be formed. The formation of the V-shape 114 in this manner may cause the second resilient element 82 to pivot relative to the first resilient element 80 such that the sharp distal tip 56 of the introducer needle 42 is guided to a periphery or wall of the central passage 92. In some modalities, the sharp distal tip 56 may be secured within the resilient material of the first resilient element 80. In some modalities, the direction of the sharp distal tip 56 to the periphery or wall of the central passage 92 in response to the recovery of the V-shape 114 may also prevent further movement of the introducer needle 42. The formation of the V-shape 114 may therefore also secure the notch 58 of the introducer needle 42 within the central passage 92. In some modalities, a proximal wall of the second resilient element 82 or of the second outer covering 117 may include an opening, and an outside diameter of the needle feature 102 may be larger than a diameter of the opening, which may prevent the introducer needle 42 from being withdrawn proximally through the opening 101. All examples and conditional language used herein are for pedagogical purposes to assist the reader in understanding the invention and the concepts contributed by the inventor to further the art, and should be interpreted as not being limited to such examples and conditions specifically described. Although the embodiments of the present inventions have been described in detail, it should be understood that various changes, substitutions, and alterations may be made herein without departing from the spirit and scope of the invention. It is hereby stated that, as of this date, the best method known to the applicant for putting the aforementioned invention into practice is the one that is clear from the present description of the invention.

Claims

CLAIMS Having described the invention as above, the following claims are claimed as property:

1. A catheter system, characterized in that it comprises: a catheter assembly, comprising a catheter adapter and a catheter extending distally from the catheter adapter; a needle assembly coupled to the catheter assembly, the needle assembly comprising a needle hub and an introducer needle, wherein the needle hub is coupled to a proximal end of the catheter adapter and wherein a proximal end of the introducer needle is secured within the needle hub; and a housing retained within a lumen of the catheter adapter, the housing comprising: a distal end and a proximal end;a cavity disposed within the housing to contain a longitudinal axis of the introducer needle, wherein the introducer needle extends through the distal end of the housing, the cavity, and the proximal end of the housing; and a safety clamp located within the cavity, wherein the safety clamp comprises an elongated arm portion and a barrier feature angled with respect to the elongated arm portion, wherein the barrier feature extends from the elongated arm portion toward the introducer needle, wherein the introducer needle presses the barrier feature outward, away from a longitudinal axis of the introducer needle, wherein in response to proximal retraction of the introducer needle, the barrier feature is configured to move toward the longitudinal axis of the needle and protect the sharp distal tip.

2. The catheter system according to claim 1, characterized in that the housing is sealed.

3. The catheter system according to claim 1, characterized in that an outer surface of the housing comprises at least one retention feature configured to engage at least one securing feature disposed within the lumen.

4. The catheter system according to claim 1, characterized in that the distal end of the housing is configured to contact or couple to a septum disposed within the lumen. 5.- The catheter system according to claim 1, characterized in that the housing comprises a resilient material.

6. The catheter system according to claim 1, characterized in that the cavity comprises a reinforcing rib to exert a downward force on the safety clamp to drive the barrier feature against the longitudinal axis of the introducer needle.

7. The catheter system according to claim 1, characterized in that the cavity comprises a length sufficient to contain the sharp distal tip and a notch of the introducer needle.

8. The catheter system according to claim 1, characterized in that the cavity comprises a trim feature to reduce friction between the cavity and the introducer needle.

9. The catheter system according to claim 1, characterized in that the safety clamp is resilient.

10. The catheter system according to claim 1, characterized in that the sharp distal tip of the introducer needle is configured to form an orifice through at least one of the proximal and distal ends of the housing, so that the longitudinal axis can be extended through the cavity.

11. A catheter system, characterized in that it comprises: a catheter assembly comprising a catheter adapter and a catheter extending distally from the catheter adapter; a needle assembly coupled to the catheter assembly, the needle assembly comprising a needle hub and an introducer needle, wherein the needle hub is coupled to a proximal end of the catheter adapter and wherein a proximal end of the introducer needle is secured within the needle hub; and a housing retained within a lumen of the catheter adapter, comprising: a first resilient element, comprising a proximal end, a distal end, a first central hole, and a coupling element;a second resilient element proximal to the first resilient element, wherein the second resilient element comprises a proximal end, a distal end, a second central hole, and another coupling element, wherein the coupling element and the other coupling element are coupled to each other; wherein the first central hole and the second central hole form a central passage configured to receive a longitudinal shaft of the introducer needle through the same, wherein the first and second resilient elements are configured to form a V-shape in response to proximal retraction of the introducer needle proximal to a distal wall of the first resilient element.

12. The catheter system according to claim 11, characterized in that the housing further comprises a first outer cover coupled to an outer surface of the first resilient element and a second outer cover coupled to an outer surface of the second resilient element.

13. The catheter system according to claim 12, characterized in that the first outer covering and the second outer covering comprise an opening for receiving the introducer needle through it.

14. The catheter system according to claim 13, characterized in that the distal end of the first resilient element is configured to contact or couple to a septum disposed within the lumen.

15. The catheter system according to claim 14, characterized in that in response to the introducer needle extending through the central passage into the septum, the V shape straightens along the longitudinal axis.

16. The catheter system according to claim 15 characterized in that, in response to the withdrawal of the introducer needle from the septum, the first resilient element disengages from the septum to facilitate the removal of the catheter adapter housing.

17. The catheter system according to claim 15, characterized in that in response to the formation of the V shape, a sharp distal tip of the introducer needle comes into contact with a wall of the central passage.

18. The catheter system according to claim 17, characterized in that in response to the formation of the V shape, a notch in the introducer needle is secured within the central passage.

19. The catheter system according to claim 11, characterized in that at least one of the first central holes and the second central hole is formed by the introducer needle.

20. The catheter system according to claim 11, characterized in that the first coupling element comprises a projection and an opening, wherein the second coupling element comprises another projection and another opening.

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