EXTENSION PIPE CLAMP THAT PROVIDES A POSITIVE DISPLACEMENT

Abstract

An extension assembly may include a clamp, which may include a housing and an actuator. The actuator may be movable between a raised and a lowered position relative to the housing. The actuator may include a protrusion profile. The extension assembly may include an extension tube, which can be placed within the housing. The extension tube may include a loop. In response to the movement of the actuator between the raised and lowered positions relative to the housing, the protrusion profile can progressively clamp the extension tube along the loop. The loop can facilitate an increased volume of fluid flowing distally into a catheter in response to the clamp's actuation.

Description

EXTENSION TUBE CLAMP PROVIDING POSITIVE DISPLACEMENT Background of the Invention Catheters are commonly used for a variety of infusion therapies. For example, catheters can be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters can also be used to draw blood from a patient. A common type of catheter is an over-the-needle peripheral intravenous catheter (PIVC). As its name implies, the over-the-needle PIVC can be mounted over an introducer needle that has a pointed distal tip. The pointed distal tip can be used to puncture the patient's skin and vasculature. Insertion of the PIVC into the vasculature can follow the puncture of the vasculature by the needle. The needle and PIVC are generally introduced at a shallow angle through the skin into the patient's vasculature with a bevel of the needle facing away from the patient's skin. Once placement of the needle within the vasculature has been confirmed, the clinician can temporarily occlude or obstruct flow into the vasculature and withdraw the needle, leaving the PIVC in place for future blood draw. Ref. 325587 blood and / or liquid infusion. A needleless connector can be used to connect the PIVC to a medical device for fluid administration or blood withdrawal. The medical device can include a transfusion bag, syringe, or the like. Currently, many needleless connectors are subject to backflow, meaning they draw blood and fluid from the vasculature after the medical device is disconnected from the needleless connector. This connector-driven backflow is undesirable due to the increased potential for reduced PIVC residence time, which can result from clotting and occlusion within the PIVC. The systems and methods described herein can mitigate and / or overcome these drawbacks. The subject matter claimed herein is not limited to embodiments that address any disadvantages or operate only in environments such as those described above. Instead, this background is provided merely to illustrate an exemplary technology area where some of the implementations described herein may be practiced. Brief Description of the Invention In some embodiments, an extension assembly may include a bracket, which may include a housing and an actuator. In some embodiments, the actuator may be movable between a raised position and a lowered position relative to the housing. In some embodiments, the actuator may include a protrusion profile. In some embodiments, the extension assembly may include an extension tube, which may be positioned within the housing. In some embodiments, the extension tube may include a loop. In some embodiments, in response to movement of the actuator between the raised and lowered positions relative to the housing, the protrusion profile may progressively grip the extension tube along the loop. In some embodiments, the loop may facilitate an increased volume of fluid flowing distally toward a catheter in response to movement of the actuator to the lowered position. In some embodiments, in response to movement of the actuator between the raised position and the lowered position relative to the housing, the protrusion profile may contact a distal portion of the loop before contacting a proximal portion of the loop. In some embodiments, the protrusion profile may be configured to force fluid positioned within the loop distally in response to movement of the actuator from the raised position to the lowered position. In some embodiments, the housing may include one or more projections. In some embodiments, the actuator may include one or more slots. In some embodiments, the projections may be positioned within the slots to orient the actuator within the housing. In some embodiments, the projections and slots may prevent the actuator from rotating relative to the housing. In some embodiments, the actuator may include a head, which may be positioned outside the housing. In some embodiments, the head may contact an external surface of the housing in response to movement of the actuator to the collapsed position. In some embodiments, the actuator head may be positioned proximate an actuator body. In some embodiments, the diameter of a head may be larger than a diameter of the body. In some embodiments, the body may include the protrusion profile. In some embodiments, the housing may include a distal opening and a proximal opening. In some embodiments, the extension tube may extend through the distal opening and the proximal opening. In some embodiments, the loop may be positioned between the distal opening and the proximal opening. In some embodiments, an interior of the housing may include one or more support elements, which may be configured to contact the extension tube to support the extension tube and maintain the loop in a loop configuration. In some embodiments, the extension assembly may include a needleless connector coupled to the extension tube. In some embodiments, a catheter system may include the extension assembly and a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter and a catheter extending distally from the catheter adapter. In some embodiments, the extension tube may be coupled to the catheter adapter. In some embodiments, a method for gripping the extension tube may include placing a first finger of a user's hand on the actuator. In some embodiments, the first finger of the user's hand may include a thumb. In some embodiments, the method may include placing a second finger and a third finger of the user's hand on a side of the housing opposite the actuator and the first finger. In some embodiments, the method may include pushing down the actuator with the first finger to move the actuator to the collapsed position. In some embodiments, in response to the first finger pushing down the actuator, the protrusion profile may progressively grip the extension tube along the loop. The object and advantages of the embodiments will be realized and achieved at least by the elements, features, and combinations particularly pointed out in the claims. It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as claimed. Brief Description of the Figures Example modalities will be described and explained with additional specificity and detail through the use of the attached figures in which: Figure 1A is a side view of a prior art clamp, illustrating the prior art clamp in an unactuated position, in accordance with some embodiments; Figure IB is another side view of the prior art clamp of Figure 1A, illustrating the prior art clamp in an actuated position, according to some embodiments; Figure 2 is a top perspective view of an example catheter system, in accordance with some embodiments; Figure 3A is a top perspective view of an example clamp of the catheter system of Figure 2, illustrating an example actuator of the clamp in a raised position, according to some embodiments; Figure 3B is a top perspective view of the bracket of Figure 3A, illustrating the actuator in a collapsed position, according to some embodiments; Figure 4A is a side view of the clamp actuator of Figure 3A, according to some embodiments; Figure 4B is an opposite side view of the clamp actuator of Figure 3A, according to some embodiments; Figure 5A is an enlarged view of the clamp of Figure 3A, illustrating the actuator in the raised position, according to some embodiments; Figure 5B is a top view of the bracket of Figure 3A, illustrating the actuator in the collapsed position and an example head of the actuator removed for illustrative purposes, in accordance with some embodiments; Figure 6A is a partial sectional view of the clamp of Figure 3A, illustrating the actuator in the raised position, according to some embodiments; Figure 6B is another partial sectional view of the clamp of Figure 3A, illustrating the clamp in a partially lowered position, according to some embodiments; Figure 6C is another partial sectional view of the clamp of Figure 3A, illustrating the clamp in the collapsed position, according to some embodiments; Figure 6D is another partial sectional view of the clamp of Figure 3A, illustrating the clamp in the collapsed position, according to some embodiments; and Figure 7 is a top perspective view of an example extension assembly including the clamp of Figure 3A, according to some embodiments. Detailed Description of the Invention Referring now to Figures 1A-1B, a prior art clamp 10 is illustrated. An extension tube 12 may extend from a PIVC (not illustrated in Figures 1A-1B) and through the prior art clamp 10. The extension tube 12 may be connected to and proximal to the PIVC. The prior art clamp 10 attempts to overcome connector-driven reflux by distally displacing fluid along a predetermined length of the extension tube 12 during clamping of the extension tube 12. In further detail, in response to the clinician actuating the prior art clamp 10, the prior art clamp 10 acts to squeeze fluid out of the extension tube 12 in the vicinity of the prior art clamp 10, resulting in some positive clamp-driven displacement or net positive outflow of fluid from the PIVC.However, the clamp-driven positive displacement can be relatively small. Referring to Figure 2, an exemplary catheter system 14 is illustrated, in accordance with some embodiments. In some embodiments, the catheter system 14 may include a catheter assembly 16. In some embodiments, the catheter assembly 16 may include a catheter adapter 18 and a catheter 20 extending distally from the catheter adapter 18. In some embodiments, the catheter adapter 18 may include a side port 22 in fluid communication with the lumen of the catheter adapter 18. In some embodiments, the catheter adapter 18 may include a proximal end 23, a distal end 24, and a lumen extending therebetween. In some embodiments, the catheter 20 may include a PIVC. In some embodiments, the catheter assembly 16 may be removably coupled to a needle assembly, which may include a needle hub 26 and an introducer needle 28. In some embodiments, the introducer needle 28 may include a pointed distal tip 30. In some embodiments, a proximal end of the introducer needle 28 may be secured within the needle hub 26. In some embodiments, the introducer needle 28 may extend through the catheter 20 when the catheter assembly 16 is in an insertion position ready for insertion into a patient's vasculature, as illustrated, for example, in FIG.In some embodiments, in response to the introducer needle 28 being inserted into the patient's vasculature, blood return may flow through the pointed distal tip 30 of the introducer needle 28 and may be visible to a clinician between the introducer needle 28 and the catheter 20 and / or at another location within the catheter assembly 16. In some embodiments, in response to confirmation by blood return that the catheter 20 is positioned within the patient's vasculature, the needle assembly may be removed from the catheter assembly 16. In some embodiments, when the needle assembly is coupled to the catheter assembly 16, as illustrated, for example, in FIG. 2 , the introducer needle 28 of the needle assembly may extend through a septum positioned within the lumen of the catheter adapter 18. In some embodiments, the catheter system 14 may include an extension assembly 32, which may include an extension tube 34 and a clamp 36. In some embodiments, a distal end of the extension tube 34 may be integrated with the catheter adapter 18, as illustrated, for example, in Figure 2. For example, the extension tube 34 may be integrated into the side hole 24 of the catheter adapter 18. In some embodiments, the extension tube 34 may be removably coupled to the catheter adapter 18, as illustrated, for example, in Figure 7. In some embodiments, the clamp 36 may selectively close the extension tube 16 to prevent blood or other fluid from flowing through the extension tube 16. In some embodiments, the extension assembly 32 may include an adapter 38 coupled to a proximal end of the extension tube 34. In some embodiments, the adapter 38 may include a Y-adapter or other suitable connector. In some embodiments, a needleless connector 40 may be coupled to the adapter 38. In some embodiments, the adapter 38 and / or the needleless connector 40 may be used to connect the catheter 20 to a medical device for fluid administration or blood withdrawal. The medical device may include a transfusion bag, syringe, or any other suitable medical device. In some cases, the needleless connector 40 may be subject to reflux, meaning that the needleless connector 40 may draw blood and fluid from the vasculature into the catheter 20 after disconnection of the medical device from the needleless connector 40.This connector-driven reflux may not be desirable due to the increased potential for reduced catheter dwell times, which can result from clotting and occlusion within the catheter system 14. In some embodiments, the clamp 36 may facilitate positive displacement or net positive outflow of fluid from the PIVC. In some embodiments, in response to actuation of the clamp 36, fluid may be pushed out of the clamp 36 and into the catheter assembly 16, which may be connected to the extension tube 34 and positioned distal to the clamp 36. Fluid pushed out of the clamp 36 may be pushed into the catheter 20 and toward the patient. In some embodiments, the clamp 36 may include a housing 42 and an actuator 44. In some embodiments, the housing 42 may be constructed of multiple pieces, which may be coupled together, or the housing 42 may be formed monolithically as a single unit. Similarly, in some embodiments, the actuator 44 may be constructed of multiple pieces, which may be coupled together, or the actuator 44 may be formed monolithically as a single unit. It is understood that the size, shape, and configuration of the housing 42 and / or the actuator 44 may vary. Referring now to Figures 3A-3B, in some embodiments, the actuator 44 may be movable between a raised position and a collapsed position relative to the housing 42. The raised position is illustrated in Figure 3A, according to some embodiments. The collapsed position is illustrated in Figure 3B, according to some embodiments. In some embodiments, the clinician may move the actuator 44 to the collapsed position to actuate the clamp 36. In some embodiments, the actuator 44 may include a head 45, which may be positioned outside of the housing 42. In some embodiments, the head 45 may contact an external surface of the housing 42 when the actuator 44 is in the collapsed position. In some embodiments, the head 45 may not contact the external surface of the housing 42 when the actuator 44 is in the collapsed position. In some embodiments, a method of gripping the extension tube 34 may include placing a first finger of a user's hand on the actuator 44, as illustrated, for example, in Figures 3A-3B. In some embodiments, the first finger of the user's hand may include a thumb. In some embodiments, the method may include placing a second finger and a third finger of the user's hand on a side of the housing 42 opposite the actuator 44 and the first finger, as illustrated, for example, in Figures 3A-3B. In some embodiments, the method may include pinching the clamp to lower the actuator 44 and move the actuator 44 to the collapsed position. In some embodiments, in response to the first finger being collapsed, the protrusion profile may progressively grip the extension tube 34 along the loop. 4A-4B , in some embodiments, actuator 44 may include a protrusion profile 46. In some embodiments, head 45 of actuator 44 may be positioned proximate a body 58 of actuator 44. In some embodiments, a diameter of head 45 may be larger than a diameter of body 58. In some embodiments, body 58 may include protrusion profile 46. In some embodiments, protrusion profile 46 may include one or more flanges 47. For example, protrusion profile 46 may include a first flange 47a and a second flange 47b (which may be referred to herein as flanges 47). In some embodiments, the one or more ridges 47 may form a spiral or corkscrew shape on the body 58. In some embodiments, the protrusion profile 46 may include a continuous ridge 47, which may form the spiral or corkscrew shape on the body 58. In some embodiments, the coil may include a curve that rotates about an axis at a constant distance therefrom as it moves parallel to the axis. In some embodiments, the curve may rotate about the axis at a constant angle such that the coil pitch, or the height of the coil over one complete revolution of the coil, is constant. In some embodiments, the curve may rotate about the axis at a variable angle such that the coil pitch is variable. In some embodiments, the coil curve may be mathematically optimized based on the characteristics of a loop of the extension tube 34, such as a loop pitch. Referring now to Figure 5A-5B, in some embodiments, the extension tube 34 of the extension assembly 32 may include the loop 48. In some embodiments, in response to movement of the actuator 44 between the raised position and the lowered position relative to the housing 42, the protrusion profile 46 may progressively grip the extension tube 34 along the loop 48. In some embodiments, the loop 48 may facilitate an increased volume of fluid flowing distally from the clamp 36 into the catheter 20 in response to actuation of the clamp 36. In some embodiments, in response to movement of the actuator 44 between the raised position and the collapsed position relative to the housing 42, the protrusion profile 46 may contact a distal portion 50 of the loop 48 prior to contacting a proximal portion 52 of the loop 48. In some embodiments, an overlapping portion 49 of the loop 48 may be positioned between the distal portion 50 and the proximal portion 52. In some embodiments, the protrusion profile 46 may be configured to force fluid positioned within the loop 48 distally in response to movement of the actuator 44 from the raised position to the collapsed position. In some embodiments, the first ridge 47a may be spaced away from the second ridge 47b to form a gap 51 that may be aligned with the overlapping portion 49. In some embodiments, housing 42 may include one or more projections 54. In some embodiments, actuator 44 may include one or more slots 56. In some embodiments, projections 54 may be positioned within slots 56 to orient actuator 44 within housing 42. In some embodiments, projections 54 and slots 56 may prevent actuator 44 from rotating relative to housing 42. In some embodiments, housing 42 may not include projections 54 and / or actuator 44 may not include slots 56. In these and other embodiments, first flange 47a and second flange 47b may be connected or continuous. In some embodiments, housing 42 may include a distal opening 60 and / or a proximal opening 62. In some embodiments, extension tube 34 may extend through distal opening 60 and / or proximal opening 62. In some embodiments, loop 48 may be positioned between distal opening 60 and proximal opening 62. 6A-6D, in some embodiments, an interior of housing 42 may include one or more support members 64, which may be configured to contact extension tube 34 to support extension tube 34 and maintain loop 48 in a loop configuration. In some embodiments, support members 64 may include slots and / or protrusions. Figure 6A is a partial cutaway view of the clamp 36, illustrating the actuator 44 in the raised position, according to some embodiments. In some embodiments, when the actuator 44 is in the raised position, the one or more ridges 47 may not contact and / or pinch the extension tube 34. In some embodiments, when the actuator 44 is in the raised position, the one or more ridges 47 may not contact and / or grip the loop 48. In some embodiments, when the actuator 44 is in the raised position, the one or more ridges 47 may not contact and / or grip the distal portion 50 and the proximal portion 52. In some embodiments, in response to a portion of the extension tube 34 being clamped or pinched, fluid may be prevented from flowing through the portion. Figure 6B is another partial sectional view of the clamp 36, illustrating the clamp 36 in a partially lowered position, according to some embodiments. In some embodiments, when the actuator 44 is in the raised position, one or more of the ridges 47 may grip the distal portion 50 but not the proximal portion 52. Figure 6C is another partial sectional view of the clamp 36, illustrating the clamp in the folded down position, according to some embodiments. In some embodiments, when the clamp 36 is in the folded down position, both the distal portion 50 and the proximal portion 52 may be gripped by the one or more ridges 47. Accordingly, Figures 6A-6C illustrate how the protrusion profile 46 may progressively grip the extension tube 34 along the loop 48, according to some embodiments. Referring now to Figure 6D, another partial cutaway view of the clamp 36 is illustrated in the collapsed position, in accordance with some embodiments. In some embodiments, in response to the actuator 44 moving from the raised position to the collapsed position, a contact area between the flanges 47 and the extension tube 34 may be rotated about a circumference of the actuator 44. In these embodiments, in response to the actuator 44 moving from the raised position to the collapsed position, the contact area between the flanges 47 and the extension tube 34 may not increase in size, which may reduce an input force necessary to close the clamp 36. In these and other embodiments, as illustrated in Figure 6D, in response to the actuator 44 moving from the raised position to the folded position, a portion of the one or more flanges 47, such as a portion of the second flange 47b, may move beyond the distal portion 50 and no longer contact and / or grip the distal portion 50. In some embodiments, a portion of the one or more flanges 47 in contact with the extension tube 34 may move beyond the extension tube 34 to no longer contact and / or grip the extension tube 34 in response to movement of the actuator 44 from the raised position to the folded position. In some embodiments, the one or more flanges 47 may spiral to progressively grip and / or move beyond the extension tube 34. Figure 7 is a top perspective view of an exemplary extension assembly 66 including clamp 36, according to some embodiments. In some embodiments, a distal end 68 of extension tube 34 may be coupled to side port 22 (illustrated, for example, in Figure 2) by a connector 70. In some embodiments, connector 70 may include a luer adapter, such as, for example, a slip or thread male or female luer adapter. In some embodiments, connector 70 may include a non-luer adapter. In some embodiments, distal end 68 of extension tube 34 may be integral with connector 70. All examples and conditional language mentioned herein are intended for pedagogical purposes to aid the reader in understanding the invention and the concepts contributed by the inventor to advance the art, and are to be construed as not limiting these specifically mentioned examples and conditions. Although 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 noted that with respect to this date, the best method known to the applicant for putting the present invention into practice is the one that is clear from the present description of the invention.

Claims

1. An extension assembly, characterized in that it comprises: a clamp, comprising: a housing; and an actuator movable between a raised position and a lowered position with respect to the housing, wherein the actuator comprises a protrusion profile; and an extension tube positioned within the housing, wherein the extension tube comprises a loop, wherein in response to the movement of the actuator between the raised position and the lowered position with respect to the housing, the protrusion profile progressively clamps the extension tube along the loop.

2. The extension assembly according to claim 1, characterized in that the protrusion profile is configured to force the fluid placed within the loop distally in response to the movement of the actuator from the raised position to the lowered position.

3. The extension assembly according to claim 1, characterized in that in response to the movement of the actuator between the raised position and the lowered position with respect to the housing, the protrusion profile comes into contact with a distal portion of the loop before coming into contact with a proximal portion of the loop.

4. The extension assembly according to claim 1, characterized in that the housing comprises a projection, wherein the actuator comprises a groove, wherein the projection is placed within the groove to orient the actuator within the housing.

5. The extension assembly according to claim 1, characterized in that the actuator comprises a head positioned outside the housing, wherein the head comes into contact with an external surface of the housing in response to the movement of the actuator to the folded position.

6. The extension assembly according to claim 5, characterized in that the actuator head is positioned close to an actuator body, wherein a diameter of the head is greater than a diameter of the body, and wherein the protrusion profile is positioned on the body.

7. The extension assembly according to claim 1, characterized in that the housing comprises a distal opening and a proximal opening, wherein the extension tube extends through the distal opening and the proximal opening, wherein the loop is placed within the housing between the distal opening and the proximal opening.

8. The mounting clamp according to claim 1, characterized in that an interior of the housing comprises a support element configured to contact the extension tube to support the extension tube and maintain the loop in a loop configuration.

9. The extension assembly according to claim 1, characterized in that it further comprises a needleless connector coupled to the extension tube.

10. 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 clamp, comprising: a housing; an actuator movable between a raised position and a lowered position with respect to the housing, wherein the actuator comprises a protrusion profile; and an extension tube coupled to the catheter adapter, wherein the extension tube comprises a loop, wherein in response to the movement of the actuator between the raised position and the lowered position with respect to the housing, the protrusion profile progressively clamps the extension tube along the loop.

11. The extension assembly according to claim 10, characterized in that the protrusion profile is configured to force the fluid placed within the loop distally in response to the movement of the actuator from the raised position to the lowered position.

12. The extension assembly according to claim 10, characterized in that in response to the movement of the actuator between the raised position and the lowered position with respect to the housing, the protrusion profile comes into contact with a distal portion of the loop before coming into contact with a proximal portion of the loop.

13. The extension assembly according to claim 10, characterized in that the housing comprises a projection, wherein the actuator comprises a groove, wherein the projection is placed within the groove to orient the actuator within the housing.

14. The extension assembly according to claim 10, characterized in that the actuator comprises a head positioned outside the housing, wherein the head comes into contact with an external surface of the housing in response to the movement of the actuator to the folded position.

15. The extension assembly according to claim 14, characterized in that the actuator head is positioned close to an actuator body, wherein a diameter of the head is greater than a diameter of the body, and wherein the protrusion profile is positioned on the body.

16. The extension assembly according to claim 10, characterized in that the housing comprises a distal opening and a proximal opening, wherein the extension tube extends through the distal opening and the proximal opening, wherein the loop is placed within the housing between the distal opening and the proximal opening.

17. The mounting clamp according to claim 1, characterized in that an interior of the housing comprises a support element configured to contact the extension tube to support the extension tube and maintain the loop in a loop configuration.

18. A method for holding an extension tube characterized in that it comprises: placing a first finger of a user's hand on an actuator of a clamp of an extension assembly, wherein the first finger includes a thumb, wherein the extension assembly comprises: a clamp, comprising: a housing; and the actuator movable between a raised position and a lowered position with respect to the housing, wherein the actuator comprises a protrusion profile; an extension tube including a loop; placing a third and a fourth finger of the user's hand on one side of a housing opposite the actuator; and lowering the actuator with the first finger to move the actuator to a lowered position with respect to the housing, wherein in response to lowering the actuator with the first finger, the protrusion profile progressively clamps the extension tube along the loop.

19. The method according to claim 18, characterized in that the protrusion profile is configured to force the fluid placed within the loop distally in response to the actuator being pulled down.

20. The method according to claim 18, characterized in that in response to the movement of the actuator between the raised position and the lowered position with respect to the housing, the protrusion profile comes into contact with a distal portion of the loop before coming into contact with a proximal portion of the loop.

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