Catheter system

Abstract

A closed IV catheter system extending in a distal-proximal direction along a central axis (A) is disclosed. The catheter system (10) comprises: a catheter hub (100) having: a tubular catheter (101) attached at its proximal end to a catheter hub body (102); and a catheter hub cavity (103) in fluid communication with the lumen of the tubular catheter (101); a tube connector (104) in fluid communication with the catheter hub cavity (103). A tube connector (104) extends laterally from the catheter hub body (102). The catheter system (10) also includes a septum (106) having a distal end (116) and a proximal end (126) and disposed inside the catheter hub cavity (103) proximal to the tube connector (104). The septum (106) comprises a pocket (107) extending in a distal-proximal direction towards the central axis (A) between a distal end (116) and a proximal end (126), and the distal end (116) of the septum (106) extends distally past a waist (109) disposed on an inner surface of the catheter hub cavity (103).

Description

Technical Field

[0001] The present invention relates to a closed IV catheter system. Furthermore, the present invention relates to a method for assembling the closed IV catheter system. Background Art

[0002] Catheters, particularly intravascular (IV) catheters, are used to regularly administer fluids and / or medications to patients. Fluid is supplied through the catheter via a lateral extension tube that is coupled to the catheter via an extension tube coupling that is present on and extends from the catheter hub body.

[0003] To protect caregivers and patients from infection caused by the exchange of bodily fluids (e.g., blood) when the needle is withdrawn through the catheter, a needle septum can be placed within the catheter to prevent blood or other bodily fluids from leaking. The septum also provides a barrier to prevent fluids and / or medications from leaking from the catheter hub.

[0004] However, when the septum is arranged on the proximal side of the laterally extending tube, air bubbles may form and accumulate in the region between the distal surface of the septum and the tube. Such air bubbles may then mix with the fluid being administered to the patient through the tube, which is undesirable.

[0005] Therefore, there is a clear need for an improved catheter device. Summary of the Invention

[0006] The present invention therefore seeks to mitigate, alleviate, eliminate, or overcome one or more of the aforementioned deficiencies and shortcomings in the art, individually or in any combination, by providing, according to a first aspect, a closed IV catheter system extending in a distal-proximal direction along a central axis. The catheter system comprises a catheter hub including: a tubular catheter attached at its proximal end to a catheter hub body; and a catheter hub cavity in fluid communication with the lumen of the tubular catheter. The catheter system also comprises: a tube connector in fluid communication with the catheter hub cavity, the tube connector extending laterally from the catheter hub body; and a septum having a distal end and a proximal end. The septum is disposed within the catheter hub cavity proximal to the tube connector and includes a recess between the distal and proximal ends. The recess extends distally through a waist disposed on the inner surface of the catheter hub cavity. This is advantageous because it prevents air bubbles from accumulating in the region between the distal surface of the septum and the inner surface of the catheter hub cavity. Air bubbles that could potentially form when fluid is administered through the tube connector could also flow into the patient's body.

[0007] In a second aspect, a method for assembling a closed IV catheter system is provided. The method includes inserting a needle through a septum having a distal end and a proximal end; and positioning the septum within a catheter hub cavity proximal to a tube connector. The septum includes a recess extending between the distal end and the proximal end, with the recess extending distally past a waist disposed on an inner surface of the catheter hub cavity. The needle extends through the catheter hub cavity and the catheter. This method is advantageous because it is simple and provides a closed IV catheter system that prevents the formation of air bubbles in the region between the distal end surface of the septum and the inner surface of the catheter hub cavity.

[0008] Further characteristics of the invention and its embodiments are set forth in the dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] These and other aspects, features and advantages of the present invention will become apparent from the following description of non-limiting embodiments of the present invention with reference to the accompanying drawings, in which:

[0010] Figure 1 is an isometric view of a closed IV catheter system according to one embodiment of the present invention;

[0011] Figure 2 Expressed Figure 1 A perspective view of a longitudinal section of a closed IV catheter system is shown;

[0012] Figure 3a Shows the view from above Figure 2 closed IV catheter system;

[0013] Figure 3b Expressed Figure 3a A closed IV catheter system, which has no septum;

[0014] Figures 4a-4c shows a septum to be deployed in a closed IV catheter system according to one embodiment of the present invention; and

[0015] Figure 5 An exploded view of a closed IV catheter system according to one embodiment of the present invention is shown. DETAILED DESCRIPTION

[0016] Embodiments of the present invention will be described in more detail below with reference to the accompanying drawings so that those skilled in the art can practice the invention. However, the present invention may be implemented in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. The embodiments do not limit the invention, which is limited only by the appended patent claims. Furthermore, the terms used in the detailed description of the specific embodiments shown in the accompanying drawings are not intended to limit the invention.

[0017] More specifically, the term "proximal" refers to the position or orientation of an item or component of an item that, during normal use of the closed IV catheter system disclosed herein, is closest to the user (i.e., clinician) and farthest from a patient receiving the closed IV catheter system.

[0018] Similarly, the term "distal" refers to the position or orientation of an item or component of an item that is closest to the patient and farthest from the clinician during normal use of the closed IV catheter systems disclosed herein.

[0019] The term "laterally" refers to a direction away from the central axis of the closed IV catheter system such that at least the vector component is perpendicular to the central axis of the closed IV catheter system, wherein the needle and catheter of the assembled closed IV catheter system coincide with the central axis of the closed IV catheter system.

[0020] The following will refer to Figures 1 to 5 Embodiments of the present invention are described.

[0021] according to Figure 1 , shows one embodiment of a catheter hub 100 of a closed IV catheter system 10. The closed IV catheter system 10 extends along a central axis A, which extends in a proximal-distal direction. The disclosed catheter system 10 is a closed system, i.e., in the system, the septum 106 (in Figure 2 、 3a , 4a-c and 5) are disposed in the catheter hub body 102, and fluid is extracted or introduced through a laterally extending tube (not shown).

[0022] like Figure 1 As shown, the catheter hub 100 includes a longitudinal tubular catheter 101 at the distal end. According to the above, the catheter 101 will be inserted into the patient's blood vessel. The proximal end of the catheter 101 is attached to the catheter hub body 102 so that the catheter 101 extends distally from the catheter hub body 102.

[0023] The tube connector 104 is provided from the catheter hub body 102. The tube connector 104 extends laterally from the catheter hub body 102. The tube connector 104 extends laterally and proximally from the catheter hub body 102 at a certain angle. The tube connector 104 is configured to connect with a tube (not shown) to allow infusion from the tube into the tube connector 104 and further into the catheter 101 to the patient. The tube connector 104 has a portion closest to the septum 106 (at Figure 2 and 3a ) and the distal end of the tube connector closest to the catheter 101.

[0024] A pair of wings 105 extend laterally from the catheter hub body 102. The wings 105 may have another shape that is a substantially flat shape configured to contact a surface of a patient (e.g., the upper surface of the patient's hand). The wings 105 are preferably made of a resilient material, such as rubber, silicone, or an elastomeric polymer. The tube connector 104 is disposed on top of the wings 105.

[0025] Prior to inserting the catheter 101 into the patient, a needle (not shown) is configured to extend through the septum 106, through the catheter hub lumen 103, and further into the catheter 101 such that the needle tip extends distally from the catheter 101. Once the needle is inserted intravenously into the patient, the needle is retracted through the closed IV catheter system 10, and the catheter 101 remains within the vein so that fluids, such as medications, can be introduced through tubing attached to the tubing connector 104.

[0026] Figure 2 shows an isometric view of a cross section of the catheter system 10, Figure 3a Expressed Figure 2 A cross-sectional view of the catheter system 10 as seen from above.

[0027] Catheter 101 (in Figure 1 The lumen of the catheter hub 102 is fluidically connected to the catheter hub cavity 103 arranged inside the catheter hub body 102.

[0028] The catheter hub body 102 is preferably manufactured by injection molding and is then made of a rigid plastic material suitable for injection molding and connection and interaction with other parts of the system. Such a suitable material is polycarbonate or a copolymer of polycarbonate and polyester.

[0029] Tube connector 104 has a lumen in fluid communication with hub cavity 103 so that a tube (not shown) can be connected to tube connector 104 to allow infusion from the tube into tube connector 104, further into hub cavity 103, to catheter 101, and ultimately into the patient's bloodstream. Tube connector 104 can, for example, be tubular. Suitable materials for the tube are polyurethane, polyvinyl chloride, or ethylene vinyl acetate. The tube is configured to be attached to an outer end 104a of tube connector 104, which has a wider width than the remainder closer to axis A.

[0030] The septum 106 is disposed in a proximal portion of the catheter hub cavity 103. The septum 106 is disposed proximal to the tube connector 104 and / or the tube. Thus, the catheter hub body 102 includes the catheter hub cavity 103 and surrounds the septum 106. The septum 106 prevents fluid present in the connector tube 104, the catheter 101, or the catheter hub cavity 103 from flowing proximally through the septum 106.

[0031] refer to Figure 2 、 3a 3b, the inner surface of the catheter hub cavity 103 includes a waist 109. The waist 109 may also be referred to as an annular step surface 109 or a circumferential step 109. Preferably, the waist 109 is circumferential, ie, annular.

[0032] like Figure 2 and 3a As shown, the septum 106 abuts against a waist 109. The septum 106 includes a dimple 107 that extends distally past the waist 109 disposed on the inner surface of the catheter hub lumen 103. The dimple 107 is in contact with the waist 109.

[0033] The waist 109 can be bent, such as Figure 2 、 3a 3b, but can also be formed into a more sharp step edge. Therefore, the waist 109 can be a sharp edge surface, a chamfered surface or a rounded edge surface. The stepped waist 109 can be circumferential, i.e., annular, such as Figure 2 、 3a 3 b , or may be only partially disposed on the inner surface of the distal end of the catheter hub cavity 103 .

[0034] like Figure 3a As shown, the width of the catheter hub lumen 103 is wider in the proximal region of the waist 109 than the width of the catheter hub lumen 103 distal to the waist 109. Thus, the waist 109 can be considered to be a transition from a wider portion of the catheter hub lumen 103 to a narrower portion of the catheter hub lumen 103.

[0035] Thus, a waist 109 exists at the interface between the wider portion of the catheter hub lumen 103 and the narrower portion of the catheter hub lumen 103. The waist 109 prevents the central portion 146 of the septum 106 from moving further distally within the catheter hub lumen 103 past the waist 109. Thus, the portion of the septum 106 proximal to the recess 107 cannot extend further distally past the waist 109 into the catheter hub lumen 103.

[0036] Figure 3b A catheter system 10 is shown that includes a catheter hub 100. The catheter hub 100 includes: wings 105; a catheter hub body 102 that includes a catheter hub cavity 103; and a tube connector 104. Figure 3b In FIG. 1 , the septum 106 is not shown so that the waist 109 disposed inside the catheter hub cavity 103 can be more clearly seen.

[0037] A detailed view of the diaphragm 106 is shown in FIG. Figures 4a-4c Indicated in. Figure 4a An isometric view of the diaphragm 106 is shown. Figure 4b and4c A cross-sectional view of the diaphragm 106 along the central axis A and perpendicular to the axis A are shown respectively.

[0038] The diaphragm 106 is preferably made of an elastic material, such as rubber or silicone. Figures 4a-4c As shown, the diaphragm 106 also extends along the central axis A. The diaphragm 106 has a distal end 116 and a proximal end 126. The diaphragm 106 has a recess 107. The diaphragm 106 has a central portion 146 that is wider in diameter than the distal end 116 and the proximal end 126. Figures 4a-4c As shown, the dimple 107 is circumferential. The dimple 107 is configured to extend distally past a waist 109 disposed on the inner surface of the catheter hub cavity 103, as shown in FIG. Figure 2 3. Thus, the dimple 107 abuts the waist 109 and extends further distally into the catheter hub cavity 103, while the central portion 146 of the septum 106 cannot move or extend past the waist 109.

[0039] Furthermore, the diaphragm 106 is provided with a diaphragm cavity 136 disposed in a central portion 146 of the diaphragm 106. The diaphragm cavity 136 extends from an outer surface of the diaphragm central portion 146 into the diaphragm 106 toward the central axis A and extends past the central axis A toward an opposing outer surface of the diaphragm 106. Thus, the diaphragm cavity 136 does not extend through the entire diaphragm 106.

[0040] exist Figure 4a -b, each end portion 116, 126 has a diameter narrower than the diameter of the diaphragm center portion 146. Therefore, Figure 4a The septum 106 shown in Figure 1-c includes a proximal recess 117 that is identical to the recess 107. Thus, either end 116, 126 of the septum 106 can be inserted first into the catheter hub body 102. This facilitates assembly of the catheter system 10. Additionally, having recesses 107, 117 on each side of the septum 106 facilitates manufacture of the septum 106, which can be manufactured by injection molding.

[0041] Distal end 116 has distal surface 110 and proximal end 126 has proximal surface 111. Alternatively, septum 106 includes only one recess 107, central portion 146 extends all the way to proximal surface 111, and only distal end 116 has a narrower diameter than central portion 146 (not shown).

[0042] The dimple 107 is configured to contact a waist 109 of the catheter hub cavity 103. More specifically, the dimple 107 is disposed against the waist 109.

[0043] Preferably, Figure 3aAs shown, the dimple 107 is shaped to match the waist 109, so that the shape of the circumferential dimple 107 corresponds to the convex shape of the waist 109. Therefore, the dimple 107 and the waist 109 are in mating contact with each other inside the catheter hub body 102. In other words, the circumferential step 109 is shaped to match the profile of the dimple 107 so that the dimple 107 and the circumferential step 109 can directly contact each other. Figure 3a As shown, the angle of the dimple 107 corresponds to the angle of the waist 109.

[0044] like Figure 3a As shown, the dimple 107 abuts the waist 109, such that the dimple 107 of the septum 106 extends distally beyond the waist 109. The dimple 107 of the septum 106 extends toward the catheter 101. Furthermore, the distal surface 110 of the septum 106 is substantially flush with the proximal end of the tube connector, i.e., aligned along the central axis A. The distal surface 110 is perpendicular relative to the longitudinal axis A.

[0045] The distal end surface 110 of the septum 106 is arranged substantially flush with the tube connector 104 (eg, Figure 3a 10 and the tube connector 104. This in turn prevents air bubbles from forming in the area between the septum distal surface 110 and the tube connector 104 from flowing further through the catheter hub lumen 103 into the catheter 101 and being administered to the patient.

[0046] Preferably, the distal surface 110 of the septum 106 extends as close as possible to the interface between the proximal end of the tube connector 104 and the catheter hub cavity 103. Preferably, the distal surface 110 is flush with the inner wall of the proximal end of the tube connector 104, ie, flush along the central axis A.

[0047] In one embodiment (not shown), the distal surface 110 of the septum 106 is angled. Such a septum 106 has a Figure 2 3 , and is provided with a distal surface 110 that is angled relative to the longitudinal axis A. The angle of the angled distal surface 110 can be set so that the angle between the longitudinal center axis A and the distal surface 110 is between 30 degrees and 50 degrees, for example, 45 degrees. Thus, the distal end 116 of the septum 106 is shaped as a frustum of a cylinder so that the distal surface 110 has an elliptical surface area. Preferably, the angled distal surface 110 is flush with the connector tube 104 at the lateral side adjacent to the connector tube 104 and extends distally into the catheter hub cavity 103.

[0048] The angle of the distal surface 110 can be the same angle as the angle between the connector tube 104 and the catheter hub body 102. More preferably, the angled distal surface 110 can begin at the proximal end of the connector tube 104 and extend distally at an angle through the connector tube 104. The angled distal surface 110 further reduces the risk of air being trapped or accumulated in the area between the catheter 104 and the septum 106 of the catheter hub cavity 103.

[0049] like Figure 2 and 3a As shown, the waist 109 prevents the septum 106 from moving further distally into the catheter hub cavity 103, past the waist 109. The waist 109 is arranged adjacent to the tube connector 104, proximal to the tube connector 104. A removably attached high pressure clamp 112 is arranged proximal to the proximal end surface 111 of the septum 106. The high pressure clamp 112 may be a high pressure clamp 112 as disclosed in the applicant's patent application WO2022 / 010396. Figure 5 The high pressure clamp 112 is further described. The high pressure clamp 112 prevents the septum 106 from moving proximally and holds the septum 106 in place within the catheter hub lumen 103 along with the waist 109 .

[0050] Figure 5 An exploded view of the catheter system 10 is shown. Figure 5 Wings 105 , catheter hub 100 including catheter hub body 102 and tube connector 104 , septum 106 , and high pressure clamp 112 are shown.

[0051] High voltage clamp 112 Figure 5 The high pressure clamp 112 is generally U-shaped and is made of a somewhat flexible material so that the upwardly extending legs of the U-shaped clamp 112 can bend inwardly toward the center of the U-shaped clamp 112. The pressure clamp legs each have a flange that together locks the diaphragm 106 and holds it in a position distal to the high pressure clamp 112.

[0052] Therefore, placing the high pressure clamp 112 in the catheter hub 100 has multiple functions. First, it locks the needle septum 106 within the catheter hub 100. In addition, placing the high pressure clamp 112 in the catheter hub 100 improves the assembly process of the catheter system 10, making it simpler. The assembly of the catheter system 10 will be explained in more detail below.

[0053] Preferably, the high voltage clamp 112 is made of a polymer material (eg, plastic) or a metal material.

[0054] To assemble the catheter system 10, a needle (not shown) is inserted through the septum 106 to form a subassembly, which is then inserted into the catheter hub body 102. When the subassembly including the needle and septum 106 is inserted into the catheter hub cavity 103, the subassembly is pushed distally into the catheter hub body 102 until the dimple 107 abuts the waist 109. Thus, the waist 109 prevents the septum 106 from further distal movement. The needle (not shown) will extend through the catheter hub cavity 103 and into and through the catheter 101 (at Figure 1 and 5 Insertion of the needle will push the recess 107 of the septum 106 slightly distal to the opening of the connector tube 104. However, when the needle is withdrawn during use, the septum 106 will slide proximally to the position indicated in FIG. Figure 2 and 3a Position shown.

[0055] Then, the high pressure clamp 112 is inserted into the catheter hub 100 from below. Figure 5 Thus, the upwardly extending legs of the high pressure clamp 112 will engage the upper aperture 102' of the catheter hub body 102 and hold the septum 106 in place.

[0056] According to another embodiment, to assemble the catheter system 10, the septum 106 is inserted into the catheter hub body 102. When the septum 106 is inserted into the catheter hub cavity 103, the dimple 107 will abut against the waist 109. Thus, the waist 109 blocks the septum 106.

[0057] Furthermore, the high pressure clamp 112 is inserted into the catheter hub 100 from below, as shown in FIG. Figure 5 Thus, the upwardly extending legs of the high pressure clamp 112 will engage the upper aperture 102' of the catheter hub body 102 and hold the septum 106 in place.

[0058] A needle (not shown) is then inserted into the catheter system 10 along axis A, through the septum 106 and through the catheter hub lumen 103, and into and through the catheter 101 ( Figure 1 ). Insertion of the needle will push the distal end 116 of the septum 106 slightly distal to the opening of the connector tube 104. However, when the needle is withdrawn during use, the septum 106 will slide proximally to a position such as Figure 2 and 3a Position shown.

[0059] Alternatively, the needle may be introduced before the high pressure clamp 112 is inserted into the catheter hub 100 .

[0060] Also, the diaphragm 106 is in its resting state (i.e., Figures 4a-4cThe widest diameter (shown) of the septum 106 is slightly wider than when the septum 106 is positioned within the catheter hub body 102. Due to its elasticity, the septum 106 will stretch slightly when pushed into the catheter hub cavity 103 (compared to its length in a resting state outside the catheter system 10). Therefore, the width of the catheter hub cavity 103 is slightly smaller than the diameter of the septum 106 in its resting state. This also facilitates stable placement of the septum 106 within the catheter hub cavity 103.

[0061] When the needle has been withdrawn from the catheter hub 100, the septum 106 will become sealed, marking out the hub cavity 103 from the surroundings in a proximal direction. To this end, the septum 106 is preferably manufactured from a suitable rubber material or silicone.

[0062] Preferably, the catheter hub body 102 is made of a polymeric material (e.g., a plastic material) that is more rigid than the elastomeric material forming the wings 105. Preferably, the catheter hub 100 and the wings 105 are integrally formed from different materials. During the manufacturing process, the catheter hub body 102 is formed by injection molding a first material (preferably a hard plastic material). Once the catheter hub body 102 is molded, the injection molding tool is rotated, and the wings 105 are injection molded onto the top of the catheter hub body 102 from a flexible material. The wings 105 and the catheter hub body 102 are formed from any of the materials described above.

[0063] In the claims, the term "comprises / comprising" does not exclude the presence of other elements or steps. Moreover, although listed separately, a plurality of means, elements or method steps may be implemented by, for example, a single unit or processor. In addition, although individual features may be included in different claims, these features may be advantageously combined, and the inclusion in different claims does not mean that a combination of features is not feasible and / or disadvantageous. In addition, singular references do not exclude a plurality. The terms "a", "an", "first", "second" etc. do not exclude a plurality. The reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

Claims

1. A closed IV catheter system extending in a distal-proximal direction along a central axis (A), wherein: The closed IV catheter system (10) comprises: - a catheter hub (100) comprising: a tubular catheter (101) attached at its proximal end to a catheter hub body (102); and a catheter hub cavity (103) in fluid communication with the lumen of the tubular catheter (101); - a tube connector (104) in fluid communication with the catheter hub cavity (103), the tube connector (104) extending laterally from the catheter hub body (102); and a septum (106) having a distal end (116) and a proximal end (126) and arranged inside the catheter hub cavity (103) proximal to the tube connector (104), Therein, the septum (106) includes a dimple (107) between a distal end (116) and a proximal end (126), the dimple (107) extending distally past a waist (109) disposed on the inner surface of the catheter hub lumen (103).

2. The closed IV catheter system of claim 1 , wherein: The dimple (107) is in contact with the waist (109).

3. The closed IV catheter system of claim 2, wherein: The shape of the dimple (107) matches the corresponding shape of the waist (109).

4. The closed IV catheter system according to any one of claims 1 to 3, wherein: The waist (109) is arranged proximally of the tube connector (104).

5. The closed IV catheter system according to any one of claims 1 to 4, wherein: The distal surface (110) of the septum (106) is flush with the proximal end of the tube connector (104).

6. The closed IV catheter system according to any one of claims 1 to 4, wherein: The distal surface (110) of the diaphragm (106) is angled relative to the central axis (A).

7. A closed IV catheter system according to any preceding claim, wherein: A waist (109) exists as an interface between a wider proximal portion of the catheter hub lumen (103) and a narrower distal portion of the catheter hub lumen (103).

8. A closed IV catheter system according to any preceding claim, wherein: The diameter of the dimple (107) is wider than the diameter of the distal end (116) of the septum (106).

9. A closed IV catheter system according to any preceding claim, wherein: The waist (109) is annular.

10. A closed IV catheter system according to any preceding claim, wherein: The waist (109) is a rounded or chamfered waist (109).

11. A closed IV catheter system according to any preceding claim, wherein: The diaphragm (106) includes another dimple (117) disposed at a proximal end (126) of the diaphragm (106).

12. A closed IV catheter system according to any preceding claim, wherein: The diaphragm (106) also includes a diaphragm cavity (136) extending laterally from an outer surface of the diaphragm (106) toward and through the central axis (A).

13. A closed IV catheter system according to any preceding claim, wherein: The diaphragm (106) is made of an elastomer, such as silicone or rubber.

14. A closed IV catheter system according to any preceding claim, wherein: The diaphragm (106) is formed as a single piece.

15. A method for assembling a closed IV catheter system according to any one of claims 1 to 14, wherein: The method comprises: - inserting a needle through a septum (106), said septum (106) having a distal end (116) and a proximal end (126); - Arranging a septum (106) inside the catheter hub cavity (103) proximal to the tube connector (104), wherein the septum (106) includes a recess (107) extending between a distal end (116) and a proximal end (126), the recess (107) extending distally through a waist (109) arranged on the inner surface of the catheter hub cavity (103), and the needle extending through the catheter hub cavity (103) and the catheter (101).

16. The method according to claim 15, wherein: During the step of placing the septum (106) inside the catheter hub cavity (103), the needle moves the septum (106) distally past the proximal end of the tube connector (104).

17. The method according to claim 15 or 16, wherein: The method also includes inserting a high pressure clamp (112) into the catheter hub (100) proximal to the septum (106) such that the high pressure clamp (112) prevents the septum (106) from moving proximally past the high pressure clamp (112).

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