Subcutaneous implantable port

Abstract

To provide a subcutaneously implanting-type port having a novel structure capable of stably maintaining a state in which a catheter is connected to a connection port.SOLUTION: A subcutaneously implanting-type port 10 includes a lumen 24 for storing drug solution which is blocked by an elastic lid 18, and has a housing 16 provided with a connection port 20 which communicates with the lumen 24 and is inserted and connected to a catheter 74. The subcutaneously implanting-type port 10 has a sleeve-like connection cap 14 which is externally inserted to the catheter 74 and holds a connection-side end of the catheter 74 between the connection cap and the connection port 20 in a radial direction. The connection cap 14 has a locking section 90 capable of locking the housing 16.SELECTED DRAWING: Figure 6

Description

Technical Field

[0001] The present invention relates to a subcutaneous implantable port that is implanted under the skin of a patient in the medical field and is used for injecting a chemical solution or the like into the body, and can prevent the catheter from coming off.

Background Art

[0002] Conventionally, when performing a treatment for repeatedly injecting a chemical solution or the like into the body over a long period of time, in order to reduce the burden caused by repeated punctures to the human body, it has been considered to implant a port for injecting a chemical solution under the skin of the patient.

[0003] Such a subcutaneous implantable port for injecting a chemical solution has a structure in which, for example, like the subcutaneous implantable port disclosed in Japanese Patent Application Laid-Open No. 2012-070986 (Patent Document 1), the opening of the housing is closed by an elastic lid body and a lumen for storing a chemical solution is formed. Then, the chemical solution injected into the lumen by a needle that penetrates the skin and punctures the elastic lid body is guided from a connection port that constitutes a flow path for discharging the chemical solution provided on the outer peripheral portion of the housing, through a catheter, and injected into a body lumen such as a blood vessel.

[0004] By the way, in a subcutaneous implantable port having a conventional structure, the catheter is fitted and connected to the connection port in an extrapolated state. The catheter is, for example, cut to an appropriate length according to the patient's physique by a doctor and then attached to the connection port. At that time, there may be a case where the catheter removed from the connection port is attached to the connection port again after the length is adjusted. Therefore, it is desirable that the catheter be detachably attached to the connection port without being adhered or the like.

Prior Art Documents

Patent Documents

[0005] [[ID=3~0]]

Patent Document 1

Summary of the Invention

[0006] Subcutaneous implantable ports are devices that are left in place for extended periods. As a result of prolonged placement, the tip or middle portion of the catheter may become fixed to the body. If the area where the subcutaneous implantable port is implanted is moved vigorously in this state, there is a risk that the catheter may become dislodged from the subcutaneous implantable port.

[0007] The problem to be solved by the present invention is to provide a novel subcutaneous implantable port structure that can stably maintain a connection state to the catheter's connection port. [Means for solving the problem]

[0008] The following describes preferred embodiments for understanding the present invention. However, each embodiment described below is illustrative and can be combined with others as appropriate. Furthermore, the multiple components described in each embodiment can be recognized and adopted as independently as possible, and can be combined with any component described in another embodiment as appropriate. Thus, the present invention is not limited to the embodiments described below, and various other embodiments can be realized.

[0009] A first aspect of the present invention is a subcutaneous implantable port having a housing that includes a lumen for storing a drug solution, which is sealed with an elastic lid, and a connection port that communicates with the lumen and is inserted into a catheter, wherein the housing is provided with a pair of locking projections on both sides in the circumferential direction, excluding portions that face each other in the vertical direction on either side of the connection port, and the pair of locking projections have a flexible portion formed at the base end portion in the protruding direction which is thinner than the tip end portion, and the housing has a sleeve-shaped connection cap that is fitted onto the catheter and radially sandwiches the connection end of the catheter between itself and the connection port, and the connection cap has a locking portion that can be locked into the pair of locking projections. A second aspect of the present invention is a subcutaneous implantable port as described in the first aspect, wherein the deflection-allowing portion is provided while maintaining the height dimension of the locking projection. The invention of the original application The first embodiment is a subcutaneous implantable port having a housing that includes a lumen for storing a drug solution, which is sealed with an elastic lid, and a connection port that communicates with the lumen and is inserted into a catheter, the port having a sleeve-shaped connection cap that is externally fitted onto the catheter and radially sandwiches the connection end of the catheter between itself and the connection port, the connection cap having a locking portion that can be locked to the housing.

[0010] According to the subcutaneous implantable port structure according to this embodiment, the locking portion of the connecting cap is locked to the housing, thereby positioning the connecting cap in the withdrawal direction relative to the connecting port. As a result, the catheter is held in a locked state, sandwiched between the connecting cap and the connecting port, preventing it from coming out, and the catheter remains stably connected to the connecting port. Therefore, the risk of the catheter coming out of the subcutaneous implantable port when it is unintentionally pulled in the withdrawal direction during long-term placement can be reduced.

[0011] The invention of the original application The second aspect is, The invention of the original application In the subcutaneous implantable port described in the first embodiment, a pair of locking protrusions are provided on both sides of the housing in the circumferential direction, flanking the connection port, while a pair of guide surfaces are provided on the inner surfaces of both sides of the housing in the circumferential direction at the base end opening of the connection cap, each widening toward the base end, and the pair of locking protrusions are inserted into the connection cap along the pair of guide surfaces, and the pair of locking protrusions are locked in the withdrawal direction to a pair of locking portions provided behind the pair of guide surfaces.

[0012] According to the subcutaneous implantable port structure in this embodiment, by pushing the connection cap into the connection port, a pair of locking protrusions are guided by a pair of guide surfaces to the locking position with a pair of locking parts. Therefore, the connection cap can be easily positioned relative to the connection port, and the catheter can be easily prevented from coming out by the connection cap.

[0013] A pair of guide surfaces are provided on the inner surface of the base end opening of the connection cap, so that when the connection cap is pushed into the connection port, it is guided to the correct position relative to the connection port. Therefore, the connection cap can be easily and correctly attached, and the pair of locking protrusions and the pair of locking parts are effectively locked in place.

[0014] The invention of the original application The third aspect is, The invention of the original applicationIn the subcutaneous implantable port described in the second embodiment, the locking projection is provided with a deflection-allowing portion located on the base end side and having a reduced cross-sectional area.

[0015] According to the subcutaneous implantable port structure in this embodiment, when attaching the connection cap, the pair of locking protrusions deform to move closer to each other in the bending allowable portion. As a result, when pushing the connection cap into the connection port, the force required to engage the pair of locking protrusions with the pair of locking portions is reduced, making it easier to attach the connection cap.

[0016] The invention of the original application The fourth aspect is, The invention of the original application In the subcutaneous implantable port described in the second or third embodiment, the housing comprises a base housing member that constitutes the bottom wall of the lumen and an outer housing member that clamps the outer peripheral portion of the elastic cover between itself and the base housing member, wherein the connection port is provided on one of the base housing member and the outer housing member, and the pair of locking protrusions are provided on the other of the base housing member and the outer housing member.

[0017] In the subcutaneous embedded port structure according to this embodiment, the connection port and a pair of locking protrusions are provided on one of the base housing member and the outer housing member that constitute the housing. Therefore, the degree of design freedom for the shape of the connection port and the pair of locking protrusions is increased, and the manufacturing of the housing becomes easier.

[0018] The invention of the original application The fifth aspect is, The invention of the original application In a subcutaneous implantable port described in any one of the first to fourth embodiments, the connecting cap has a flattened outer surface shape having two orthogonal axes of different lengths.

[0019] According to the subcutaneous implantable port structured according to this aspect, by providing a portion where the connection cap has a flat outer surface shape, it is easy to grip the flat portion of the connection cap in the short axis direction. Therefore, when pushing the connection cap into the connection port, it is easy to apply force to the connection cap, and the attachment operation of the connection cap becomes easier.

[0020] The invention of the original application The sixth aspect is The invention of the original application In the subcutaneous implantable port described in any one of the first to fifth aspects, the proximal end side of the connection cap has a larger diameter than the distal end side, and a stepped portion is provided on the outer peripheral surface of the connection cap.

[0021] According to the subcutaneous implantable port structured according to this aspect, by pushing the stepped portion, it becomes easier to push and attach the connection cap to the connection port.

[0022] The invention described in the original application The seventh aspect is The invention of the original application In the subcutaneous implantable port described in any one of the first to sixth aspects, the connection cap is formed of a material harder than the distal end side portion that extends to the distal end side of the connection port and is inserted into the catheter by sandwiching the connection side end portion of the catheter in the radial direction between the connection port and the proximal end side portion.

[0023] According to the subcutaneous implantable port structured according to this aspect, the connection side end portion of the catheter is sandwiched in the radial direction between the proximal end side portion of the connection cap made of a relatively hard material and the connection port, so that the catheter is effectively prevented from coming off the connection port. In addition, since the distal end side portion extending to the distal end side of the connection port is formed of a relatively soft material, kinking of the catheter protruding from the connection cap is prevented. Therefore, according to the connection cap according to this aspect, it is possible to achieve both the shape stability required for the proximal end side portion and the flexibility required for the distal end side portion.

[0024] The invention of the original application The eighth aspect is The invention of the original applicationIn the subcutaneous implantable port described in the seventh aspect, the proximal end portion and the tip portion, which are made of different materials, are fixed to each other by a mechanically engaged anchor portion.

[0025] According to the subcutaneous implantable port structured in this embodiment, separation of the proximal portion and the distal portion is more advantageously prevented by mechanical engagement at the anchor portion. [Effects of the Invention]

[0026] According to the present invention, in a subcutaneous implantable port, the connection state to the catheter's connection port is stably maintained. [Brief explanation of the drawing]

[0027] [Figure 1] Perspective view showing a subcutaneous implantable port as a first embodiment of the present invention. [Figure 2] Front view of the subcutaneous implantable port shown in Figure 1. [Figure 3] Plan view of the subcutaneous implantable port shown in Figure 1. [Figure 4] Bottom view of the subcutaneous implantable port shown in Figure 1. [Figure 5] Right side view of the subcutaneous implantable port shown in Figure 1. [Figure 6] Figure 2, section view between VI and VI [Figure 7] Sectional view VII-VII in Figure 2 [Figure 8] Perspective view of the port body constituting the subcutaneous implantable port shown in Figure 1. [Figure 9] Cross-sectional view of the port body shown in Figure 8. [Figure 10] Another cross-sectional view of the port body shown in Figure 8. [Figure 11] Figure 8 shows an exploded perspective view of the housing that constitutes the port body. [Figure 12] Perspective view of the connection cap constituting the subcutaneous implantable port shown in Figure 1. [Figure 13] Cross-sectional view of the connecting cap shown in Figure 12. [Figure 14]Another cross-sectional view of the connection cap shown in Figure 12. [Modes for carrying out the invention]

[0028] Embodiments of the present invention will be described below with reference to the drawings.

[0029] Figures 1-7 show a subcutaneous implantable port 10 as a first embodiment of the present invention. The subcutaneous implantable port 10 has a structure in which a connection cap 14 is attached to a port body 12. In the following description, the vertical direction generally refers to the vertical direction in Figure 2.

[0030] As shown in Figures 8-10, the port body 12 has a structure in which an elastic cover 18 and a port member 20 are attached to a housing 16. The opening of the recess 22 provided in the housing 16 is closed by the elastic cover 18, thereby forming a lumen 24 for storing the drug solution, with the housing 16 and the elastic cover 18 forming the wall portion, and the port member 20 is in communication with the lumen 24.

[0031] The housing 16 is made of a hard synthetic resin or metal and, as shown in Figure 11, is a divided structure having a base housing member 26 and an outer housing member 28. The base housing member 26 is a substantially bottomed cylindrical shape with a peripheral wall portion 30 and a bottom wall portion 32, and a recess 22 opening upward is formed in the central part. The opening portion of the recess 22 is provided with an annular step portion 34, which is formed by notching the inner circumferential corner portion of the peripheral wall portion 30.

[0032] A port portion 36 is provided in a part of the circumferential direction of the peripheral wall portion 30 of the base housing member 26. The port portion 36 is substantially rectangular parallelepiped in shape and is provided by partially thickening the peripheral wall portion 30 outward, protruding from the outer surface of the peripheral wall portion 30. A communication hole 38 is formed in the peripheral wall portion 30 that penetrates the port portion 36.

[0033] A flange-shaped annular projection 40 is formed at the lower end of the base housing member 26, projecting outward. On both sides of the annular projection 40 in the circumferential direction, flanking the port portion 36, a pair of fitting plate portions 42, 42 are formed, projecting more significantly outward.

[0034] The outer housing member 28 is substantially cylindrical in shape and extends in the vertical direction. The upper part of the outer housing member 28 has a tapered shape in which the internal and external dimensions perpendicular to the axis gradually increase toward the bottom. The lower part of the outer housing member 28 has an inner circumferential surface that has a substantially constant internal dimension over substantially the entire circumference, and an outer circumferential surface that has a flared shape in which the external dimension gradually increases toward the bottom.

[0035] The outer housing member 28 is a vertical wall portion 44 having a flat outer peripheral surface in which a portion in the circumferential direction extends in the vertical direction. The vertical wall portion 44 is provided in the housing 16 at a position corresponding to the port portion 36 of the base housing member 26 and is equipped with an opening window 46 that exposes the port portion 36 to the outer periphery.

[0036] The outer housing member 28 is provided with a pair of locking projections 48, 48. The pair of locking projections 48, 48 are substantially rectangular block-shaped. The pair of locking projections 48, 48 protrude from the vertical wall portion 44 in a direction substantially perpendicular to the vertical wall portion 44 on both sides in the width direction of the opening window 46.

[0037] The pair of locking projections 48, 48 are positioned opposite each other and spaced apart in the width direction of the vertical wall portion 44, which is the circumferential direction of the outer housing member 28. The distance between the opposing pairs of locking projections 48, 48 is smaller than the opening width dimension of the opening window 46, and the pair of locking projections 48, 48 protrude from both sides in the width direction onto the opening on the outer circumference of the opening window 46, partially covering the opening window 46. Because the pair of locking projections 48, 48 protrude onto the opening window 46, the base end of each locking projection 48 connected to the vertical wall portion 44 has a smaller width dimension than the rest of the locking projection 48. As a result, the base end of the locking projection 48 is provided with a deflection allowance portion 50 in which the cross-sectional area in the direction perpendicular to the protruding direction of the locking projection 48 is partially reduced.

[0038] Each of the pair of locking protrusions 48, 48 is provided with an engaging projection 52 at its tip that protrudes outward in the width direction. The engaging projection 52 is a ridge with a substantially semicircular cross-section that extends vertically and is continuously provided across the entire vertical length of the locking protrusion 48.

[0039] An annular retaining portion 54 is provided at the opening at the upper end of the outer housing member 28, projecting inward toward the inner circumference. A locking claw 56, with a tapered cross-sectional shape, is formed around the entire circumference of the inner end of the annular retaining portion 54, projecting downward toward the inner circumference.

[0040] As shown in Figure 4, a fitting recess 58 corresponding to the fitting plate portions 42, 42 of the base housing member 26 is formed on the bottom surface of the outer housing member 28. A service hole 60 that penetrates vertically is formed in the portion of the outer housing member 28 adjacent to the outer circumference of the fitting recess 58. The service hole 60 can be used as appropriate, for example, for positioning during manufacturing or installation, or for fixing the outer housing member 28 to the base housing member 26 or port member 20 by providing a fitting pin to the base housing member 26 or port member 20.

[0041] As shown in Figures 9 and 10, the housing 16 is constructed by placing the outer housing member 28 over the base housing member 26 from above and fixing it in an externally fitted state to the peripheral wall portion 30 of the base housing member 26. The port portion 36 of the base housing member 26 is inserted into the opening window 46 of the outer housing member 28. The fitting plate portions 42, 42 of the base housing member 26 are inserted into the fitting recesses 58, 58 of the outer housing member 28. In this way, the base housing member 26 and the outer housing member 28 are positioned in the circumferential direction. The base housing member 26 and the outer housing member 28 are fixed to each other by means of ultrasonic welding or the like, if necessary. Ribs for welding may be provided on the upper surface or the like that overlaps with the inner circumferential surface of the opening window 46, with respect to the port portion 36 of the base housing member 26 that is inserted into the opening window 46 of the outer housing member 28. Furthermore, the position of the welding ribs is not limited to the port portion 36, and welding ribs can be appropriately provided on the overlapping surface of the base housing member 26 and the outer housing member 28. For example, the welding ribs can also be provided on the outer housing member 28 side.

[0042] The port portion 36 of the base housing member 26 is inserted into the opening window 46 of the outer housing member 28, and the pair of fitting plate portions 42, 42 of the base housing member 26 are fitted into the pair of fitting recesses 58, 58 of the outer housing member 28.

[0043] An elastic cover 18 is attached to the housing 16. The elastic cover 18 is made of an elastic material such as elastomer or rubber. The elastic cover 18 has a roughly circular shape with its central axis oriented in the vertical direction.

[0044] The elastic cover 18 is inserted into the inner circumference of the outer housing member 28, and its outer circumference is sandwiched between the peripheral wall portion 30 of the base housing member 26 and the annular retaining portion 54 of the outer housing member 28, compressing its outer circumference in the vertical direction. As a result, the elastic cover 18 is attached to the housing 16 with its outer circumference fluidly tightly supported by the housing 16 over its entire circumference.

[0045] As shown in Figure 10, a contrast ring 62 made of titanium, stainless steel, aluminum, or an alloy thereof is fitted onto the upper outer circumference of the peripheral wall portion 30 of the base housing member 26. By heating the outer surface of the contrast ring 62 with laser light irradiation and applying markings to the outer surface of the contrast ring 62 through oxidation, for example, the manufacturer's name, manufacturing date, lot number, etc., can be displayed. In this case, the outer housing member 28 covering the outer surface of the contrast ring 62 is made of a colorless transparent or colored transparent material that transmits visible light, so that the markings on the contrast ring 62 are visible from the outside. However, the contrast ring 62 is not essential; for example, markings may be made directly on the housing 16 without providing a contrast ring 62.

[0046] When the elastic lid 18 is assembled to the housing 16, a lumen 24 for storing the chemical solution is fluid-tightly defined with respect to the external space, with the elastic lid 18 and the housing 16 forming the walls. The lumen 24 is formed when the opening of the recess 22 in the base housing member 26 is fluid-tightly sealed by the elastic lid 18.

[0047] The lumen 24 is open to the outside through a communication hole 38 provided in the port portion 36 of the base housing member 26. A port member 20 is attached to the communication hole 38 of the base housing member 26. As shown in Figures 9 and 10, the port member 20 is a substantially cylindrical tube with a central hole 64. The port member 20 has a base cylindrical portion 66 and a tip cylindrical portion 68, with the outer diameter of the base cylindrical portion 66 being larger than the outer diameter of the tip cylindrical portion 68. The base cylindrical portion 66 of the port member 20 is provided with a flange-shaped fitting projection 70 that protrudes from its outer circumference. The outer circumference of the tip cylindrical portion 68 of the port member 20 has multiple return-shaped protrusions 72 arranged in the longitudinal direction, which increase in diameter towards the base end side (upper side in Figures 6 and 9).

[0048] The port member 20 is attached to the base housing member 26 by inserting its base end cylindrical portion 66 into the communication hole 38 of the base housing member 26. As a result, the central hole 64 of the port member 20 communicates with the lumen 24 for storing the drug solution through the communication hole 38 of the base housing member 26. The tip cylindrical portion 68 of the port member 20 protrudes from the communication hole 38 of the base housing member 26, and the tip cylindrical portion 68 of the port member 20 constitutes the connection port in this embodiment.

[0049] Furthermore, the outer housing member 28 is assembled from above onto the base housing member 26 with the port member 20 attached. The base housing member 26 and the outer housing member 28 are assembled vertically by inserting the tip cylindrical portion 68 of the port member 20 into the space between the pair of locking protrusions 48, 48.

[0050] When the base housing member 26 and the outer housing member 28 are assembled, the base cylindrical portion 66 (fitting projection 70) of the port member 20 abuts against the pair of locking projections 48, 48 of the outer housing member 28 in the direction in which the port member 20 is withdrawn from the base housing member 26, and is locked in place (see Figure 9). In this way, by assembling the base housing member 26 and the outer housing member 28, the base cylindrical portion 66 of the port member 20 is sandwiched between the base housing member 26 and the outer housing member 28, preventing the port member 20 from falling out of the housing 16. In short, in this embodiment, the structure that prevents the port member 20 from coming out of the housing 16 is constructed using the pair of locking projections 48, 48 provided on the housing 16.

[0051] Furthermore, the outer housing member 28 is provided with an area for accommodating the port portion 36 of the base housing member 26. This allows the width dimension a (see Figure 6) at the base end of the pair of locking projections 48, 48 to be smaller than the width dimension of other parts, thereby forming each deflection-allowing portion 50. In this way, the deflection-allowing portion 50 in this embodiment is provided by reducing the width dimension while maintaining the height dimension of the locking projection 48. The port portion 36 of the base housing member 26 is superimposed on the inner portion in the width direction of the pair of locking projections 48, 48 from the base end side, but a gap is provided between the port portion 36 and the pair of locking projections 48, 48, and this gap allows deformation of the deflection-allowing portion 50. However, this gap is not required. For example, an elastic body may be interposed between the port portion 36 and the pair of locking protrusions 48, 48, allowing deformation of the deflection-allowing portion 50 by the deformation of the elastic body. Alternatively, slight deformation of the port portion 36 and the pair of locking protrusions 48, 48 may also allow deformation of the deflection-allowing portion 50.

[0052] The pair of locking projections 48, 48 of the outer housing member 28 are positioned spaced apart on both sides in the width direction relative to the tip cylindrical portion 68 of the port member 20 that protrudes from the base housing member 26. In other words, when the base housing member 26 and the outer housing member 28 are assembled, the tip cylindrical portion 68 of the port member 20 is positioned between the opposing pairs of locking projections 48, 48.

[0053] The tip cylindrical portion 68 of the port member 20 protrudes beyond the tips of the pair of locking projections 48, 48 of the outer housing member 28, passing between the opposing sides of the pair of locking projections 48, 48. In particular, the portion of the tip cylindrical portion 68 of the port member 20 provided with the convex portion 72 is located further outward than the pair of locking projections 48, 48.

[0054] As shown in Figures 6 and 7, a catheter 74 is attached to the port member 20. The catheter 74 is a flexible tube, and the tip tubular portion 68 of the port member 20 is inserted and connected to the connecting end of the catheter 74. In this way, the catheter 74 communicates with the lumen 24 for drug solution storage of the subcutaneous implantable port 10 via the port member 20. Since the tip tubular portion 68 of the port member 20 has multiple protrusions 72 on its outer surface, the catheter 74, which is fitted in an external state, is difficult to dislodge. One end of the catheter 74 is attached to the port member 20 and connected to the subcutaneous implantable port 10, while the other end is connected to an internal lumen such as a blood vessel.

[0055] A connection cap 14 is attached to the connection portion between the port member 20 and the catheter 74. As shown in Figures 12-14, the connection cap 14 is sleeve-shaped (tubular) overall and has a proximal end portion 76 and a distal end portion 78 made of different materials.

[0056] The base portion 76 is made of a harder material than the tip portion 78, and is formed of, for example, synthetic resin or metal. The base portion 76 integrally includes a bottomed cylindrical connecting portion 80 and a connecting portion 82 that protrudes from the connecting portion 80 toward the tip side (the lower side in Figure 6, 13). The base portion 76 may be made entirely of a single material, or it may be made of a combination of, for example, synthetic resin and metal.

[0057] As shown in Figure 12, the connecting portion 80 has a width dimension W in the circumferential direction of the housing 16 that is larger than the height dimension H in the height direction of the housing 16, and has a flattened outer surface shape with two orthogonal axes (long axis and short axis) of different lengths. In this embodiment, the connecting portion 80 has an oval cross-section as its outer surface. The base end opening 83 of the connecting portion 80 has a roughly rectangular cross-section, and its width dimension w is larger than its height dimension h.

[0058] The inner circumferential surface of the connecting portion 80 is provided with a pair of protrusions 84, 84 that project from both sides in the width direction, which is the longitudinal axis direction of the connecting portion 80. The pair of protrusions 84, 84 are positioned facing each other in the width direction, and the width dimension of the inner circumferential surface of the connecting portion 80 is reduced in the portion where the pair of protrusions 84, 84 are provided. The protruding tip surfaces of the pair of protrusions 84, 84 each widen toward the base end side of the base end opening 83 of the connecting portion 80, or in other words, they are guide surfaces 86 that incline inward in the width direction from the base end side toward the back of the base end opening 83. As a result, in the portion where the pair of protrusions 84, 84 are provided, the width dimension of the inner circumferential surface of the connecting portion 80 gradually increases toward the opening.

[0059] The peripheral wall of the connecting portion 80 is provided with groove-shaped portions 88 extending vertically behind the pair of protrusions 84, 84. The stepped surface, which is both the inner surface of the pair of groove-shaped portions 88, 88 and the side surface behind the pair of protrusions 84, 84, constitutes the pair of locking portions 90, 90 of this embodiment. Thus, the pair of locking portions 90, 90 are provided on the base end portion 76 of the connecting cap 14.

[0060] As shown in Figures 13 and 14, the connecting portion 82 is roughly rectangular in shape, and a pair of anchor holes 92, 92 that penetrate vertically are formed on both sides in the width direction (left-right direction in Figure 13).

[0061] A first through-hole 94 with a circular cross-section is formed in the central part of the width direction of the base end portion 76, extending in the vertical direction and in directions perpendicular to the width direction. In this embodiment, the first through-hole 94 has a tapered shape at the base end, widening in the left-right direction in Figure 13 toward the base end; however, the base end of the first through-hole 94 may have substantially the same cross-sectional shape as the other parts.

[0062] The tip portion 78 is made of a softer material than the base portion 76, and is formed of an elastic material such as synthetic resin elastomer or rubber. As shown in Figures 12-14, the outer shape of the tip portion 78 smoothly changes from a flattened oval shape to a circular shape from the base to the tip. A connecting recess 96 is formed on the base side of the tip portion 78, corresponding in shape to the connecting portion 82 of the base portion 76. A pair of insertion portions 98, 98, corresponding to the pair of anchor holes 92, 92 of the connecting portion 82, extend vertically from the connecting recess 96 and are continuous with both the upper and lower inner surfaces of the connecting recess 96. A second insertion hole 100 is formed in the central portion of the tip portion 78. The second insertion hole 100 is a circular hole corresponding to the first insertion hole 94 and is formed to penetrate from the base to the tip of the tip portion 78.

[0063] The base portion 76 and the tip portion 78 are arranged in series and connected to each other. The connecting portion 82 of the base portion 76 is fitted into the connecting recess 96 of the tip portion 78 and fixed in place. Furthermore, the insertion portions 98, 98 of the tip portion 78 are provided in a state where they are inserted into the anchor holes 92, 92 of the base portion 76, forming a pair of anchor portions 102, 102 that prevent separation of the base portion 76 and the tip portion 78. The base portion 76 and the tip portion 78 may be fixed to each other by means of welding or other means after molding, but in this embodiment, the base portion 76 and the tip portion 78 are molded in a state where they are fixed to each other by insert molding, two-color molding or step molding. As a result, the insertion portions 98, 98 of the tip portion 78 are formed in a state where they are inserted into the anchor holes 92, 92 of the base portion 76.

[0064] As shown in Figures 1-7, the connecting cap 14 is fitted over the tip cylindrical portion 68 of the port member 20 that protrudes from the housing 16. Then, as shown in Figures 6 and 7, the connecting cap 14 is fitted over the port member 20 to which the catheter 74 is attached in its external state, thereby preventing the catheter 74 from coming off the port member 20. In other words, the end of the catheter 74 that connects to the port member 20 is sandwiched between the outer circumferential surface of the port member 20 and the rigid proximal end portion 76 of the connecting cap 14, thereby firmly attaching the catheter 74 to the port member 20.

[0065] The catheter 74 is sandwiched radially between the port member 20 and the connecting cap 14, for example, as follows. That is, the catheter 74 is first externally fitted onto the port member 20 so that it covers the position from the tip of the tip cylindrical portion 68 to the protrusion 72 or beyond the protrusion 72. Preferably, the catheter 74 is inserted to the back side (proximal end side) of the tip faces of the locking projections 48, 48 of the housing 16 and inserted between the locking projections 48, 48. By fitting the catheter 74 not only into the connecting cap 14 but also into the space between the opposing locking projections 48, 48 provided on the housing 16, the connection between the catheter 74 and the port member 20 can be achieved more reliably and stably. In addition, because the catheter 74 is sandwiched between the port member 20 and the locking projections 48, 48, it is less likely that the catheter 74 will come off the port member 20 before the connecting cap 14 is attached to the housing 16. Next, when the connecting cap 14 is placed over the port member 20 on which the catheter 74 is attached, the catheter 74, which is sandwiched between the tip tube portion 68 and the port member 20, moves toward the proximal end of the tip tube portion 68 together with the connecting cap 14, and is externally inserted further toward the proximal end, for example, until it is inserted between a pair of locking protrusions 48, 48. Preferably, the outer diameter of the catheter 74 placed over the tip tube portion 68 of the port member 20 is made larger than the inner diameter of the connecting cap 14, so that the catheter 74 can be efficiently moved toward the proximal end together with the connecting cap 14.

[0066] As shown in Figure 6, the connecting cap 14 is connected to a pair of locking protrusions 48, 48 of the outer housing member 28. That is, when attaching the connecting cap 14 to the outer housing member 28, the tip cylindrical portion 68 of the port member 20 and the catheter 74 are inserted into the first insertion hole 94 and the second insertion hole 100 of the connecting cap 14 and brought close to the outer housing member 28. Then, the pair of locking protrusions 48, 48 of the outer housing member 28 are inserted into the inner circumference of the base end portion 76 of the connecting cap 14 through a pair of guide surfaces 86, 86. The pair of engaging projections 52, 52 provided on the pair of locking protrusions 48, 48 slide in contact with the pair of guide surfaces 86, 86 of the connecting cap 14, overcoming the pair of protrusions 84, 84 and entering the pair of groove-shaped portions 88, 88. As described above, the pair of guide surfaces 86, 86 make it easier for the pair of engaging protrusions 52, 52 to enter the pair of groove-shaped portions 88, 88. When the pair of engaging protrusions 52, 52 enter the pair of groove-shaped portions 88, 88, the pair of engaging protrusions 52, 52 overlap with the pair of protrusions 84, 84 by a predetermined width x in the axial projection, and the pair of engaging protrusions 52, 52 are locked to the pair of locking portions 90, 90 of the connecting cap 14 in the withdrawal direction. As a result, the connecting cap 14 is connected to the outer housing member 28 in a state that prevents it from coming off. In short, the connecting cap 14 is connected to the pair of locking protrusions 48, 48 of the outer housing member 28 by snap-fit.

[0067] In this way, by bringing the connection cap 14 close to the outer housing member 28 and fitting the pair of locking protrusions 48, 48 into the connection cap 14, the connection cap 14 can be easily attached to the connection portion between the port member 20 and the catheter 74. Moreover, the tactile feedback when the pair of engaging protrusions 52, 52 overcome the pair of projections 84, 84 and enter the pair of groove-shaped portions 88, 88 allows the user to confirm that the connection cap 14 and the outer housing member 28 are securely fixed.

[0068] The connecting cap 14 has a flattened base end, and the hard base end portion 76 in particular has a flattened shape, making it easier to apply force to the connecting cap 14 when pushing the pair of locking protrusions 48, 48 into the connecting cap 14. Moreover, in this embodiment, the base end of the tip end portion 78 has a flat outer surface shape, and the tip end of the tip end portion 78 has a circular outer surface, with the base end having a larger diameter than the tip end in the longitudinal direction. As a result, gentle stepped portions 104 are formed on both sides in the longitudinal direction of the outer circumferential surface of the intermediate portion of the tip end portion 78. By applying force to the stepped portions 104, 104 with the user's fingers, it becomes easier to push the connecting cap 14 toward the outer housing member 28. The force applied to the stepped portions 104 is transmitted to the tip surface of the hard base end portion 76 via the soft tip end portion 78. The stepped portion 104 only needs to extend in a direction that intersects the axial direction of the connecting cap 14; for example, it can be formed by a plane that is substantially perpendicular to the axial direction of the connecting cap 14.

[0069] Furthermore, a pair of protrusions 84, 84 are provided on both sides of the connecting cap 14 in the longitudinal direction (width direction). Therefore, by applying a pushing force to both sides of the connecting cap 14 in the width direction, the force can be directly applied to the area where resistance acts when the pair of engaging protrusions 52, 52 overcome the pair of protrusions 84, 84.

[0070] Furthermore, the pair of locking portions 90, 90 of the connecting cap 14 and the pair of locking protrusions 48, 48 of the outer housing member 28 may be in constant contact and locked together. Alternatively, for example, as shown in Figure 6, the pair of locking portions 90, 90 and the pair of locking protrusions 48, 48 may be separated from each other, and the pair of locking portions 90, 90 and the pair of locking protrusions 48, 48 may come into contact and be locked together when the connecting cap 14 is displaced in a direction that allows it to detach from the outer housing member 28.

[0071] The pair of locking projections 48, 48 are positioned spaced apart in the width direction from the tip cylindrical portion 68 of the port member 20. Therefore, when the pair of engaging projections 52, 52 overcome the pair of protrusions 84, 84, the pair of locking projections 48, 48 are allowed to undergo elastic bending deformation in a direction approaching the tip cylindrical portion 68 of the port member 20. In particular, each of the pair of locking projections 48, 48 is provided with a bending allowance portion 50 with a reduced cross-sectional area at its base end, and the bending deformation of the pair of locking projections 48, 48 is advantageously allowed at each bending allowance portion 50.

[0072] The connection cap 14 is fitted into its predetermined position when the pair of locking protrusions 48, 48 are inserted into the connection cap 14 until the bottom inner surface of the connection portion 80 of the connection cap 14 contacts the tip surfaces of the pair of locking protrusions 48, 48. As a result, the tip cylindrical portion 68 of the port member 20 is housed inside the connection cap 14, and the catheter 74, which is fitted onto the tip cylindrical portion 68 of the port member 20, is compressed radially between the port member 20 and the connection cap 14. Consequently, the catheter 74 is prevented from coming out by the fitting of the connection cap 14. Since the tip portion 78 of the connection cap 14 is made of soft material, the inner circumferential surface of the tip portion 78 expands in diameter along the outer circumferential surface of the catheter 74 fitted onto the tip cylindrical portion 68. It is desirable that the inner circumferential surface of the connection cap 14 be smooth without protrusions, thereby preventing damage to the catheter 74 inserted into the connection cap 14.

[0073] Furthermore, when a tensile force is applied to the catheter 74 in the withdrawal direction, the pair of locking portions 90, 90 of the connecting cap 14 and the pair of engaging projections 52, 52 of the pair of locking protrusions 48, 48 of the outer housing member 28 are locked together. This prevents the connecting cap 14 from coming off the pair of locking protrusions 48, 48. Therefore, the connecting cap 14 does not come off the port member 20 together with the catheter 74, and the connection between the catheter 74 and the port member 20 is stably maintained by the connecting cap 14.

[0074] The tip portion 78 of the connecting cap 14, which extends beyond the tip cylindrical portion 68 of the port member 20 and is fitted onto the catheter 74, is made of a softer material than the proximal portion 76, which has a pair of guide surfaces 86, 86 and a pair of locking portions 90, 90. Therefore, kinking of the catheter 74 is less likely to occur at the tip of the connecting cap 14. In addition, the soft tip portion 78 has a cross-sectional shape that changes from circular to oval, with the proximal end being flattened and covering the tip of the hard proximal portion 76. Therefore, when fitting the connecting cap 14 onto the pair of locking protrusions 48, 48, force can be applied to the hard proximal portion 76 via the flexible tip portion 78, making it easier to apply force to the connecting cap 14.

[0075] The rigid proximal portion 76 and the flexible tip portion 78 of the connecting cap 14 are fixed to each other by a pair of anchor portions 102, 102, through which a pair of insertion portions 98, 98 of the tip portion 78 are inserted into a pair of anchor holes 92, 92 of the proximal portion 76. This mechanically connects the proximal portion 76 and the tip portion 78, which are made of different materials, making them inseparable and preventing damage such as disassembly of the connecting cap 14 due to external forces such as tensile force exerted from the catheter 74.

[0076] The widthwise overlap x between the pair of engaging protrusions 52, 52 of the pair of locking projections 48, 48 and the pair of locking parts 90, 90 is not particularly limited, but is preferably about 0.1 mm to 0.25 mm. This allows for effective prevention of the connection cap 14 coming off the pair of locking projections 48, 48 while suppressing the force required to attach the connection cap 14 to the pair of locking projections 48, 48.

[0077] Although embodiments of the present invention have been described in detail above, the present invention is not limited by its specific description. For example, the connecting cap may be formed entirely from a single material, or it may be composed of three or more parts made of different materials.

[0078] In the above embodiment, the connection cap 14 had a flattened outer surface shape at the base end, but the entire cap may have a non-flattened shape such as a cylindrical shape, or the entire cap may have a flattened shape such as an elliptical cylinder, or the tip end or middle portion may have a flattened shape. Furthermore, in a connection cap 14 in which at least a part has a flattened outer surface shape, the long axis direction may be the height direction of the subcutaneous implantable port 10.

[0079] In the above embodiment, the connection cap 14 had a connection portion 80 at the base end portion 76 in which a pair of locking protrusions 48, 48 were inserted and a hole in which the tip cylindrical portion 68 of the port member 20 was inserted were provided connected without a partition. However, for example, a partition may be provided on the inner circumference of the connection portion 80, or the connection portion 80 may be made into a double cylindrical shape, so that the hole in which the pair of locking protrusions 48, 48 were inserted and the hole in which the tip cylindrical portion 68 of the port member 20 and the catheter 74 were inserted may be independent of each other.

[0080] It is desirable that the connecting cap 14 can be removed from the outer housing member 28, for example by pulling it strongly in the pulling direction. The connecting cap 14 can also be fixed to the outer housing member 28 in a way that prevents removal.

[0081] The connection cap 14 and the housing 16 can be attached by locking the protrusions 84, 84 (locking parts 90, 90) of the connection cap 14 and the engaging projections 52, 52 of the housing 16, as in the above embodiment, or in addition to this, by locking them by screw threads and screw grooves, i.e., by a screw-fit structure.

[0082] However, the connecting cap 14 and the housing 16 are preferably connected by locking with protrusions as in the above embodiment. That is, if the connecting cap 14 and the housing 16 are connected by a screw structure (screw-in), it is difficult to sense the fixed end by the tightening operation, so variations or insufficient tightening are likely to occur, and it is difficult to stably achieve a reliable connection state. In contrast, with a recessed locking structure as in the embodiment, it is possible to stably obtain the desired fixed state. Furthermore, the fixing part by screw requires the formation of screw threads or screw grooves around the entire circumference, and since the cross-section becomes a relatively large circle, it becomes difficult to realize a connection structure between the connecting cap and housing where the height dimension is small compared to the width dimension, as in the embodiment. Therefore, the connecting cap will protrude vertically from the housing, making the overall size larger, and gaps are likely to occur due to the step between the two members, which may impair the fluid-tight connection performance of the catheter. In particular, in the above embodiment, a flattened connecting cap is adopted that is larger in the width direction (circumferential direction) compared to the height direction, and a locking structure is provided on both sides in the width direction. This makes it possible to keep the size in the height direction small while setting a large distance from the center of the connecting member to the locking structure. Therefore, in the connected state by the locking structure, it is also possible to keep to a minimum the rattle of the connecting cap relative to the housing caused by rattle of the interlocking protrusions.

[0083] The guide surface 86 is not necessarily limited to being composed of substantially the entire tip surface of the protruding portion 84; for example, a chamfered edge or rounded edge may be provided at the base end corner of the protruding portion 84 in the base end opening 83 of the connecting portion 80.

[0084] The pair of locking protrusions 48, 48 may be provided on the base housing member 26. Furthermore, the housing 16 is not limited to a divided structure having an outer housing member 28 and a base housing member 26, but may be a single structure or composed of three or more divided parts.

[0085] The deflection-allowing portion provided on the pair of locking projections does not necessarily have to be located at the base end of the pair of locking projections; for example, it may be provided in the intermediate portion of the pair of locking projections.

[0086] In the above embodiment, a pair of engaging protrusions 52, 52 provided on the sides of a pair of locking projections 48, 48 enter into a pair of groove-shaped portions 88, 88 provided behind a pair of guide surfaces 86, 86 and are locked into a pair of locking portions 90, 90. However, for example, locking holes may be provided on the sides of the pair of locking projections, and locking projections may be provided behind the pair of guide surfaces that are inserted into the locking holes and locked in the withdrawal direction.

[0087] The catheter 74, which is attached to the tip cylindrical portion 68 of the port member 20 in an externally fitted state, may have its proximal end inserted between a pair of locking projections 48, 48, with its end face in contact with the proximal cylindrical portion 66 of the port member 20. However, the proximal end of the catheter 74 may be located midway between the protruding directions of the pair of locking projections 48, 48, or it may be positioned without reaching between the pair of locking projections 48, 48.

[0088] The catheter 74 may be fixed to the port member 20 by means of adhesive or welding. The catheter 74 can also be fixed to the port member 20 by pressing the catheter 74 against the outer surface of the port member 20 with the connecting cap 14. [Explanation of Symbols]

[0089] 10 Subcutaneous implantable ports 12-port main unit 14 Connection caps 16 Housing 18 Elastic lid 20 Port Components 22 recess 24 lumen 26 Base housing member 28 Outer housing component 30 Peripheral wall part 32 Bottom wall section 34 Annular stepped section 36 Port Section 38 Communication hole 40 Annular projection 42 Fitting plate section 44 Vertical wall section 46 Opening window 48 Locking protrusion 50 Allowable deflection section 52 Engagement protrusion 54 Annular retaining part 56 Locking claws 58 Fitting recess 60 Service Holes 62 Contrast ring 64 Center hole 66 Proximal tube part 68. Tip section (connection port) 70 Fitting projection 72 Convex part 74 Catheter 76 Proximal part 78 Tip side part 80 Connection part 82 Connecting part 83 Proximal opening 84 Protrusion 86 Guide surface 88 Groove 90 Locking part 92 Anchor holes 94 First insertion hole 96 Connecting recess 98 Insertion section 100 Second insertion hole 102 Anchor section 104 Stepped part

Claims

[Claim 1] A subcutaneous implantable port having a housing that includes a lumen for storing a drug solution, which is sealed with an elastic lid, and a connection port that communicates with the lumen and is inserted into a catheter, The housing is provided with a pair of locking protrusions on both sides in the circumferential direction, excluding the portions that face each other vertically across the connection port. The pair of locking protrusions have a flexible portion formed at the base end in the protruding direction, which is thinner than the tip end. The catheter has a sleeve-shaped connecting cap that is externally fitted to the catheter and radially sandwiches the connecting end of the catheter between itself and the connecting port. The connecting cap has the pair of locking protrusions and a lockable locking portion, The housing is provided with an opening window from which the connection port protrudes. The pair of locking protrusions are positioned on the circumferential edges of the opening window and are formed to protrude outward from the housing. Each of the protruding base portions of the locking projections is a subcutaneously implanted port that extends inward toward the opening window in the opposite direction.

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