• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    A sealed valve assembly for a medical product is provided. The valve assembly includes a valve member mountable inside the passageway of the medical product body portion, the valve member including two walls that form a perimeter spaced from the central axis and extend toward the central axis from the perimeter. The walls include ends that contact each other to impede flow through the path. The valve member may be formed of a material having a hardness of about 20 shores or less. The valve member may also have a higher hardness material with other wall structures, or may have a wall member with variable hardness.
    公开号:KR20030080213A
    申请号:KR10-2003-7008106
    申请日:2001-12-17
    公开日:2003-10-11
    发明作者:윌리스알랜에프.；콘린알란
    申请人:킴벌리-클라크 월드와이드, 인크.；
    IPC主号:
    专利说明:

    Sealing Valve Assembly for Medical Products {SEALING VALVE ASSEMBLY FOR MEDICAL PRODUCTS}
    [1] Various types of valves, including sealing mechanisms, are known and widely used in the medical arts. For example, mechanical seal valves are required for various types of catheters, cleaning instruments, and endoscope systems developed for a wide range of medical purposes. The valve sealing mechanism typically excludes the flow of material (in gas or liquid) from one direction through the medical device, for example from the patient to the external environment, while the valve sealing mechanism is directed to the patient through the other direction, eg through the medical device. The influx or flow of the desired substance (food, drugs, etc.) is applied. An enteral feeding device using a gastrostomy catheter ("nutrition tube") uses a sealing valve to prevent gastric liquids, gases, or particles from being unintentionally discharged from the patient's body through the catheter. It is an example of a typical medical instrument to use. US Pat. Nos. 5,997,503 and 5,997,546 both disclose Applicant's assignee and are incorporated herein by reference and disclose balloon catheters suitable for use as skin level gastrosurgery catheter for enteric nutrition. Various other instruments and catheters have been proposed for gastric ulcer nutrition and are known to those skilled in the art.
    [2] Conventional seal valves include duckvill valves, flap valves, slit seal valves, and the like. Silicone rubber duckbill seals having a 50 Shore hardness ratio and a wall thickness of about 0.102 cm (0.040 inch) have been used to seal the gastrosurgery catheter. Such a sealing valve is typically kept closed through the back pressure present on one side of the valve unless it is opened by a pressure differential across the insertion or sealing of the nutrient tube from the other side of the valve and until it is opened.
    [3] Over time, conventional seal valves may somewhat degrade or lose their flexibility (ie, the ability to return to the original seal position after deflection) because of repeated or extended periods of valve opening. In addition, in some body environments, such as an acidic environment of the gastro-intestinal tract, exposure to body fluids or gastric contents may have erosion or other negative effects on the sealing valves over time.
    [4] Therefore, there is a need for an improved medical sealing valve for use in a variety of medical devices, particularly gastrosurgery catheter devices.
    [13] 1 is a perspective view of a medical product, in particular a gastrosurgery catheter, according to the present invention.
    [14] FIG. 2 is a cross-sectional view of the gastrosurgery catheter of FIG. 1 cut along the line A-A of FIG. 1, showing in detail the valve assembly disposed inside the catheter body part.
    [15] 3 is an enlarged cross-sectional view of the valve assembly of FIG. 2 taken along line A-A of FIG.
    [16] 4 is a side view of the first embodiment of the valve member of the valve assembly from the perspective view shown in FIG.
    [17] Figure 5 is a side view of the valve member of Figure 4 rotated 90 degrees.
    [18] 6 is a plan view of the valve member of FIG.
    [19] FIG. 7 is a cross sectional view of the assembly of FIG. 3 with the end of the nutrient tube inserted; FIG.
    [20] 8 is a sectional view of a modification of the valve member.
    [21] 9 is a sectional view of a second modification of the valve member.
    [22] 10 is a sectional view of a third modification of the valve member.
    [5] The objects and advantages of the invention will be set forth in part in the following disclosure, will be apparent from the disclosure, or may be learned by practice of the invention.
    [6] It should be noted that any given range set forth herein is intended to include any and all smaller included ranges. For example, the range of 45-90 also includes 50-90, 45-80, 46-89, and the like.
    [7] In accordance with the present invention, an improved seal valve assembly is provided for use in a wide range of medical products, including catheters, cleaning instruments, endoscope systems, and the like. The valve assembly according to the present invention is not limited to a particular application but can be used in any medical product which applies fluid flow in one direction through the product while preventing the fluid from flowing in the opposite direction through the product. For example, valve assemblies are particularly useful in gastrosurgery catheter. Accordingly, it is to be understood that the present invention also includes a medical product or instrument comprising the valve assembly of the present invention.
    [8] The valve assembly includes a valve housing that forms a path therethrough. The valve member is located in the valve housing inside the path. The valve member includes a perimeter spaced from the central axis of the valve assembly and two walls extending from the perimeter to the central axis. The walls include ends that seal in contact with each other to block flow through the path. The valve member may be formed of a material having a hardness of about 20 shores or less.
    [9] In yet another embodiment, the valve member walls form a tapered cross section from about 0.013 to 0.025 cm (0.005 to 0.010 inch) at their respective sealing end to a thickness of about 0.102 cm (0.040 inch) at a position spaced from the sealing end. can do. The wall can be tapered continuously or discontinuously.
    [10] According to another embodiment of the invention, the at least one valve member wall may form an overlapping portion extending at an angle with respect to the plane of the remaining portion of the wall. This overlapping portion overlaps and is sealed against the portion of the other wall. The overlapping portion may be parallel to the other wall.
    [11] According to another embodiment of the invention, the valve member wall may comprise a first portion comprising a material having about 50 shore hardness and a second portion having a hardness of about 20 shore or less. The second part is arranged at the sealed end of the wall. The first portion is spaced apart from the sealing end.
    [12] The invention will be described in more detail below with reference to the drawings.
    [23] Embodiments of the present invention will now be described in detail with reference to the examples shown in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. Various modifications and variations can be made in the present invention without departing from the scope and spirit of the invention. For example, features shown or disclosed with respect to one embodiment may be used in another embodiment to yield a better embodiment.
    [24] In the following disclosure, an improved sealing mechanism will be disclosed with respect to a gastrosurgery catheter to describe and illustrate the sealing valve assembly. This is not meant as a limitation of the present invention. The improved sealing device according to the present invention is widely applied in the medical field and can be used in any medical device including a seal to apply the flow of material in the opposite direction while preventing the flow of the material in one direction.
    [25] The gastrosurgery catheter 10 is shown in FIGS. 1 and 2 as an example of a medical product comprising an improved valve sealing assembly according to the present invention. The use and operation of such gastrosurgery catheter is known to those skilled in the art and need not be disclosed in detail herein. See US Pat. Nos. 5,997,546 and 5,997,503, which are incorporated herein by reference for a detailed description of gastroscopy catheter.
    [26] As used herein, the term "distal" refers to the direction of the patient and the term "proximal" refers to the direction of the clinician.
    [27] Referring briefly to FIGS. 1 and 2, the gastrosurgery device 10 includes a catheter body part 12 having a head 20, an elastomeric sleeve forming a balloon 16, and a catheter portion 22. . The catheter portion 22 includes a shaft 23 having a dispensing tip 38 attached to its end. The first central opening or port 27 in the head 20 includes a valve housing assembly 14 that enables insertion of nutrients, enteric nutrient solutions, drugs, and the like into the patient through the head 20. The valve housing assembly 14 comprises an improved sealing valve according to the invention, as described in more detail below. The plug 32 may be provided at the end of the lanyard 30 attached to the catheter head 20. Plug 32 may be inserted into first port 27 when the port is not used to administer fluid to a patient.
    [28] The second port 29 in the head 20 functions as an opening through which a fluid, such as air or saline, can be injected into or removed from the balloon 16 through the second lumen 35 having a distal opening 37. . As will be appreciated by those skilled in the art, inflation valve assembly 18 is disposed within second port 29 to authorize the clinician to control the expansion and contraction of balloon 16.
    [29] The valve housing assembly 14 is shown in more detail in FIG. The valve housing assembly 14 includes a valve housing 40 and an improved sealed valve member 42. The valve housing 40 has an annular member 44 and a relatively flat cap member 46 connected to the annular member 44 by, for example, a press-fit or an adhesive. The cap member 46 may have a ridge 48 that fits inside the groove 50 in the annular member 44 to secure the two parts together. The valve housing 40 includes a flange 54 that extends into a corresponding groove in the catheter body part to seat and secure the valve housing in the catheter body part 12. The flange 54 extends radially from the lower tubular portion 58 of the valve housing 40. The tubular portion 58 may have an interior wall that is inclined toward the centerline axis 69 of the valve housing assembly 14. The wall of the tubular portion 58 parallel to the plane of FIG. 3 may be parallel to the axis 69.
    [30] Paths 52 are formed through both portions of the valve housing assembly 14. Path 52 is in fluid communication with nutrient lumen 34 through valve member 42 to introduce nutrients, nutrient solutions, drugs, and the like into the patient's stomach, intestine, or other body cavity. The valve member 42 is disposed inside the path 52 to selectively obstruct the fluid path through the nutrient lumen 34.
    [31] The valve member 42 incorporates the novel features of the present invention, and various embodiments of the valve member 42 are shown in part in FIGS. Referring to FIG. 3, the valve member 42 includes an adjacent flange portion 68 disposed between the annular member 44 and the mating surfaces 64, 66 of the cap member 46. Small circular ridges 60, 62 on the mating surfaces 64, 66 engage the flange portion 68 and help to seat and secure the valve member 42 in place. The valve member 42 includes two walls on opposite sides of the central axis 69, extending from the periphery 68 and inclined from the central axis 69. The walls 70, 72 meet at one sealing boundary 74 formed by the ends 76, 78 of the wall. Portions 68, 70, and 72 form what is known in the art as duckbill valves. As will be explained in more detail below, in order to achieve a satisfactory seal, the thicknesses and side views of the walls 70, 72 vary in various ways according to the invention depending on the hardness of the material used for the valve member 42. Can be designed.
    [32] The sealing cavity 74 is deflected to the closed position and is not forcibly opened by an object inserted into the valve member 42 through the cap member 46 or by a significant pressure differential between the patient's cavity and the external environment. It is held in the closed position by pressure. Objects useful for opening the valve member 42 may be a feeding tube, a feeding tube adapter, or a pressure relief tube. As one example, FIG. 7 shows the valve housing assembly 14 of FIG. 3 with the end of the nutrient tube 108 inserted therein. Pushing in the tube end 108 opens the walls 70 and 72 of the valve member to apply communication with the patient's body cavity through the valve housing 14 and the nutrition lumen 34.
    [33] The various parts of the medical device 10 are preferably formed from a bio-compatible material such as medical silicone. More specifically, the valve member 42 is a fluid injection molding such as MED-4810 (10 Shore Hardness) or MED-4820 (20 Shore Hardness) available from NuSil Technology, Calif., CA. It can be made of silicone elastomer. The valve member is cast, and the sealing boundary 74 is formed by splitting or cutting each wall after casting.
    [34] As mentioned, the thickness and side view of the walls 70, 72 depend on the hardness of the material used to form the valve member 42. For example, for a wall thickness of about 0.102 cm (0.040 inch), the hardness of the valve member may be about 20 or less, may range from about 8 to about 15, and more specifically about 10 days. have. Applicants have found that for valve members, the use of substantially lower hardness materials than conventionally used in the art provides improved sealing and greater sealing flexibility without unexpectedly sacrificing the structural integrity of the valve member.
    [35] However, if the hardness of the valve member 42 is higher, such as up to about 50, as used conventionally, the wall cross section of the valve member may be altered to provide improved sealing flexibility. For example, an alternative to the valve member 42 is shown in FIGS. 8-10.
    [36] 8-9, the valve member has a wall with a variable cross section. In FIG. 8, the valve member 142 includes two walls 170, 172 that are tapered continuously, narrowing towards the sealing boundary 174. The wall may be tapered up to about 15% (percent) of the top wall thickness. For example, walls 170 and 172 may taper from 0.102 cm (0.040 inch) to about 0.013 to 0.025 cm (0.005 to 0.010 inch) at the sealing boundary. In FIG. 9, the valve member 242 has a reduced thickness edge portion having a constant cross-sectional thickness of 0.102 cm (0.040 inch) and a thickness of about 0.013 to 0.025 cm (0.005 to 0.010 inch) along the upper portions 274, 276. Two walls 270 and 272 having 278 and 280. 10, valve member 342 has walls 370 and 372 having a thickness of about 0.102 cm (0.040 inch) throughout. Wall 372 has an edge portion angled with respect to the rest of wall 372. The angled portion 380 is parallel and overlaps with the portion 378 of the wall 370. Overlapping edge portions 378 and 380 may have a thickness and length of about 0.102 cm (0.040 inch).
    [37] Each valve member of FIGS. 8-10 can be molded from a relatively high hardness material, since the modified wall structure provides improved sealing and wall flexibility.
    [38] As another aspect, the valve member 42 having a shape as shown in Figs. 3 to 7 can be molded with a variable hardness that decreases in the direction of the sealing boundary. In such valve members, the periphery 68 and the top of the wall or walls 70, 72 can be made from a material of relatively higher hardness (eg, in the range of about 50 shores) and the remainder lower or It may be made of a progressively decreasing hardness material (eg, decreasing to a range of about 20 shores or less, more specifically about 8 to 15 shores, and even more specifically about 10 shores). Thus, the softer tip of the walls 70, 72 will provide improved sealing when the harder top maintains the shape of the valve member.
    [39] Applicants have therefore disclosed the above numerous design and / or material selections that provide improved sealing of the valve member as well as improved sealing across the sealing boundary of the valve member. Such improved sealing flexibility can provide longer life to medical devices such as gastrosurgery catheter and valve members and associated valve assemblies used therein. Such an improved seal may also provide a more reliable product in terms of reducing or eliminating undesirable leaks.
    [40] It should be understood by those skilled in the art that various modifications and variations can be made within the present invention without departing from the scope and spirit of the invention. It is intended that the present invention cover such modifications and variations as come within the scope of the appended claims and any equivalents thereto.
    权利要求:
    Claims (27)
    [1" claim-type="Currently amended] A valve assembly for use in a medical product with a fluid path,
    The valve assembly is configured to selectively pass fluid in one direction along the fluid path and prevent backflow in the opposite direction along the fluid path,
    The valve assembly includes a valve housing defining an opening having a central axis, and a valve member disposed inside the opening,
    The opening extends through the valve housing to form a fluid path portion through the medical product, the valve member having one sealing boundary formed by at least two opposing flexible walls biased in a sealed position relative to each other, The valve member has a perimeter in which opposing flexible walls extend therefrom toward the central axis, the opposing flexible walls including ends that contact each other along the one sealing boundary,
    And the valve member is formed at least in part from a material having a hardness of about 20 shore hardness or less.
    [2" claim-type="Currently amended] The valve assembly of claim 1, wherein the opposing walls of each valve member have a generally uniform thickness of about 0.102 cm (0.040 inch).
    [3" claim-type="Currently amended] The valve assembly of claim 1, wherein the valve member material has a hardness of about 8 to 15 shores.
    [4" claim-type="Currently amended] The valve assembly of claim 1, wherein the valve member has about 10 shore hardness.
    [5" claim-type="Currently amended] The valve assembly of claim 1, wherein the perimeter and the wall of the valve member form a duckbill valve.
    [6" claim-type="Currently amended] A medical product comprising a valve assembly forming a fluid pathway and disposed in the pathway,
    The valve assembly includes a valve housing defining an opening having a central axis, and a valve member disposed inside the opening,
    The opening extends through the valve housing to form a fluid path portion through the medical product, the valve member having one sealing boundary formed by at least two opposing flexible walls biased in a sealed position relative to each other, The valve member has a perimeter in which opposing flexible walls extend therefrom toward the central axis, the opposing flexible walls including ends that contact each other along the one sealing boundary,
    And the valve member is formed at least in part from a material having a hardness of about 20 shore hardness or less.
    [7" claim-type="Currently amended] The medical product of claim 6, wherein the medical product is a gastrosurgery catheter and the fluid pathway is formed between the cavity of the patient's body and the exterior of the body.
    [8" claim-type="Currently amended] A medical product comprising a valve assembly forming a fluid pathway and disposed in the pathway,
    The valve assembly includes a valve housing defining an opening having a central axis, and a valve member disposed inside the opening,
    The opening extends through the valve housing to form a fluid path portion through the medical product, the valve member having one sealing boundary formed by at least two opposing flexible walls biased in a sealed position relative to each other, The valve member has a perimeter in which opposing flexible walls extend therefrom toward the central axis, the opposing flexible walls including ends that contact each other along the one sealing boundary,
    The at least one flexible wall forms a cross section at each end that is tapered to a thickness of about 10% to about 30% of the thickness extending from the perimeter.
    [9" claim-type="Currently amended] The valve assembly of claim 8, wherein the valve member is formed of a material having a hardness of about 50 shores or less.
    [10" claim-type="Currently amended] The valve assembly of claim 8, wherein the valve member is formed of a material having a hardness of about 20 shores or less.
    [11" claim-type="Currently amended] 9. The valve assembly of claim 8, wherein at least one wall is tapered continuously in a direction towards each end.
    [12" claim-type="Currently amended] The valve assembly of claim 8, wherein the at least one wall changes thickness discontinuously in one direction towards each end.
    [13" claim-type="Currently amended] The method of claim 8, wherein the at least one flexible wall is tapered from about 0.013 to 0.025 cm (0.005 to 0.010 inch) at each end to about 0.102 cm (0.040 inch) at a position spaced from each end. Valve assembly.
    [14" claim-type="Currently amended] A medical product comprising a valve assembly forming a fluid pathway and disposed in the pathway,
    The valve assembly includes a valve housing defining an opening having a central axis, and a valve member disposed inside the opening,
    The opening extends through the valve housing to form a fluid path portion through the medical product, the valve member having one sealing boundary formed by at least two opposing flexible walls biased in a sealed position relative to each other, The valve member has a perimeter in which opposing flexible walls extend therefrom toward the central axis, the opposing flexible walls including ends that contact each other along the one sealing boundary,
    The at least one flexible wall forms a cross section at each end that is tapered to a thickness of about 10% to about 30% of the thickness extending from the perimeter.
    [15" claim-type="Currently amended] The medical product of claim 14, wherein the medical product is a gastrosurgery catheter and the fluid pathway is formed between the cavity of the patient's body and the exterior of the body.
    [16" claim-type="Currently amended] A medical product comprising a valve assembly forming a fluid pathway and disposed in the pathway,
    The valve assembly includes a valve housing defining an opening having a central axis, and a valve member disposed inside the opening,
    The opening extends through the valve housing to form a fluid path portion through the medical product, the valve member having one sealing boundary formed by at least two opposing flexible walls biased in a sealed position relative to each other, The valve member has a perimeter in which opposing flexible walls extend therefrom toward the central axis, the opposing flexible walls including ends that contact each other along the one sealing boundary,
    Wherein at least one of the flexible opposing walls forms an overlapping portion extending at an angle with the at least one wall to overlap with a portion of the other wall adjacent each end.
    [17" claim-type="Currently amended] 17. The valve assembly of claim 16, wherein the valve member is formed from a material having a hardness of about 50 shores or less.
    [18" claim-type="Currently amended] 17. The valve assembly of claim 16, wherein the valve member is formed from a material having a hardness of about 20 shores or less.
    [19" claim-type="Currently amended] 17. The valve assembly of claim 16, wherein the overlapping portion of the at least one wall extends substantially parallel to the other wall.
    [20" claim-type="Currently amended] 17. The valve assembly of claim 16, wherein the wall has a thickness of about 0.102 cm (0.040 inch).
    [21" claim-type="Currently amended] A medical product comprising a valve assembly forming a fluid pathway and disposed in the pathway,
    The valve assembly includes a valve housing defining an opening having a central axis, and a valve member disposed inside the opening,
    The opening extends through the valve housing to form a fluid path portion through the medical product, the valve member having one sealing boundary formed by at least two opposing flexible walls biased in a sealed position relative to each other, The valve member has a perimeter in which opposing flexible walls extend therefrom toward the central axis, the opposing flexible walls including ends that contact each other along the one sealing boundary,
    Wherein at least one of the flexible opposing walls forms an overlapping portion extending at an angle with the at least one wall to overlap with a portion of the other wall adjacent each end.
    [22" claim-type="Currently amended] The medical product of claim 21, wherein the medical product is a gastrosurgery catheter and the fluid pathway is formed between the cavity of the patient's body and the exterior of the body.
    [23" claim-type="Currently amended] A valve assembly for use in a medical product with a fluid path,
    The valve assembly is configured to selectively pass fluid in one direction along the fluid path and prevent backflow in the opposite direction along the fluid path,
    The valve assembly includes a valve housing defining an opening having a central axis, and a valve member disposed inside the opening,
    The opening extends through the valve housing to form a fluid path portion through the medical product, the valve member having one sealing boundary formed by at least two opposing flexible walls biased in a sealed position relative to each other, The valve member has a perimeter in which opposing flexible walls extend therefrom toward the central axis, the opposing flexible walls including ends that contact each other along the one sealing boundary,
    At least one of the flexible opposing walls forms a first portion comprising a material having about 50 shore hardness and a second portion having a hardness of about 20 shore or less, the second portion being at each end of the at least one wall. And the first portion is spaced apart from each end.
    [24" claim-type="Currently amended] The valve assembly of claim 23, wherein the at least one wall has a thickness of about 0.102 cm (0.040 inch).
    [25" claim-type="Currently amended] The valve assembly of claim 23, wherein the second portion of the at least one wall comprises a material having about 10 Shore hardness.
    [26" claim-type="Currently amended] A medical product comprising a valve assembly forming a fluid pathway and disposed in the pathway,
    The valve assembly includes a valve housing defining an opening having a central axis, and a valve member disposed inside the opening,
    The opening extends through the valve housing to form a fluid path portion through the medical product, the valve member having one sealing boundary formed by at least two opposing flexible walls biased in a sealed position relative to each other, The valve member has a perimeter with opposing flexible walls extending therefrom towards the central axis, the opposing flexible walls including an end contacting each other along the one seal,
    At least one of the flexible opposing walls forms a first portion comprising a material having about 50 shore hardness and a second portion having a hardness of about 20 shore or less, the second portion being at each end of the at least one wall. And the first portion is spaced apart from each end.
    [27" claim-type="Currently amended] 27. The medical product of claim 26, wherein the medical product is a gastrosurgery catheter and the fluid pathway is formed between the cavity of the patient's body and the exterior of the body.
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    同族专利:
    公开号 | 公开日
    US6908449B2|2005-06-21|
    WO2002049701A3|2003-02-06|
    AU2002239637B2|2005-11-03|
    JP2004516076A|2004-06-03|
    BR0115602A|2004-02-17|
    DE60123119D1|2006-10-26|
    EP1345648B1|2006-09-13|
    DE60123119T2|2006-12-21|
    AT339235T|2006-10-15|
    NO20032642D0|2003-06-11|
    CA2427459A1|2002-06-27|
    WO2002049701A2|2002-06-27|
    NO20032642L|2003-08-06|
    US20020077604A1|2002-06-20|
    WO2002049701A9|2003-05-15|
    MXPA03005453A|2005-02-14|
    EP1345648A2|2003-09-24|
    AU3963702A|2002-07-01|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    法律状态:
    2000-12-19|Priority to US09/741,730
    2000-12-19|Priority to US09/741,730
    2001-12-17|Application filed by 킴벌리-클라크 월드와이드, 인크.
    2001-12-17|Priority to PCT/US2001/048969
    2003-10-11|Publication of KR20030080213A
    优先权:
    申请号 | 申请日 | 专利标题
    US09/741,730|US6908449B2|2000-12-19|2000-12-19|Sealing valve assembly for medical products|
    US09/741,730|2000-12-19|
    PCT/US2001/048969|WO2002049701A2|2000-12-19|2001-12-17|Sealing valve assembly for medical products|
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