Partitioned hemostasis valve system
Abstract
This record has no abstract on file.
Term
Term ended
Expired 25 May 2020, 6.3 years ago.
- Priority
- Filed
- Granted
- Expired
- Today
13 claims: 3 independent, 10 dependent
- 1下記を備えた分割式の止血弁システム:中心室を形成する、複数の止血弁ハウジング本体部材と、止血弁分離システムとを備えた、分割式の止血弁ハウジング;複数の止血弁部材を備えた、前記中心室内に装着された分割式の止血弁;分割式の止血弁ハウジングに装着された分割式のアダプターシステムであって、スプリット可能なシースを保持する構造を持ち、そして複数のアダプターシステム用サイド部材を備えた、分割式のアダプターシステム;および 分割式のアダプターシステムに装着され、スプリット可能なシースの周囲でシールを形成している分割式のガスケット。
- 2下記を備えた分割式の止血弁システム:中心室を形成する、複数の止血弁ハウジング本体部材と、止血弁分離システムとを備えた、分割式の止血弁ハウジング;複数の止血弁部材を備えた、前記中心室内に装着された分割式の止血弁;分割式の止血弁ハウジングに装着された分割式のアダプターシステムであって、スプリット可能なシースを保持する構造を持ち、そして複数のアダプターシステム用サイド部材を備えた、分割式のアダプターシステム;分割式のアダプターシステムに装着され、スプリット可能なシースの周囲でシールを形成している分割式のガスケット;および 分割式のアダプターシステムに装着されたスプリット可能なシース。
- 3分割式の止血弁ハウジングが複数のキャップ部材を備えた分割式のキャップをさらに備え、キャップ部材の1つにより分割式の止血弁部材の1つが分割式の止血弁ハウジング本体部材の1つに装着されている、請求項1または2記載の分割式の止血弁システム。
- 4分割式の止血弁ハウジングに装着された延長管を有するサイドポートをさらに備えた、請求項1ない3のいずれかに記載の分割式の止血弁システム。
- 5分割式 の 止血弁部材の1つが分割式の止血弁ハウジング本体部材の1つに装着されている請求項1ないし4のいずれか記載の分割式の止血弁システム。
- 6分割式の止血弁ハウジング本体部材の1つが溝つき部をさらに備え、第2の分割式の止血弁ハウジング本体部材がトング部をさらに備え、該トング部が該溝つき部の中に嵌合する、請求項5記載の分割式の止血弁システム。
- 7分割式の止血弁ハウジング本体部材の1つがスナップ嵌め具をさらに備え、第2の分割式の止血弁ハウジング本体部材が凹部をさらに備え、このスナップ嵌め具と凹部が相互作用して、分割式の止血弁ハウジング本体部材を一緒に閉じて保持する、請求項1ないし6のいずれかに記載の分割式の止血弁システム。
- 8止血弁分離システムが、それぞれ分割式の止血弁ハウジングに装着されている複数の羽根部材、この羽根部材の中に設けたピボットピン穴、ピボットピン、およびスプリングを備えている、請求項1ないし7のいずれかに記載の分割式の止血弁システム。
- 9スプリングの力で止血弁ハウジング本体部材を一緒に保持している、請求項8記載の分割式の止血弁システム。
- 10羽根部材の外側エッジに加えた圧力により分割式の止血弁ハウジング本体部材が離れるように動く、請求項8または9記載の分割式の止血弁システム。
- 11分割式の止血弁部材の一方に装着された延長シールをさらに備えた、請求項5記載の分割式の止血弁システム。
- 12延長シールが分割式の止血弁ハウジング本体部材の1つに装着された延長脚部分をさらに備える、請求項11記載の分割式の止血弁システム。
- 13延長脚部分が分割式の止血弁ハウジング本体部材の1つに設けた溝の中に固定可能なトング部分をさらに備える、請求項12記載の分割式の止血弁システム。
Independent claims13
1 paragraph, as filed
[0001] [Technical field to which the invention belongs] The present invention relates to the field of hemostatic valves. More specifically, the present invention is within a partitioned hemostatic valve housing for attachment to a splittable sheath used during introduction of a medical device, preferably a pacemaker lead, into the human body. The present invention relates to a split hemostatic valve system with a split hemostatic valve housed in the. [0002] [Conventional technology] There are many medical procedures that require the introduction of medical devices into arteries and veins. In one example of such a procedure, called the Seldinger procedure, a needle is used to surgically open a vein or artery. The guide wire is then inserted into a vein or artery through the lumen of the needle. When the needle is pulled out, the guide wire remains in place. Next, the dilator placed inside the attached sheath is inserted through the guide wire. Once the sheath is in place, remove the dilator and guide wire. The sheath can then be used as a conduit to prevent damage to the vessel wall and various catheters or leads can be inserted into the vessel through the lumen of the sheath. [0003] In conventional procedure, these sheaths are often equipped with a hemostatic valve. Hemostatic valves are often designed for use with specific size catheters. Such hemostatic valves are disclosed, for example, in US Pat. Nos. 5,092,857 and 4,909,798. [0004] In medical procedures where the pacemaker lead is inserted into the patient, a sheath is usually used to guide the pacemaker lead in place. The sheath must be removed before the pacemaker lead can be permanently fixed in place and attached to the pacemaker. The outer end of the pacemaker lead contains a connecting connector for connecting to the pacemaker, and due to the size of the sheath cavity, the sheath does not easily slide around the outer end of the pacemaker lead. [0005] Therefore, many sheaths used when introducing pacemaker leads have been disclosed so far that the pacemaker leads can be surrounded but split in half. When using this, after introducing the pacemaker lead wire to a predetermined position, the sheath is cut in the longitudinal direction and taken out from the pacemaker lead wire. [0006] For example, U.S. Pat. No. 4,983,168 No. discloses such a layered stripped hollow sheath. In this sheath, the sheath wall consists of at least two layers. That is, it is a layer consisting of an inner cylindrical layer and two outer semi-cylindrical segments, and an axial slit or slot facing each other is formed between the two segments of the outer layer to form a tear line. .. [0007] U.S. Pat. No. 4,596,559 discloses a tear sheath for use in a disposable introducer set combined with a catheter. U.S. Patent Reissue No. 31,855 discloses a sheath with an internal molecular orientation that tears easily in the longitudinal direction and is very difficult to tear in the transverse or diagonal direction. See also U.S. Pat. No. 4,581,025. Longitudinal knurled or perforated sheaths are disclosed in US Pat. Nos. 4,166,469; 4,243,050; 4,345,606 and 4,451,256. Locking dilators for use in stripped sheaths are disclosed in US Pat. No. 5,098,392. [0008] These can be split (can be torn) Problems appeared when using the sheath. During the introduction of pacemaker leads, significant amounts of bleeding may occur at the surgical site, depending on the blood pressure present in the blood vessels. Once the sheath is in place within the blood vessel, it provides a passage for the free outflow of blood from the surgical site. [0009] In addition, due to this blood flow, blood coagulation can occur if the sheath stays in place for a long time. Blood clots produced by coagulation can cause embolisms, which can be sent to the lungs and have a detrimental impact on the patient. [0010] These sheaths can also serve as passages for the introduction of air into the blood vessels. Careless introduction of air into the blood system can cause air embolism, which can have a negative effect on the patient. [0011] Due to these problems, the splittable sheath is removed from the surgical site as quickly as possible, even if it is preferable to keep it in place for a longer period of time. Such urgent procedures can lead to mistakes or medical complexity. [0012] One way to prevent or at least limit the outflow of blood from the sheath while introducing a pacemaker lead is for the doctor to press the exposed end of the sheath with the thumb, or between the thumb and index finger. Crush or pinch the exposed end of the sheath with. However, none of these methods of reducing the undesired flow of blood and air through the sheath is undesirable as there are still opportunities for blood loss and air influx. Also, the structure of these sheaths requires the surgeon to hold them in their hands while they are in place within the blood vessel, thus limiting the surgeon's ability to perform other medical procedures at the same time. Moreover, crushing the exposed ends of the sheath can deform or even damage the sheath, making it difficult to insert the lead or when the lead passes through the sheath. Increased risk of damage. Furthermore, pressing the ends of the sheath or pinching the sheath does not completely stop the outflow of blood from the sheath. [0013] Therefore, it may be useful to introduce a hemostatic valve in the sheath to restrict blood flow during the introduction of pacemaker leads into the heart or other similar medical procedures. However, since the outer end of the pacemaker lead is larger than the opening of the conventional hemostatic valve, it is not possible to pass the pacemaker lead through the conventional hemostatic valve. [0014] Therefore, tearable hemostatic valves housed in splittable sheaths for the introduction of pacemaker leads are disclosed, for example, in US Pat. Nos. 5,312,355 and 5,125,904. Each of these patents discloses a splittable sheath valve body (16), a splittable sheath valve assembly (14) and a splittable valve membrane (22). After placing the pacemaker lead in the heart, apply pressure to the flanges (38, 40) of the splittable sheath valve body (16) to remove the splittable sheath valve assembly (14) from around the lead. Reed (34,) the splittable sheath valve body (16) and the splittable sheath valve assembly (14). 36) Tear and release along. The splittable valve membrane (22) is also splittable membrane (22) along the weakened or knurled lines of the splittable membrane (22) during this procedure, or as shown in US Pat. No. 5,312,355. ), Tear and release along the Y-shaped cut. [0015] Another valve system incorporated into a splittable sheath for the introduction of pacemaker leads is disclosed in US Pat. No. 5,441,504. A slidable valve (70) mounted on the tab (62) of the sheath (40) can slide to cover the opening of the sheath (40) when the pacemaker lead is introduced. If it becomes necessary to remove the sheath (40) from the surgical site, leave the sheath (40) attached to one tab 62) of the splittable sheath (40) on both sides of the slidable valve (70). Tear along the notch (86). [0016] Another splittable sheath with a splittable valve is U.S. Pat. No. 5,397,311 and 5,755,693. It is disclosed in the issue. These patents provide for a single valve (30, 30A, 30B or 30C) housed within the body of the splittable sheath (18) to block the flow of blood through the splittable sheath (18). A valve system containing a pair of valves (78, 80) is disclosed. The valve can include a pair of semi-circular members, each of which can include slits, for example, as shown in FIGS. 7 and 8 of these patents. [0017] Another splittable sheath system with a split valve is disclosed in US Pat. No. 5,613,953. The valve members (82 and 82A) are part of the handle of the splittable sheath and are separated into separate half valves by the separation of the exposed handles (90 and 90A) of the splittable sheath. Handle and valve members are rotatable link assemblies (100, Synergistically connected by 100A), the link assembly is biased to the closed position by an integrally formed bias spring. [0018] [Problems to be Solved by the Invention] The instruments that have been disclosed so far have often been difficult to split when used in medical procedures due to the presence of fluids, especially blood. Also, when tearing these prior art instruments, blood splatters often occur when tearing the hemostatic valve. In addition, the valves often split unevenly, making it more difficult to remove the splittable sheath and splittable valves. Some doctors hesitate to thread a pacemaker lead tine through such a valve. This is because there is a risk that the valve will damage the branch line. [0019] Moreover, some physicians may try to delay the introduction of the hemostatic valve into the sheath, even after the sheath has already been placed in place. In addition, it is sometimes necessary to remove the hemostatic valve from the surgical site at some point while the sheath is still in use. [0020] That is, it is important to have a device to hold a separate hemostatic valve separate from the splittable sheath itself. It is also important to provide an improved split device for holding a split hemostatic valve that can be attached to a splittable sheath and used to introduce pacemaker leads into the heart. Is. [0021] [0021] Therefore, one object of the present invention is to provide an improved split hemostatic valve system. Another object of the present invention is to provide a split hemostatic valve system that can be attached to a separate, splittable sheath for the introduction of medical devices into the heart, especially pacemaker leads. [0022] Another object of the present invention is to disclose a split hemostatic valve system with an adapter system for mounting the hemostatic valve system on a splittable sheath. [0023] Yet another object of the present invention is to disclose a split hemostatic valve system that is housed inside a split hemostatic valve housing and includes a split hemostatic valve and a splittable sheath. [0024] Yet another object of the present invention is to disclose a split hemostatic valve system that can be attached to a splittable sheath and can be removed from the splittable sheath without tearing the hemostatic valve. [0025] Yet another object of the present invention is to disclose a split hemostatic valve system with a split hemostatic valve housing including a split hemostatic valve and a hemostatic valve separation system. [0026] Yet another object of the present invention is to provide a split hemostatic valve for use with a splittable sheath that allows the splittable sheath to be removed from a position surrounding the electrode leads without tearing. To disclose the formula hemostatic valve system. [0027] Yet another object of the present invention is to disclose a split hemostatic valve system housed inside a split hemostatic valve housing that is locked in the closed position and unlockable in the open position. [0028] Another object of the present invention is to disclose a split hemostatic valve housing with a swivel vane portion that moves the separated side members of the split hemostatic valve together. Yet another object of the present invention is to disclose a split hemostatic valve system comprising a split hemostatic valve formed from a pair of hemostatic valve members joined together by an extension seal. [0029] The above and other objects and features of the present invention will be apparent to those skilled in the art from the following detailed description and claims. The following description, together with the accompanying drawings, shows the configuration of a particular example of an instrument for exemplifying the present invention. [0030] [Means for solving problems] According to the present invention, a split-type hemostatic valve housing having a central chamber, a split-type hemostatic valve mounted in the central chamber, and a split-type hemostatic valve housing are mounted, and both the housing and the hemostatic valve are split-type members. A split hemostatic valve system is provided with a hemostatic valve separation system designed to allow separation and a split adapter system that allows the split hemostatic valve system to be attached to a splittable sheath. To. [0031] Preferably, the hemostatic valve separation system comprises a swivel vane portion, a pivot pin hole, a pivot pin, and a spring that acts together on a separate member of the split hemostatic valve. [0032] A method of using this split hemostatic valve system is also disclosed, which method involves introducing a splittable sheath into a blood vessel and mounting the splittable hemostatic valve system in a splittable sheath. Here, the split hemostatic valve system is applied to a split hemostatic valve housing having a central chamber, a split hemostatic valve mounted in the central chamber of the split hemostatic valve housing, and a split hemostatic valve housing. It is equipped with a hemostatic valve separation system that is mounted and has a structure that allows the separation of the housing and the split members of the hemostatic valve. [0033] BEST MODE FOR CARRYING OUT THE INVENTION The split hemostatic valve system (10) of the present invention is mounted inside a split hemostatic valve housing (12), a central chamber (13) within the housing (12), as shown in FIGS. 1 and 2. A split hemostatic valve (14), a hemostatic valve separation system (16) that forms one element of the split hemostatic valve housing (12), and a splittable sheath (20) with a split hemostatic valve system (10). ) Is equipped with an adapter system (18) mounted on a split hemostatic valve housing (12). [0034] The split hemostatic valve housing (12) is a dilator (300), catheter or pacemaker lead or other medical device, as shown in FIG. 3, in the central chamber (13) of the split hemostatic valve housing (12). It is provided with first (34) and second (36) facing open ends so that it can be inserted through. As shown in FIGS. 3, 4 and 5, the split hemostatic valve housing (12) also has a pair of cap members (22, 24) mounted on top of the pair of hemostatic valve body members (26, 28). Be prepared. The cap members (22, 24) and body members (26, 28) that make up the split hemostatic valve housing (12) are made of relatively hard plastic such as ABS resin or high density polyethylene. Cap members (22, 24) are separately attached to separate body members (26, 28), respectively, by conventional fixing methods such as ultrasonic bonding, heat sealing, or gluing. [0035] As shown in FIG. 3, the main body member (26, A split hemostatic valve (14) is mounted inside the central chamber (13) of 28). This split hemostatic valve (14) is preferably formed from two hemostatic valve members (38, 40). Each member (38, 40) of the split hemostatic valve (14) is mounted inside one of the main body members (26, 28) of the split hemostatic valve housing (12). Each member (38, 40) of the split hemostatic valve (14) is a conventional hemostatic valve material such as flexible and elastic rubber such as silicone rubber, latex rubber or foam rubber (20-60 durometer hardness). They can be shaped to fit inside the individual body members (26, 28) of the split hemostatic valve housing (12). [0036] In a preferred embodiment, the split hemostatic valve (14) is provided with two members of the same size, one attached to each of the main body members (26, 28) of the split hemostatic valve housing (12). It consists of 38, 40). Alternatively, the valve member (38, 40) of the split hemostatic valve (14) and the body member (26, 40) of the split hemostatic valve housing (12). 28) can be made from multiple members of the same or different sizes. [0037] Each hemostatic valve member (38, 40) is located inside any of the body members (26, 28) of the split hemostatic valve housing (12), preferably in place by the individual cap members (22, 24). It is attached to. As shown in FIGS. 3 and 5, each cap member (22, 24) has an upper portion (42) of each hemostatic valve member (38, 40) and each main body member of the split type hemostatic valve housing (12). It is sandwiched between the upper lip (30, 32) of (26, 28). [0038] In a preferred embodiment, one hemostatic valve member (38) is a mirror image of the other hemostatic valve member (40). A pair of hemostatic valve members (38,) constituting the split hemostatic valve (14) The overall shape when combined 40) is the same as or different from the overall shape of a conventional hemostatic valve, as disclosed in U.S. Pat. Nos. 5,192,857, 5,092,857 and 4,909,798. You may. However, when the split hemostatic valve (14) is mounted inside the split hemostatic valve housing (12), it is not physically fixed to each other and is combined by the action of the split hemostatic valve housing (12). It is important that it is pushed by and held in the state of a separate hemostatic valve member (38, 40). [0039] The hemostatic valve members (38, 40) of the split hemostatic valve (14) are preferably formed in a unique shape, as shown in FIGS. 6, 7, 8 and 9. Each hemostatic valve member (38, 40) is an upper surface (42) that is sandwiched between each cap member (22) and the upper surface of each main body member (26), and a receiving portion (42) into which a medical device can be inserted. 50) and. The receptor (50) extends downward into the neck opening (52) through which the medical device passes. The neck opening (52) connects the receptor (50) to the seal chamber (54). The seal chamber (54) connects the neck opening (52) to the lip (56) of the hemostatic valve member (38), as best shown in FIGS. 6, 8 and 9. [0040] As shown in FIGS. 7 and 9, the outer wall (58) of the hemostatic valve member (38) has a lower inwardly inclined portion (60) and an upper portion (62) that are inclined inward as they approach the lip (56). And have. The inwardly sloping portion (60) of this outer wall (58) serves to support the lip (56) when combined with the corresponding lip (56) of the other synergistic hemostatic valve member (40). .. Also, by inclining inward towards the lip, the inwardly inclined portion (60) of the outer wall (58) allows the medical device to leave without applying excessive force as it passes through the lip (56). Gives space to Lip (56). The inwardly inclined portion (60) of the outer wall (58) is preferably tilted at an angle of about 35 to about 75 ° from the position of the upper part (62), even when the medical device is pushed between the lips (56). , Apply pressure to the lip to keep the lip (56) closed against the corresponding lip of the cooperating partner hemostatic valve member (40). [0041] Further, the upper portion (62) preferably extends downward from the upper surface (42), preferably perpendicular to the upper surface (42), and communicates with the inner wall surface of the seal chamber (54) to be inside the outer wall (58). Gives additional support for the oriented slope (60). To prevent the lip from opening when pressure is not applied to the lip by a medical device, another tilt member (not shown) that slopes inward toward the lip (56) is placed on the outer wall near the lip (56). It may be provided in (58). [0042] When the main body members (26, 28) of the split hemostatic valve housing (12) are brought together, the hemostatic valve members (38, 40) that are separated from each other are pressed against each other to form the completed split hemostatic valve (14). It is formed. [0043] In a preferred embodiment, the split hemostatic valve housing (12), when attached to the hemostatic valve separation system (16), has a schematic shape in the form of clothespins, as shown in FIGS. 3, 4 and 5. Take. As shown in FIG. 5, the split hemostatic valve separation system (16) has a blade member (70, 71) and a pair of pivot pin holes (72, 71) existing in each blade member (70, 71). It is equipped with a 74), a pivot pin (76), and a spring (78). The pivot pin (76) is inserted into a pair of pivot pin holes (72, 74) provided in each of the blade members (70, 71). [0044] The spring (78) is located around the pivot pin (76) and is held in place between the pair of holes (72, 74) in each blade member (70, 71). The spring (78) preferably has a pair of extension arms (80, 81), each of which extends outward from the spring (78) and is an inner surface (82, 84) of each blade member (70, 71). ), Which corresponds to the inner surface (82, 84) of each blade member (70 and 71) between the pair of support ribs (83, 85). The spring (78) is held around the pivot pin (76) under tension so that the arm (80, 81) pulls the blade members (70 and 71) apart and the split hemostatic valve housing (12) accordingly. Inner edge (90, 91, Push 92 and 93) together, thus closing the split hemostatic valve housing (12), as shown in Figures 1-4. In this configuration, the individual body members (26, 28) of the split hemostatic valve housing (12) were also completed by pushing in the individual hemostatic valve members (38, 40) of the split hemostatic valve (14) together. A split hemostatic valve (14) is formed. [0045] The internal pressure applied to the blade members (70, 71) separates the individual hemostatic valve members (38, 40) of the split hemostatic valve (14) and separates the individual hemostatic valve members (38, 40). When sufficient internal pressure is applied to the outer surface (86, 88) of each blade member (70, 71), each body member (26, 28) is around the pivot pin (76), as shown in FIGS. 2 and 3. Turn with to reach the open position. All structures that allow the individual body members (26, 28) of the split hemostatic valve housing (12) to be opened and closed as described herein are within the scope of the invention. [0046] Preferably, the inner edges (90, 91, 92, 93) of each body member (26, 28) of the split hemostatic valve housing (12) are the body member (26, 28, 93). 28) Formed into a structure that aids in joining and sealing. For example, in one preferred embodiment, as shown in FIG. 3, the inner edges (90, 91) on both sides of one body member (26) of the split hemostatic valve housing (12) are grooved (97, 97). The opposing edges (92, 93) on both sides of the corresponding other body member (28) include tongs (94, 95) that fit into the grooved portion (96, 97). Helps tighten the two body members (26, 28) together. This tongue-in-groove system consists of individual elements of the body member (26, 28), individual hemostatic valve members (38, 40) and individual side members (114, of the adapter system (18)). It also helps to align 116). [0047] In another embodiment, an extension seal (64) is attached to one of the hemostatic valve members (38, 40), as shown in FIGS. 10 and 11. This extension seal (64) is a hemostatic valve member (38,) of the split hemostatic valve (14). 40) Helps to seal together. This extension seal (64) is a thin seal generally formed in the shape of the inner edge of the hemostatic valve member (38) and is attached to the inner edge of the hemostatic valve member (38) by a conventional sealing method such as adhesion. May be good. However, in a preferred embodiment, the extension seal (64) is formed as an integral element of the hemostatic valve member (38) when the hemostatic valve member (38) is formed. Preferably, the extension seal (64) includes a pair of extension leg portions (66, 67) that extend downward from the hemostatic valve member (38). The extension leg portion corresponds to the inner surface (90, 91) of each main body member (26). [0048] In one preferred embodiment, as shown in FIG. 11, the back side of the extension leg portion (66, 67) is provided with a tong portion (68, 69). These tongs (68, 69) fit into grooves (96, 97) provided on the inner edges (90, 91) of each body member (26). The extension seal (64) is made of the same material as the split hemostatic valve (14) and helps seal not only the individual hemostatic valve members (38, 40) but also the individual body members (26, 28). [0049] Two body members (26, It is preferred to equip the split hemostatic valve housing (12) with a locking system (100) to further aid holding the 28) in the closed position as shown in FIGS. 1 and 4. In one preferred embodiment, as shown in FIGS. 3 and 4, the locking system (100) comprises an external snap member (102) mounted on one body member (26) of the split hemostatic valve housing (12). It cooperates with the concave member (104) mounted on the other main body member (28). Two body members (26, When the components of the split hemostatic valve housing (12) are firmly held in the closed position by bringing 28) close to each other, the snap member (102) fits into the recessed member (104), so that the split hemostatic valve The possibility of blood leakage from the system (10) is reduced. [0050] In one embodiment, the side port (120) as shown in FIGS. 1, 2 and 3 is attached to one of the main body members (28) of the split hemostatic valve housing (12). This side port (120) provides access to the central chamber (13) of the split hemostatic valve housing (12). If a side port (120) is used, attachments such as an extension tube (122) and stopcock (124) are attached to this side port (120) to allow fluid to be introduced from the split hemostatic valve housing (12). It may be possible to extract. [0051] In a preferred embodiment, as shown in FIGS. 3, 4 and 5, the split hemostatic adapter system (18) is a cap member (22, From 24), it is attached to the opposite end of the split hemostatic valve housing (12). The adapter system (18) is designed to hold the splittable sheath (20) firmly, for example, as shown in FIGS. 1 and 2. In one preferred embodiment, the split adapter system (18) comprises a pair of side members (114, 116). When the two side members (114, 116) are combined together, the T of the splittable sheath (20), as disclosed in Figure 3 of U.S. Pat. No. 5,098,392 (incorporated here for reference). A structure is created in which the upper part of the shape is held in the split hemostatic valve housing (12). [0052] 1 In a preferred embodiment, a split gasket (112, 113) as shown in FIG. 5 is attached to the split adapter system (18). At this time, one half (112) of the gasket is attached to one side member (114) of the adapter system (18), and the other half (113) is attached to the other side member (116) of the adapter system (18). It will be installed. These gaskets (112, 113) is preferably formed from a heavy-duty rubber-like material, such as 10-40 durometer silicone rubber, to form a sealing seal around the T-fit of the splittable sheath (20). .. [0053] As shown in FIGS. 1 and 2, this splittable sheath (20) is generally elongated and substantially cylindrical, preferably with a handle (204) secured to its front end (206). Consists of a shaped tube (202). It can be formed from any suitable plastic material, preferably polyethylene or tetrafluoroethylene plastic, and the plastic used is one that is compatible with body fluids, especially blood. The tube (202) has a front end (206) and a distant end (208), and is provided along the length of the tube (202) and is shallow in the longitudinal direction carved inside. It has a mechanically formed longitudinally thinned zone (not shown) created by grooves or recesses. The handle (204) preferably comprises a pair of handle members (212) protruding vertically outward from the cylindrical tube (202). Handle member (212) When pressure is applied to the top surface of the tube (202), the tube (202) tears for removal from the patient. [0054] At the time of surgery, the patient's blood vessels are first punctured with a needle. A guide wire is passed through the cavity of the needle and inserted into a blood vessel. The next time the needle is removed, the guide wire remains in the blood vessel, but part of it is exposed. The dilator (300) and splittable sheath (20) are then routed together through a guide wire into the blood vessel. After that, the splittable sheath (20) is advanced to a predetermined part in the body, and the guide wire and the dilator (300) are taken out. The far end of the medical device, such as a pacemaker lead, is then passed through a splittable sheath (20) and advanced into its location within the patient's body. A split hemostatic valve system (10) is then passed through a medical device or lead and around the handle (204) of the splittable sheath (20) over its anterior end (206). Installing. The installation of this system can be done at any time during medical treatment, before or after the leads are placed in the sheath (20). Split gasket (112,) for split adapter system (18) The 113) forms an airtight fit around the handle (204) of the splittable sheath (20) and holds it firmly in place, with the handle (204) of the splittable sheath (20) and split hemostasis. Prevents blood from leaking to and from the valve system (10). Since the pair of hemostatic valve members (38, 40) are pushed and integrated, the split hemostatic valve (14) acts like a conventional hemostatic valve, minimizing the amount of blood loss during the procedure. .. [0055] Once the pacemaker leads have been placed in place, the swivel blade members (70, 71) can be pushed closer together to open the split hemostatic valve system (10). As a result, the main body member (26, 28) and the hemostatic valve member (38, 40) of the split type hemostatic valve housing (12) are opened. By opening the split hemostatic valve housing (12), the splittable sheath (20) is also loosened from the hemostatic valve system (10). Split hemostatic valve member (38, Since 40) also leaves during this procedure, the split hemostatic valve system (10) can be removed from the surgical site. However, since the split hemostatic valve (14) has not yet been pulled apart, the split hemostatic valve system (10) can be reattached to the splittable sheath (20) if required, depending on the appropriate medical procedure. The splittable sheath (20) may then be removed from the surgical site by applying downward pressure to the handle member (212) to tear it apart. [0056] Although the specific embodiment of the present invention has been illustrated and described above, it will be clear from the above that various changes can be made without departing from the technical idea and scope of the present invention. [Simple explanation of drawings] FIG. 1 is a perspective view of a split hemostatic valve system with a side port extension with a dilator inserted inside and a stopcock attached, the split hemostatic valve system mounted on a splittable sheath. ing. FIG. 2 is an exploded perspective view of the split hemostatic valve system of FIG. 1 with an expander, side port extension with stopcock and splittable sheath. FIG. 3 is a perspective view of a split hemostatic valve system in which the body member of the split hemostatic valve housing is in an open position. FIG. 4 is a perspective view of a split hemostatic valve system mounted on a side port extension with a stop cock in which the body member of the split hemostatic valve housing is in a closed position. FIG. 5 is an exploded perspective view showing a split hemostatic valve system with a side port extension with a stop cock. FIG. 6 is a perspective view of one of the split hemostatic valve members of the split hemostatic valve. 7 is a perspective view when the hemostatic valve member of FIG. 6 is rotated by 180 °. 8 is a plan view of the split hemostatic valve member of FIG. 6. FIG. 9 is a side sectional view of the split hemostatic valve member of FIG. 8 along line 9-9. FIG. 10 is a perspective view of another aspect of the present invention showing an extension seal attached to one of the split hemostatic valve members of the split hemostatic valve. 11 is a perspective view of a split hemostatic valve member of another aspect of FIG. 10 rotated by 180 °. [Explanation of symbols] 10: Split hemostatic valve system, 12: Split hemostatic valve housing, 13: Central chamber, 14: Split hemostatic valve, 16: Hemostasis valve separation system, 18: Split adapter system, 20: Splittable sheath, 22 , 24: Cap member; 26, 28: Housing body member, 38, 40: Hemostasis valve member, 50: Receptor, 52: Neck opening, 54: Seal chamber, 56: Lip, 60: Inwardly inclined part, 62: Upper part, 64: Extension seal part, 66, 67: Extension leg part , 68, 69: tongs, 70, 71: blade members, 72, 74: pivot pin holes, 76: pivot pins, 78: springs, 80, 81: extension arms, 83, 85: ribs, 94, 95: tongs Part, 96, 97: Grooved part, 100: Lock system, 102: Snap member, 104: Recess member, 120: Side port, 122: Extension tube, 124: Stopcock, 202: Cylindrical tube, 212: Handle member, 300: Expander
Every citation, both ways
| Document | Relation | Office |
|---|---|---|
| US05755693A | Cites | United States of America |
| US05312355A | Cites | United States of America |
| DE03834600B | Cites | Germany |
38 members in 7 offices
Priority claims8
| Document | Office | Kind | Date |
|---|---|---|---|
| 20729598 | United States of America | A | |
| 20729598 | United States of America | A | |
| 2309126 | Canada | A | |
| 2309126 | Canada | A | |
| 2000154742 | Japan | A | |
| CA20002309126 | – | – | – |
| JP20000154742 | – | – | – |
| US19980207295 | – | – | – |
Members38
| Document | Office | Kind | |
|---|---|---|---|
| US5423772A | United States of America | A | |
| US5549581A | United States of America | A | |
| CA2166260A1 | Canada | A1 | |
| EP0745406A2 | European Patent Office (EPO) | A2 | |
| JPH08322939A | Japan | A | |
| EP0745406A3 | European Patent Office (EPO) | A3 | |
| US5643231A | United States of America | A | |
| US5722963A | United States of America | A | |
| CA2166260C | Canada | C | |
| US5984909A | United States of America | A | |
| US6001085A | United States of America | A | |
| US6083207A | United States of America | A | |
| CA2376875A1 | Canada | A1 | |
| WO0100268A1 | World Intellectual Property Organization (WIPO) | A1 | |
| US6277107B1 | United States of America | B1 | |
| CA2309126A1 | Canada | A1 | |
| JP2001327608A | Japan | A | |
| US2002029030A1 | United States of America | A1 | |
| EP1189654A1 | European Patent Office (EPO) | A1 | |
| US6458107B1 | United States of America | B1 | |
| EP0745406B1 | European Patent Office (EPO) | B1 | |
| AT246944T | Austria | T | |
| ATE246944T1 | Austria | T1 | |
| DE69629418D1 | Germany | D1 | |
| US6623460B1 | United States of America | B1 | |
| JP2003529394A | Japan | A | |
| US6656166B2 | United States of America | B2 | |
| DE69629418T2 | Germany | T2 | |
| US6758854B1 | United States of America | B1 | |
| EP1189654B1 | European Patent Office (EPO) | B1 | |
| AT276006T | Austria | T | |
| ATE276006T1 | Austria | T1 | |
| DE60013823D1 | Germany | D1 | |
| DE60013823T2 | Germany | T2 | |
| CA2309126C | Canada | C | |
| JP4244552B2 | Japan | B2 | |
| CA2376875C | Canada | C | |
| JP4655331B2This record | Japan | B2 |
24 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Cancellation because of no payment of annual feesLAPS | LAPS | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Renewal fee payment (event date is renewal date of database)FPAY | FPAY | |
| Certificate of patent or registration of utility modelJAPANESE INTERMEDIATE CODE: R150R150 | R150 | |
| Certificate of patent or registration of utility modelJAPANESE INTERMEDIATE CODE: R150R150 | R150 | |
| First payment of annual fees (during grant procedure)JAPANESE INTERMEDIATE CODE: A61A61 | A61 | |
| Written decision to grant a patent or to grant a registration (utility model)JAPANESE INTERMEDIATE CODE: A01A01 | A01 | |
| Written decision to grant a patent or to grant a registration (utility model)JAPANESE INTERMEDIATE CODE: A01A01 | A01 | |
| Decision of grant or rejection writtenTRDD | TRDD | |
| Written amendmentJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Notification of reasons for refusalJAPANESE INTERMEDIATE CODE: A131A131 | A131 | |
| Written amendmentJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Notification of reasons for refusalJAPANESE INTERMEDIATE CODE: A131A131 | A131 | |
| Written amendmentJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Written permission of extension of timeJAPANESE INTERMEDIATE CODE: A602A602 | A602 | |
| Written request for extension of timeJAPANESE INTERMEDIATE CODE: A601A601 | A601 | |
| Written permission of extension of timeJAPANESE INTERMEDIATE CODE: A602A602 | A602 | |
| Written request for extension of timeJAPANESE INTERMEDIATE CODE: A601A601 | A601 | |
| Notification of reasons for refusalJAPANESE INTERMEDIATE CODE: A131A131 | A131 | |
| Written request for application examinationJAPANESE INTERMEDIATE CODE: A621A621 | A621 |
Numbers
- Publication
- 4655331
- Publication, DOCDB
- 4655331
- Publication, EPODOC
- JP4655331B
- Application
- 154742
- Application, DOCDB
- 2000154742
- Application, EPODOC
- JP20000154742
Titles2
- Japanese
- 分割式の止血弁システム
- English
- Split hemostatic valve system
Classification
- CPC, 6
- A61M39/06
- A61M25/0668
- A61M2039/0633
- A61M2039/0646
- A61M2039/0653
- A61M2039/0686
- IPC, 4
- A61M25 08
- A61M39 00
- A61M25 06
- A61M39 06