阅读说明：本技术 止血阀以及制作与使用止血阀的方法 (Hemostatic valve and methods of making and using same ) 是由 萨米特·阿格拉沃尔 皮尤什·托马尔 于 2018-02-28 设计创作，主要内容包括：公开了止血阀以及制造和使用止血阀的方法。一种示例性止血阀可包括具有远端区域和近端区域的主体。第一密封部件可设置于所述主体的所述近端区域内。芯筒可至少部分地设置于所述主体的所述近端区域内。所述芯筒可包括第二密封部件。所述芯筒可具有形成于其上的一个或多个突出。所述主体的所述近端区域可具有形成于其中的一个或多个凹入。所述一个或多个凹入可设计为接合所述一个或多个突出。柱塞可联接至所述主体的所述近端区域。(Hemostatic valves and methods of making and using hemostatic valves are disclosed. An example hemostasis valve may include a body having a distal region and a proximal region. A first sealing member may be disposed within the proximal region of the body. A cartridge may be disposed at least partially within the proximal region of the body. The cartridge may include a second sealing member. The cartridge may have one or more protrusions formed thereon. The proximal end region of the body may have one or more recesses formed therein. The one or more recesses may be designed to engage the one or more protrusions. A plunger may be coupled to the proximal end region of the body.)

1. A hemostatic valve, comprising:

a body having a distal region and a proximal region;

a first sealing component disposed within the proximal region of the body;

a cartridge disposed at least partially within the proximal region of the body, the cartridge including a second sealing component;

wherein the cartridge has one or more protrusions formed thereon;

wherein the proximal region of the body has one or more recesses formed therein, wherein the one or more recesses are designed to engage the one or more protrusions; and

a plunger coupled to the proximal end region of the body.

2. The hemostasis valve of claim 1, wherein the one or more recesses comprise one or more grooves formed along an inner surface of the proximal region of the body.

3. The hemostasis valve of claim 1, wherein the one or more recesses comprise one or more slits formed along the proximal region of the body.

4. The hemostasis valve of any one of claims 1-3, wherein engagement of the one or more protrusions with the one or more recesses is configured to limit rotation of the cartridge relative to the proximal region of the body.

5. The hemostasis valve of any one of claims 1-4, further comprising an annular member disposed along an outer surface of the proximal region of the body.

6. The hemostasis valve of any one of claims 1-5, wherein the proximal region of the body includes one or more threads.

7. The hemostasis valve of claim 6, further comprising a nut threadably engaged with the one or more threads.

8. The hemostasis valve of any one of claims 1-7, wherein the cartridge comprises two protrusions positioned along opposite sides of the cartridge.

9. The hemostasis valve of any one of claims 1-8, wherein the proximal region of the body includes two recesses.

10. A hemostatic valve, comprising:

a body having a distal region, a side port, and a proximal region;

a high pressure seal member disposed within the proximal region of the body;

a cartridge disposed at least partially within the proximal region of the body, the cartridge including a low pressure seal component;

wherein the cartridge has one or more protrusions formed thereon;

wherein the proximal region of the body has one or more recesses formed therein that are designed to engage the one or more protrusions to thereby limit rotation of the cartridge relative to the proximal region of the body; and

a plunger coupled to the proximal end region of the body.

11. The hemostasis valve of claim 10, wherein the one or more recesses comprise one or more grooves formed along an inner surface of the proximal region of the body.

12. The hemostasis valve of claim 10, wherein the one or more recesses comprise one or more slits formed along the proximal region of the body.

13. The hemostasis valve of any one of claims 10-12, wherein the cartridge comprises two protrusions positioned along opposite sides of the cartridge.

14. The hemostasis valve of any one of claims 10-13, wherein the proximal region of the body includes two recesses.

15. A hemostatic valve, comprising:

a body having a threaded proximal end region;

a nut in threaded engagement with the threaded proximal region;

a first sealing component disposed within the proximal region of the body;

a cartridge disposed at least partially within the threaded proximal region of the body, the cartridge including a second sealing component;

wherein the cartridge has a pair of opposing projections formed thereon; and is

Wherein the threaded proximal region of the body has a pair of opposing recesses formed therein that are designed to engage the protrusions to thereby limit rotation of the cartridge relative to the threaded proximal region of the body.

Technical Field

The present disclosure relates to medical devices, and methods for making medical devices. More particularly, the present disclosure relates to hemostatic valves and methods of making and using hemostatic valves.

Background

Many medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guide wires, catheters, and the like. These devices are manufactured by any of a variety of different manufacturing methods, and may be used according to any of a variety of methods. In known medical devices and methods, each has particular advantages and disadvantages. There is a need for: alternative medical devices and alternative methods of making and using medical devices are provided.

Disclosure of Invention

The present disclosure provides designs, materials, methods of use, and alternatives for use of medical devices. An example hemostasis valve is disclosed. The hemostatic valve includes: a body having a proximal region and a distal region; a first sealing component disposed within the proximal region of the body; a cartridge disposed at least partially within the proximal region of the body, the cartridge including a second sealing component; wherein the cartridge has one or more protrusions formed thereon; wherein the proximal region of the body has one or more recesses formed therein that are designed to engage the one or more protrusions; and a plunger coupled to the proximal end region of the body.

Alternatively or additionally to any of the embodiments above, the one or more recesses comprise one or more grooves formed along an inner surface of the proximal region of the body.

Alternatively or additionally to any of the embodiments above, the one or more indentations comprise one or more slits formed along the proximal region of the body.

Alternatively or additionally to any of the embodiments above, engagement of the one or more protrusions with the one or more recesses is designed to limit rotation of the cartridge relative to the proximal region of the body.

Alternatively or additionally to any of the embodiments above, further comprising an annular member disposed along an outer surface of the proximal region of the body.

Alternatively or additionally to any of the embodiments above, the proximal region of the body comprises one or more threads.

Alternatively or additionally to any of the embodiments above, further comprising a nut in threaded engagement with the one or more threads.

Alternatively or additionally to any of the embodiments above, the cartridge comprises two protrusions located along opposite sides of the cartridge.

Alternatively or additionally to any of the embodiments above, the proximal region of the body comprises two recesses.

A hemostatic valve is disclosed. The hemostatic valve includes: a body having a distal region, a side port, and a proximal region; a high pressure seal member disposed within the proximal region of the body; a cartridge disposed at least partially within the proximal region of the body, the cartridge including a low pressure seal component; wherein the cartridge has one or more protrusions formed thereon; wherein the proximal region of the body has one or more recesses formed therein that are designed to engage the one or more protrusions, thereby limiting rotation of the cartridge relative to the proximal region of the body; and a plunger coupled to the proximal end region of the body.

Alternatively or additionally to any of the embodiments above, the one or more recesses comprise one or more grooves formed along an inner surface of the proximal region of the body.

Alternatively or additionally to any of the embodiments above, the one or more recessed blog forms one or more slits along the proximal region of the body.

Alternatively or additionally to any of the embodiments above, the cartridge comprises two projections positioned along opposite sides of the cartridge.

Alternatively or additionally to any of the embodiments above, the proximal region of the body comprises two recesses.

A hemostatic valve is disclosed. The hemostatic valve includes: a body having a threaded proximal end region; a nut in threaded engagement with the threaded proximal region; a first sealing component disposed within the threaded proximal region of the body; a cartridge disposed at least partially within the threaded proximal region of the body, the cartridge including a second sealing component; wherein the cartridge has an opposing pair of projections formed thereon; and wherein the threaded proximal region of the body has an opposing pair of recesses formed therein that are designed to engage the protrusions to thereby limit rotation of the cartridge relative to the threaded proximal region of the body.

Alternatively or additionally to any of the embodiments above, the recess comprises a groove formed along an inner surface of the threaded proximal region of the body.

Alternatively or additionally to any of the embodiments above, the recess comprises a slit formed along the threaded proximal region of the body.

Alternatively or additionally to any of the embodiments above, further comprising a plunger coupled to the threaded proximal end region of the body.

Alternatively or additionally to any of the embodiments above, the first sealing member comprises a high pressure seal.

Alternatively or additionally to any of the embodiments above, the second sealing member comprises a slit (cut), a cut (slit), or a slit having formed therein.

The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The figures and the detailed description that follow more particularly exemplify these embodiments.

Brief Description of Drawings

The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

fig. 1 is a perspective view of an exemplary hemostasis valve.

Fig. 2 is a deployment view of an exemplary hemostasis valve.

Fig. 3 is a cross-sectional view taken along line 3-3 in fig. 1.

Fig. 4 is a cross-sectional view of an exemplary hemostasis valve.

Fig. 5A-5B are cross-sectional views of exemplary hemostatic valves.

Fig. 6 is a perspective view of a portion of an exemplary hemostasis valve.

Fig. 7 is a perspective view of a portion of an exemplary hemostasis valve.

Fig. 8 is a perspective view of a portion of an exemplary hemostasis valve.

Fig. 9 is a perspective view of a portion of an exemplary hemostasis valve.

While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It will be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

All numerical values herein are to be considered as modified by the term "about" unless expressly indicated otherwise. The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited range (e.g., having the same function or effect). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the context clearly dictates otherwise.

It is noted that references in this specification to "an embodiment", "some embodiments", "other embodiments", and the like, indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such references do not necessarily imply that all embodiments include the particular feature, structure, and/or characteristic. Additionally, when a particular feature, structure, and/or characteristic is described in connection with an embodiment, it is understood that unless explicitly stated to the contrary, such feature, structure, and/or characteristic may also be used in connection with other embodiments, whether or not explicitly described.

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

Some medical procedures, such as intravascular procedures, utilize medical devices within a body lumen. For example, endovascular procedures include the placement of guidewires, guide catheters, interventional devices, and the like into a blood vessel. As fluid (e.g., blood) under pressure occurs within the blood vessel, the fluid may travel along or through the medical device and flow or leak out of the patient. In some instances, it may be desirable to provide a hemostasis valve or hemostasis valve assembly at the proximal end of the medical device, thereby reducing or otherwise limiting fluid/blood leakage out of the proximal end of the device.

An exemplary hemostasis valve 10 is shown in fig. 1. The hemostatic valve 10 includes a body 12. The body 12 may include a side port 14. The side port 14 may be connected to another device, such as an infusion device, an inflation device, or the like. An adapter 16 may be coupled to the distal end of the body 12. The adapter 16 may be used to couple the hemostatic valve 10 to a device, such as a catheter. A plunger 18 may be coupled to the proximal end of the body 12. The plunger 18 may be used to activate or otherwise close a seal within the hemostatic valve 10 (as discussed herein). These and other features of the hemostatic valve 10 are discussed herein.

Fig. 2 is a deployed view of the hemostatic valve 10. Here, the elements of the hemostatic valve 10 are visible. For example, the hemostatic valve 10 may include a cartridge 20. The cartridge 20, which may include two pieces 20a and 20b coupled to one another (e.g., pressure fit, thermal bond, adhesive bond, etc.), may be configured such that at least a portion of the cartridge may be disposed within the proximal end region 22 of the body 12. A first seal member 24 may be disposed within the cartridge 20. A second sealing member 26 may be disposed within the proximal end region 22 of the body 12. In at least some examples, the second sealing member 26 can be disposed distally of the cartridge (cartridge) 20. The second sealing member 26 may include a textured distal surface, grooves, wells, or the like formed therein. Additionally or alternatively, the second sealing member 26 may include a closer region having a reduced diameter. Nut 28 may be coupled to the proximal region 22 of the body 12 at, for example, one or more threads 30 formed along the proximal region 22.

Other features of the hemostatic valve 10 visible in fig. 2 include a spring member 32 and an O-ring 34. The spring member 32 may be coupled to the plunger 18. In at least some examples, the spring member 32 may be designed to exert a proximally directed force on the plunger 18. The O-ring 34 may be positioned adjacent to the adapter 16. Additionally, a ring-shaped member or "snap ring" 36 may be disposed along the proximal region 22 of the body 12.

Fig. 3 is a cross-sectional view of the hemostatic valve 10. Some of the structural features of the hemostatic valve 10 can be seen here. For example, the hemostatic valve 10 may include an intermediate cavity 38. In general, the intermediate cavity 38 is designed to be placed in fluid communication with one or more cavities of a device coupled to the adapter 16. A second or infusion lumen 40 may be confined adjacent the side port 14. The second cavity 40 may be in fluid communication with the intermediate cavity 38.

As described above, the hemostatic valve 10 may be designed such that it may be coupled to another device. For example, the adapter 16, which adapter 16 may take the form of a Tuohy-Borst or other type of connector, may engage the proximal end of another device. When connected (and with the plunger 18 in the configuration shown in fig. 3), the second sealing member 26 may be in an open state or configuration. Conversely, when the hemostatic valve 10 is connected to another device (and when the plunger 18 is in the configuration shown in fig. 3), the first sealing member 24 may be in a closed or sealed configuration.

Collectively, when the hemostatic valve 10 is connected to another device and in the configuration depicted in fig. 3, the hemostatic valve 10 can substantially maintain a fluid seal, substantially preventing backflow and/or leakage of bodily fluids (e.g., blood). At some point during a medical intervention, it may be desirable to input additional fluid, such as contrast media, through the hemostasis valve 10. This may include attaching an infusion set to the side port 14. Because the second sealing member 24 may be designed to substantially prevent backflow and/or leakage of relatively low pressure fluid, it may be possible that infusate may be able to flow past the first sealing member 24 if the infusion set is infusing fluid at a relatively high rate.

To prevent backflow of relatively high pressure fluids, the hemostasis valve 10 may be actuated to close or "seal" the second sealing member 26. To do so, the plunger 18 may be urged distally until facing distally, with a proximal surface or cap 42 of the plunger 18 disposed adjacent a proximal region 43 of the nut 28, as shown in fig. 4. When doing so, the tubular region 46 of the plunger 18 may extend through (and open) the first sealing member 24. Additionally, a portion of the plunger 18 may be moved distally beyond the annular member 36. With the cap 42 of the plunger 18 disposed adjacent the nut 28, the plunger 18 may be rotated (e.g., in a clockwise direction) to close the second sealing member 26, as shown in fig. 5A. This rotation may cause the nut 28 to rotate and move distally. Since the distal end region of the nut 28 is engageable with the cartridge 20, distal movement of the nut 28 urges the cartridge 20 distally within the proximal end region 22 of the body 12 to cause the cartridge 20 to engage the second sealing member 26 and deform the second sealing member 26, thereby switching the second sealing member 26 to a closed or sealed configuration. The plunger 18 may be released or otherwise allowed to move proximally, as shown in fig. 5B, which may reclose the first sealing member 24 (while the second sealing member 26 remains closed).

Rotation of the nut 28 causes the nut 28 to translate and engage the cartridge 20, which in turn engages and closes the second sealing member 26. Typically, axial movement of the cartridge 20 exerts a force on the second sealing member 26, which closes or "seals" the second sealing member 26. If the rotational movement of the nut 28 causes the cartridge 20 to rotate, this may result in a rotational force being initially applied to the second sealing member 26. If this occurs, the second sealing member 26 may become deformed/distorted such that the second sealing member may not be able to completely close or seal the primary cavity 38. It may be desirable to limit the rotational force applied to the cartridge 20 and/or the second sealing member 26. Disclosed herein are hemostatic valves designed to limit such forces.

Fig. 6 illustrates a portion of an exemplary hemostasis valve 110, the hemostasis valve 110 being similar in form and function to other hemostasis valves disclosed herein. Although only a portion of the hemostasis valve 110 is shown, it is understood that the remainder of the hemostasis valve 110 can include structures similar or identical to those described above in connection with the hemostasis valve 10. In this example, the proximal region 122 of the body 112 may include one or more slits or recesses 148. In addition, the cartridge 120 may include one or more fins or protrusions 150. The fins 150 may fit within the recesses 148 when the cartridge 120 is disposed within the proximal region 122 of the body 112. When an axial force is applied to the cartridge 120 (e.g., via the nut 28), the cartridge 120 will begin to translate relative to the body 112. When this is done, the protrusion 150 will shift along the indentation 148, as shown in fig. 7. Due to the structural relationship between the protrusion 150 and the recess 148, rotation of the cartridge 120 is reduced or otherwise mitigated as the cartridge moves distally within the proximal end region 122.

It will be appreciated that several variations are contemplated for the hemostasis valve 110. For example, in some examples, the proximal region 122 may include a single indentation 148, two indentations 148, three indentations 148, four indentations 148, or more. The recess 148 may be configured in a number of suitable ways. In some embodiments, the indentations 148 may be evenly spaced across the proximal region 122. Alternatively, the recesses 148 may be non-uniformly spaced. Similarly, the cartridge 120 may include a suitable number of protrusions 150, such as one, two, three, four, five, six, or more. The protrusions 150 may be evenly or unevenly spaced about the cartridge 120. In some examples, the number of protrusions 150 and the number of indentations 148 may be the same. Alternatively, the number of the protrusions 150 may be different from the number of the recesses 148.

Fig. 8 illustrates a portion of an exemplary hemostasis valve 210, the hemostasis valve 210 being similar in form and function to other hemostasis valves disclosed herein. In this example, the proximal region 222 of the body 212 may include one or more internal grooves 248. In addition, the cartridge 220 may include one or more fins or protrusions 250. The protrusion 250 may extend along a portion of the length or a portion of the length of the cartridge 220. The fins 250 may fit within the slots 248 when the cartridge 220 is disposed within the proximal region 222 of the body 212. As such, rotation of the cartridge 220 is reduced or otherwise mitigated as the cartridge is moved distally within the proximal region 222, as shown in fig. 9.

Materials that may be used for the components of the hemostatic valve 10 (and/or other hemostatic valves disclosed herein) and the components disclosed herein may include those associated with medical devices. For purposes of brevity, the following discussion refers to the body 12 and other components of the hemostasis valve 10. However, there is no intent to limit the devices and methods described herein, as the discussion is applicable to the other hemostatic valves and/or components thereof disclosed herein.

The body 12 and/or other components of the hemostatic valve 10 may be made of: metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer compositions, ceramics, combinations thereof, and the like, or other suitable materials. Some examples of suitable polymers may include Polytetrafluoroethylene (PTFE), tetrafluoroethylene (ETFE), fluoroethylene propylene (FEP), polyoxymethylene (POM, e.g., available from dupont) Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM engineering plastics corporation)) Ether or ester based copolymers (e.g., butylene/poly (alkylene ether) phthalate and/or other polyester elastomers such as available from dupont) Polyamides (e.g. obtainable from bayer)Or from Elf Atochem)) Elastomeric polyamides, polyamide/ether blocks, polyether block amides (PEBA, e.g. under the trade nameCan be obtained byOf (a), ethylene-vinyl acetate copolymer (EVA), silicone, Polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., ethylene-vinyl acetate copolymer), Polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, and polyethylene) Polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether sensitizers (PEEK), Polyimides (PI), polyether amides (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly (hydroquinone) terephthalate (e.g.,) Polysulfone, nylon-12 (such as available from EMS American Grilon)) Perfluoro (propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVDC), poly (styrene-b-isobutylene-b-styrene) (e.g., SBS and/or SBS 50A), polycarbonate, ionomer, biocompatible polymer, other suitable material, or mixtures, combinations, copolymers, polymer/metal combinations thereof, and the like. In some embodiments, the jacket may be mixed with a Liquid Crystal Polymer (LCP). For example, the mixture may contain up to about 6% LCP.

Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels; mild steel; nickel titanium alloys, such as linear elastic and/or superelastic nickel titanium alloys; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as625. UNS: N06022, such asUNS N10276, such asOtherAlloys, etc.); nickel-copper alloys (e.g. UNS: N04400, such as400、400、400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such asEtc.), nickel-molybdenum alloys (e.g., UNS: N10665, such asALLOY) Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; a cobalt chromium alloy; cobalt chromium molybdenum alloys (e.g., UNS: R30003, such asEtc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material.

It should be understood that this disclosure, in many respects, is only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent appropriate, using any of the features of one example in other embodiments. The scope of the invention is, of course, limited by the language in which the appended claims are expressed.