# US 2019/0167967 A1 · Hemostasis valve systems and associated methods

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- Number: US 2019/0167967 A1
- Document ID: US20190167967A1
- Status: Published application
- Kind: A1
- Application number: 16/204,596
- Filed: 2018-11-29
- Published: 2019-06-06
- Earliest claimed: 2017-12-01
- Assignees: Merit Medical Systems, Inc.
- Applicants: Merit Medical Systems, Inc.
- Inventors: Jim Mottola; Mark Garcia; Fred Lampropoulos
- Web page: https://patentgrep.com/patent/US20190167967A1

## CPC

- A61M 39/0693: {including means for seal penetration}
- A61B 17/3462: {with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals (expandable cannulas A61B17/3417)}
- A61M 25/09: Guide wires
- A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)}
- A61B 17/3498: {Valves therefor, e.g. flapper valves, slide valves (haemostasis valves A61M39/06; check valves A61M39/24)}
- A61B 2017/3445: {used as instrument channel for multiple instruments}
- A61B 2017/3466: {for simultaneous sealing of multiple instruments}
- A61M 25/0662: {Guide tubes}
- A61M 2039/0264: {with multiple inlets or multiple outlets}
- A61M 2039/0279: {for introducing medical instruments into the body, e.g. endoscope, surgical tools}
- A61M 2039/0626: {used with other surgical instruments, e.g. endoscope, trocar}
- A61M 2039/064: {Slit-valve}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Hemostasis valves and hemostasis valve systems are provided. A hemostasis valve can include a valve member, wherein the valve member includes a first sealable opening disposed through a first portion of the valve member and a second sealable opening disposed through a second portion of the valve member. The valve member may also include three or more sealable openings. A hemostasis valve system may include a hemostasis valve and another medical device. The hemostasis valve may be releasably coupleable to the other medical device.

## Claims

### Claim 1

A method of disposing a guidewire through a hemostasis valve, the method comprising:
introducing an insertion device through a first sealable opening of a hemostasis valve;
obtaining a guidewire, wherein the guidewire is disposed through a valved medical device;
inserting a proximal end of the guidewire through an opening at a distal end of the insertion device; and
displacing the guidewire through a portion of the insertion device such that the proximal end of the guidewire is disposed proximal of each of the hemostasis valve and the valved medical device.

### Claim 2 (depends on 1)

The method of claim 1, further comprising coupling the hemostasis valve to the valved medical device.

### Claim 3 (depends on 2)

The method of claim 2, wherein when the hemostasis valve is coupled to the valved medical device a lumen of the hemostasis valve is in fluid communication with a lumen of the valved medical device and the hemostasis valve bypasses a valve of the valved medical device.

### Claim 4 (depends on 1)

The method of claim 1, further comprising displacing the proximal end of the guidewire through a side opening disposed adjacent a proximal portion of the insertion device.

### Claim 5 (depends on 1)

The method of claim 1, further comprising removing the insertion device from within the hemostasis valve such that the guidewire remains disposed through each of the hemostasis valve and the valved medical device.

### Claim 6 (depends on 5)

The method of claim 5, further comprising inserting a second guidewire through a second sealable opening of the hemostasis valve and displacing the second guidewire through each of the hemostasis valve and the valved medical device.

### Claim 7

A method of using a hemostasis valve having multiple sealable openings, the method comprising:
disposing an insertion device through a first sealable opening or a second sealable opening of a hemostasis valve;
displacing the insertion device along a proximal portion of a first guidewire that is disposed through a valved medical device; and
removing the insertion device from within the hemostasis valve when the first guidewire is disposed through each of the hemostasis valve and the valved medical device.

### Claim 8 (depends on 7)

The method of claim 7, further comprising sealably coupling the hemostasis valve to the valved medical device.

### Claim 9 (depends on 8)

The method of claim 8, further comprising disposing a second guidewire through the second sealable opening when the first guidewire is disposed through the first sealable opening or disposing the second guidewire through the first sealable opening when the first guidewire is disposed through the second sealable opening.

### Claim 10 (depends on 9)

The method of claim 9, further comprising disposing the second guidewire through each of the hemostasis valve and the valved medical device.

### Claim 11

A hemostasis valve system comprising:
a hemostasis valve including:
a body;
a valve member coupled to the body, the valve member including:
a first sealable opening disposed through a first portion of the valve member; and
a second sealable opening disposed through a second portion of the valve member; and
a hemostasis valve lumen extending between a proximal end portion and a distal end portion of the hemostasis valve; and
an insertion device including:
an elongate member; and
a lumen extending from a distal end of the elongate member and through a portion of the elongate member, wherein the insertion device is configured to be disposed through the first and second sealable openings of the hemostasis valve.

### Claim 12 (depends on 11)

The hemostasis valve system of claim 11, further comprising a coupling member disposed adjacent the distal end portion of the hemostasis valve, wherein the coupling member is configured to couple the hemostasis valve to a valved medical device.

### Claim 13 (depends on 12)

The hemostasis valve system of claim 12, further comprising a valve bypass portion extending distally from the distal end portion of the hemostasis valve, wherein the hemostasis valve lumen extends through a portion of the valve bypass portion.

### Claim 14 (depends on 13)

The hemostasis valve system of claim 13, wherein the valve bypass portion is configured to bypass the valve of the valved medical device when the hemostasis valve is coupled to the valved medical device such that the hemostasis valve is in fluid communication with the valved medical device.

### Claim 15 (depends on 11)

The hemostasis valve system of claim 11, wherein the valve member further comprises a third sealable opening disposed through a third portion of the valve member, and wherein the insertion device is configured to be disposed through the third sealable opening.

### Claim 16 (depends on 11)

The hemostasis valve system of claim 11, wherein the insertion device further comprises a side opening disposed through a sidewall of the insertion device.

### Claim 17 (depends on 16)

The hemostasis valve system of claim 16, wherein the insertion device further comprises a handle disposed proximal of the side opening.

### Claim 18 (depends on 11)

The hemostasis valve system of claim 11, wherein a distal end portion of the insertion device is tapered.

### Claim 19 (depends on 11)

The hemostasis valve system of claim 11, wherein a distal end portion of the insertion device is not tapered.

### Claim 20 (depends on 11)

The hemostasis valve system of claim 11, wherein the insertion device further comprises a slit extending between the distal opening and the side opening, and wherein the slit extends through the sidewall of the insertion device between the lumen and an exterior of the insertion device.