# US 9,039,667 B1 · Hemostatic device and method

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- Number: US 9,039,667 B1
- Document ID: US9039667B1
- Status: Granted
- Kind: B1
- Application number: 14/606,324
- Filed: 2015-01-27
- Published: 2015-05-28
- Granted: 2015-05-26
- Earliest claimed: 2013-03-19
- Assignees: Biolife, L.L.C.
- Applicants: Biolife, L.L.C.
- Inventors: John Hen; Talmadge Kelly Keene; Mark Travi
- Web page: https://patentgrep.com/patent/US9039667B1

## CPC

- A61B 17/12159: {Solid plugs; being solid before insertion}
- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61B 17/12163: {having a string of elements connected to each other}
- A61L 15/18: containing inorganic materials
- A61L 24/0015: {Medicaments; Biocides}
- A61L 24/02: containing inorganic materials
- A61L 24/06: obtained by reactions only involving carbon-to-carbon unsaturated bonds {(A61L24/043, A61L24/046 take precedence)}
- A61M 25/02: Holding devices, e.g. on the body
- A61M 35/00: Devices for applying media, e.g. remedies, on the human body (devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15)
- A61M 35/003: {Portable hand-held applicators having means for dispensing or spreading integral media (hand-held massage devices with liquid delivery A61H7/003)}
- A61M 35/006: {using sponges, foams, absorbent pads or swabs as spreading means}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/12004: {for haemostasis, for prevention of bleeding}
- A61B 2017/12054: {Details concerning the detachment of the occluding device from the introduction device}
- A61F 13/00: Bandages or dressings (radioactive dressings {A61N5/1029}); Absorbent pads
- A61F 13/36: Surgical swabs, e.g. for absorbency or packing body cavities during surgery (A61F13/38, A61M35/006 take precedence)
- A61F 2013/00412: {for use with needles, tubes or catheters}
- A61F 2013/00472: {with chemical means}
- A61L 15/60: Liquid-swellable gel-forming materials, e.g. super-absorbents
- A61L 2300/102: Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
- A61L 2300/418: Agents promoting blood coagulation, blood-clotting agents, embolising agents
- A61L 2400/04: Materials for stopping bleeding
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A method of arresting blood flow from a bleeding wound including the steps of (1) providing a solid hemostatic tablet preferably including potassium ferrate and a cation ion exchange resin pressure formed into a tablet for delivery onto a bleeding wound, the tablet defining a proximal portion and a distal portion, (2) applying the proximal portion against the bleeding wound to improve the rate of adhesion to a bleeding wound surface, and then (3) applying pressure against the tablet over the wound site. After the seal is formed from the interaction of blood or exudates with the proximal portion of the tablet, the distal portion of the tablet delaminates from the proximal portion to form a reservoir to stop further bleeding and to provide antimicrobial protection and healing. The tablet may be applied to any surface orientation and take any shape and thickness possible.

## Claims

### Claim 1

A method of arresting the flow of blood from a bleeding wound comprising the steps of:
providing a hemostatic tablet prepared from a powderous mixture which will hydrate in the presence of blood thereby promoting clotting of the blood;
said hemostatic tablet defining a proximal portion and a distal portion;
applying said proximal portion directly to the bleeding wound while a pressure is applied to said distal portion;
said proximal portion promoting blood clotting at the bleeding wound forming a protective seal over the wound for sealing the bleeding wound;
said distal portion delaminating from said proximal portion to constitute a reservoir for persistent and long lasting protection against further bleeding and exudation.

### Claim 2

A method of arresting the flow of blood from a bleeding wound comprising the steps of:
providing a solid hemostatic tablet defining a proximal portion and a distal portion;
said hemostatic tablet formed from an insoluble cation exchange material and a salt ferrate;
applying said proximal portion directly to the bleeding wound in any orientation of the bleeding wound while applying a pressure to said distal portion of said hemostatic tablet;
promoting blood clotting at the wound with said salt ferrate of said proximal portion;
forming a protective scab over the wound for sealing the bleeding wound with said cation exchange material of said proximal portion; and
said insoluble cation exchange material and said salt ferrate of said distal portion delaminating from said proximal portion constituting a reservoir for persistent and long lasting protection against further bleeding and exudation.

### Claim 3

A hemostatic device adapted to be applied directly to a bleeding wound, comprising: a solid hemostatic tablet defining a proximal portion and a distal portion; a support attached to said tablet to facilitate positioning and holding said tablet against the wound; said proximal portion applied directly to the bleeding wound while a pressure is applied to said distal portion; said proximal portion promoting blood clotting at the bleeding wound forming a protective seal over the wound for sealing the bleeding wound; said distal portion delaminating from said proximal portion to constitute a reservoir for persistent and long lasting protection against further bleeding and exudation.

### Claim 4 (depends on 3)

A hemostatic device as set forth in claim 3 wherein: said support is an elongated flexible adhesive carrier having an adhesive surface to which said tablet is attached, said adhesive surface attachable against skin to hold said skin contact surface against the wound.

### Claim 5 (depends on 4)

A hemostatic device as set forth in claim 4 wherein: said support is a line having a plurality of closely spaced small said tablets arranged along the length of said line, said line with said tablets capable of being aligned and held by said carrier atop an elongated open or sutured wound.

### Claim 6 (depends on 3)

A hemostatic device as set forth in claim 3, wherein: said support is an elongated rigid, semi-rigid or flexible handle attached to said tablet, said tablet being in a regular or irregular three-dimensional form having a uniform or varying cross section.

### Claim 7 (depends on 1)

A hemostatic device as set forth in claim 1, wherein: said support includes reinforcing fibers added to, and uniformly blended with, said mixture prior to tablet formation.

### Claim 8 (depends on 3)

A hemostatic device as set forth in claim 3, wherein: said support is a three-dimensional pliable, inert carrier having an outer surface onto which a plurality of small said tablets is attached.

### Claim 9

A hemostatic device adapted to be applied directly to a bleeding wound, comprising: a solid hemostatic tablet defining a proximal portion and a distal portion; a support attached to said tablet to facilitate positioning and holding said tablet against the wound; said hemostatic tablet being formed from an insoluble cation exchange material and a salt ferrate; said proximal portion applied directly to the bleeding wound in any orientation of the bleeding wound when a pressure is applied to said distal portion of said hemostatic tablet; said proximal portion forming a protective scab over the wound for sealing the bleeding wound; and said distal portion delaminating from said proximal portion constituting a reservoir for persistent and long lasting protection against further bleeding and exudation.

### Claim 10 (depends on 9)

A hemostatic device as set forth in claim 9 wherein: said support is an elongated flexible adhesive carrier having an adhesive surface to which said tablet is attached, said adhesive surface attachable against skin to hold said skin contact surface against the wound.

### Claim 11 (depends on 10)

A hemostatic device as set forth in claim 10 wherein: said support is a line having a plurality of closely spaced small said tablets arranged along the length of said line, said line with said tablets capable of being aligned and held by said carrier atop an elongated open or sutured wound.

### Claim 12 (depends on 9)

A hemostatic device as set forth in claim 9, wherein: said support is an elongated rigid, semi-rigid or flexible handle attached to said tablet, said tablet being in a regular or irregular three-dimensional form having a uniform or varying cross section.

### Claim 13 (depends on 9)

A hemostatic device as set forth in claim 9, wherein: said support is reinforcing fibers added to, and uniformly blended with, said mixture prior to tablet formation.

### Claim 14 (depends on 9)

A hemostatic device as set forth in claim 9, wherein: said support is a three-dimensional pliable, inert carrier having an outer surface onto which a plurality of small said tablets is attached.

### Claim 15

A hemostatic device for inhibiting bleeding from a catheter wound caused by the presence of the catheter in the wound, comprising: a solid hemostatic tablet defining a proximal portion and a distal portion; a support attached to said tablet to facilitate positioning and holding said tablet against the wound; said hemostatic tablet formed from an insoluble cation exchange material and a salt ferrate; said tablet having two separate half sections which fit together along mating edges to define a catheter access hole for receiving the catheter therethrough; said proximal portion promoting blood clotting at the catheter wound to form a protective scab over the catheter wound for sealing the bleeding of the catheter wound; said distal portion disassociating from said proximal portion constituting a reservoir for persistent and long lasting protection against further bleeding and exudation of the catheter wound.

### Claim 16 (depends on 15)

A hemostatic device as set forth in claim 15 wherein: said support is an elongated flexible adhesive carrier having an adhesive surface to which said tablet is attached, said adhesive surface attachable against skin to hold said skin contact surface against the wound.

### Claim 17 (depends on 16)

A hemostatic device as set forth in claim 16 wherein: said support is a line having a plurality of closely spaced small said tablets arranged along the length of said line, said line with said tablets capable of being aligned and held by said carrier atop an elongated open or sutured wound.

### Claim 18 (depends on 15)

A hemostatic device as set forth in claim 15, wherein: said support is an elongated rigid, semi-rigid or flexible handle attached to said tablet, said tablet being in a regular or irregular three-dimensional form having a uniform or varying cross section.

### Claim 19 (depends on 15)

A hemostatic device as set forth in claim 15, wherein: said support is reinforcing fibers added to, and uniformly blended with, said mixture prior to tablet formation.

### Claim 20 (depends on 15)

A hemostatic device as set forth in claim 15, wherein: said support is a three-dimensional pliable, inert carrier having an outer surface onto which a plurality of small said tablets is attached.
