# US 12,178,436 B2 · Method to stop bleeding, with short hemostasis duration using a low dose of anticoagulant

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- Number: US 12,178,436 B2
- Document ID: US12178436B2
- Status: Granted
- Kind: B2
- Application number: 17/736,213
- Filed: 2022-05-04
- Published: 2022-08-18
- Granted: 2024-12-31
- Earliest claimed: 2013-07-12
- Assignees: Vasoinnovations, Inc.
- Applicants: Samir Bipin Pancholy
- Inventors: Samir Bipin Pancholy
- Web page: https://patentgrep.com/patent/US12178436B2

## CPC

- A61B 17/12: for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B 17/12009: {Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot}
- A61B 17/1325: {with means for applying local pressure (pressure pads A61F5/30)}
- A61B 17/135: inflatable
- A61B 2017/12004: {for haemostasis, for prevention of bleeding}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Disclosed are methods and devices for obtaining patent hemostasis of the radial artery by compressing the uninstrumented ulnar artery to increase radial artery flow. The device comprises a band having an inflatable bladder for applying blunt pressure to the ulnar artery. The method comprises applying a pressure to the homolateral ulnar artery and applying a pressure to the radial artery at the access site to obtain hemostasis at the access site. The method further comprises administering an anticoagulant to a patient at a dose ranging from about 20 units per kg of body weight to about 30 units per kg of body weight.

## Claims

### Claim 1

A method of obtaining patent hemostasis of a radial artery of a patient when performing a catheterization procedure at an access site of the radial artery, comprising performing the following steps:
(a) administering a dose of anticoagulant to the patient during the catheterization procedure, wherein the dose of anticoagulant is less than an equivalent of 50 units of unfractionated heparin per kg of body weight;
(b) applying a compressive pressure to the radial artery at the access site for a duration of time, wherein the duration of time is about 60 minutes;
(c) attaining patent hemostasis of the radial artery;
wherein step (a) precedes all other steps, the compressive pressure to the radial artery in step (b) is gradually reduced after about 60 minutes of compression of the radial artery at the access site.

### Claim 2 (depends on 1)

The method of claim 1, further comprising a step of monitoring and/or confirming patency of the radial artery, the step of monitoring and/or confirming patency of the radial artery being performed by sensing skin blood flow and/or pulsation at a finger-tip or other location downstream of the access site.

### Claim 3 (depends on 2)

The method of claim 2, wherein the step of confirming patency includes the use of digital plethysmography.

### Claim 4 (depends on 1)

The method of claim 1, wherein performing the catheterization procedure comprises using a sheath to access the radial artery.

### Claim 5 (depends on 4)

The method of claim 4, further comprising applying an ulnar pressure to an ipsilateral ulnar artery while the sheath remains inserted in the radial artery.

### Claim 6 (depends on 1)

The method of claim 1, wherein step (a) comprises administering anticoagulant at any time after introduction of a catheter or an introducer sheath and before removal of the catheter or the introducer sheath.

### Claim 7 (depends on 1)

The method of claim 1, wherein step (a) comprises administering anticoagulant at any time before introduction of a catheter and/or an introducer sheath.

### Claim 8 (depends on 1)

The method of claim 1, where the anticoagulant is selected from a group consisting of: heparin, dalteparin, danaparoid, enoxaparin, unfractionated heparin, low molecular weight heparin, direct thrombin inhibitors including hirudin, argatroban, bivalirudin, and combinations or derivatives thereof.

### Claim 9 (depends on 1)

The method of claim 1, wherein the dose of anticoagulant in step (a) is less than an equivalent of 25 units of unfractionated heparin per kg of body weight.

### Claim 10 (depends on 1)

The method of claim 1, wherein the compressive pressure to the radial artery is applied using a first band comprising at least a first inflatable bladder, the first inflatable bladder applying a compressive pressure to the radial artery at the access site.

### Claim 11 (depends on 10)

The method of claim 10, further comprising applying a compressive pressure to an ipsilateral ulnar artery using at least a second inflatable bladder, the first band comprising the second inflatable bladder.

### Claim 12 (depends on 1)

The method of claim 1, further comprising applying an ulnar pressure to an ipsilateral ulnar artery at an ulnar pressure site.

### Claim 13 (depends on 12)

The method of claim 12, wherein the ulnar pressure site is a Guyon's canal.

### Claim 14 (depends on 12)

The method of claim 12, wherein applying the ulnar pressure to the ipsilateral ulnar artery comprises: providing a band having an inflatable bladder, securing the band over a wrist such that the bladder contacts the ulnar pressure site, and inflating the bladder to compress the ipsilateral ulnar artery at the ulnar pressure site.

### Claim 15 (depends on 10)

The method of claim 10, wherein the ulnar pressure is applied using a technique selected from a group consisting of (i) a second band comprising at least a second inflatable bladder, wherein the second bladder applies the ulnar pressure, (ii) a mechanical device applies a compressing force at the ulnar pressure site; (iii) manual pressure is applied at the ulnar pressure site.

### Claim 16 (depends on 10)

The method of claim 10, wherein applying the ulnar pressure to the ulnar artery compresses the ulnar artery partially or fully.

### Claim 17 (depends on 10)

The method of claim 10, wherein the ulnar pressure is applied intermittently.

### Claim 18 (depends on 10)

The method of claim 10, wherein the ulnar pressure is applied continuously.

### Claim 19

A method of obtaining patent hemostasis of a radial artery of a patient when performing a catheterization procedure at an access site of the radial artery, comprising performing the following steps:
(a) administering a dose of anticoagulant to the patient during the catheterization procedure, wherein the dose of anticoagulant is less than an equivalent of 50 units of unfractionated heparin per kg of body weight;
(b) applying a compressive pressure to the radial artery at the access site for a duration of time, wherein the duration of time is about 60 minutes;
(c) monitoring and/or confirming patency of the radial artery, the step of monitoring and/or confirming patency of the radial artery being performed by sensing skin blood flow and/or pulsation at a finger-tip or other location downstream of the access site;
(d) attaining patent hemostasis of the radial artery;
wherein step (a) precedes all other steps, the compressive pressure to the radial artery in step (b) is reduced after about 60 minutes of compression of the radial artery at the access site;
wherein step (a) comprises administering anticoagulant at any time after introduction of a catheter or an introducer sheath and before removal of the catheter or the introducer sheath; and
wherein the compressive pressure to the radial artery is applied using a first band comprising at least a first inflatable bladder, the first inflatable bladder applying a compressive pressure to the radial artery at the access site.

### Claim 20

A method of obtaining patent hemostasis of a radial artery of a patient when performing a catheterization procedure at an access site of the radial artery, comprising performing the following steps:
(e) administering a dose of anticoagulant to the patient during the catheterization procedure, wherein the dose of anticoagulant is less than an equivalent of 50 units of unfractionated heparin per kg of body weight;
(f) applying a compressive pressure to the radial artery at the access site for a duration of time, wherein the duration of time is about 60 minutes;
(g) monitoring and/or confirming patency of the radial artery, the step of monitoring and/or confirming patency of the radial artery being performed by sensing skin blood flow and/or pulsation at a finger-tip or other location downstream of the access site;
(h) attaining patent hemostasis of the radial artery;
wherein step (a) precedes all other steps, the compressive pressure to the radial artery in step (b) is reduced after about 60 minutes of compression of the radial artery at the access site;
wherein step (a) comprises wherein step (a) comprises administering anticoagulant at any time before introduction of a catheter and/or an introducer sheath; and
wherein the compressive pressure to the radial artery is applied using a first band comprising at least a first inflatable bladder, the first inflatable bladder applying a compressive pressure to the radial artery at the access site.
