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EP-3937799-B1 - TISSUE COMPRESSION DEVICE

EP3937799B1EP 3937799 B1EP3937799 B1EP 3937799B1EP-3937799-B1

Inventors

  • CASTELLI, BRIAN

Dates

Publication Date
20260506
Application Date
20200312

Claims (6)

  1. A non-circumferential tissue compression device (100, 200, 300) comprising: a base (102, 202, 302) configured to, when on a wrist of a patient, surround at least a portion of the wrist in a non-circumferential configuration; and an expandable member (106, 206, 306) mechanically connected to the base (102, 202, 302), wherein the expandable member (106, 206, 306) is configured to be positioned over an ulnar region or a radial region of the wrist of the patient when the base (102, 202, 302) surrounds the portion of the wrist, and wherein the expandable member (106, 206, 306) is configured to apply pressure to the ulnar region or the radial region, wherein the base (102, 202, 302) comprises: a first section (110) extending from a terminal end (116, 316) to a medial end (118), wherein the first section (110) is configured to traverse one of a radial side of the wrist or an ulnar side of the wrist when the base (102, 202, 302) is on the wrist; a second section (112) extending from a terminal end (120, 320) to a medial end (122), wherein the second section (112) is configured to traverse the other of the radial side of the wrist or the ulnar side of the wrist when the base (102, 202, 302) is on the wrist; and a third section (114) extending between the medial end (118) of the first section (110) and the medial end (118) of the second section (112); characterized in that the expandable member (106, 206, 306) comprises a protrusion (207) extending from a surface of the expandable member (106, 206, 306) and configured to apply pressure to a tissue near an ulnar artery or a radial artery of the patient.
  2. The tissue compression device of claim 1, wherein, when on the wrist of the patient, the tissue compression device (100, 200, 300) is configured to partially surround the wrist in a first orientation and in a second, different orientation, and wherein, when in the first orientation, the expandable member (106, 206, 306) is positioned over the ulnar region, and wherein, when in the second orientation, the expandable member (106, 206, 306) is positioned over the radial region.
  3. The tissue compression device of any one of the preceding claims, wherein the expandable member (106, 206, 306) is a first expandable member (306A) configured to be positioned over the ulnar region of the wrist of the patient when the base (102, 202, 302) surrounds the portion of the wrist and apply pressure to the ulnar region, wherein the tissue compression device (100, 200, 300) further comprises a second expandable member (306B) mechanically connected to the base (102, 202, 302), wherein the second expandable member (306B) is configured to be positioned over the radial region of the wrist of the patient and apply pressure to the radial region when the base (102, 202, 302) surrounds the portion of the wrist.
  4. The tissue compression device of claim 3, wherein the first expandable member (306A) comprises a first bladder configured to inflate to at least a pressure to cause compression of tissue near an ulnar artery of the patient, and wherein the second expandable member (306B) comprises a second bladder configured to inflate to at least a pressure to cause patent hemostasis of a vascular access site at the radial artery of the patient.
  5. The tissue compression device of claim 3, wherein the second expandable member (306B) comprises a bladder configured to inflate to at least a pressure to urge the wrist of the patient toward the first expandable member (306A).
  6. The tissue compression device of any one of the preceding claims, wherein the terminal end (116, 316) of the first section (110) and the terminal end (120, 320) of the second section (112) define a gap (124), wherein the gap is sized to enable the wrist of the patient to pass through the gap (124).

Description

TECHNICAL FIELD This disclosure relates to tissue compression devices. BACKGROUND A medical catheter may be advanced through an access site into vasculature of a patient to provide a lumen through which a medical device or a therapeutic agent may be introduced to reach a treatment site. For example, the access site for percutaneous coronary procedures may include the radial artery or the femoral artery of a patient. CN 201 551 360 U describes a radial artery extracorporeal compression apparatus. US 5,468,220 A relates to a carpal tunnel bracelet. EP 1 295 564 A1 describes an adjustable radial artery compressor. A further non-circumferential tissue compressing device is known from CN204379363U. SUMMARY The present disclosure describes tissue compression devices and techniques to apply pressure to an ulnar region (e.g., and not a radial region), a radial region (e.g., and not an ulnar region), or both the ulnar and radial regions of a patient before, during, and/or after a transradial access procedure. The ulnar region may include tissue at or near (e.g., superficial to) an ulnar artery and/or ulnar veins in an arm of the patient. The radial region may include tissue at or near (e.g., superficial to) a radial artery and/or radial veins in an arm of the patient. Application of pressure at the ulnar region may be used to facilitate transradial access, reduce occlusion of the radial artery after transradial procedure, or both. Application of pressure at the radial region may be used to facilitate transradial access, achieve patent hemostasis of the access site of the radial artery after transradial procedure, or both. According to the invention, which relates to a tissue compression device as defined in the independent claim 1, the tissue compression device is non-circumferential, which enables it to apply pressure to less than the entire outer perimeter of a wrist of a patient at a particular time. In this way, the tissue compression device may be configured to more selectively (e.g., more directly) apply pressure to only one of the ulnar region or the radial region at a time. The non-circumferential tissue compression device includes a base configured to, when on a wrist of a patient, surround at least a portion of the wrist in a non-circumferential configuration, and an expandable member coupled to the base. The non-circumferential configuration may include a "C" shape configured to allow a clinician to fit the tissue compression device onto the wrist of the patient, orient the tissue compression device to engage the wrist of the patient, and to enable the expandable member to be inflated without becoming disengaged with the wrist of the patient. The expandable member is configured to be positioned over an ulnar region or a radial region of the patient when the wrist is engaged. The expandable member also is configured to apply pressure to the ulnar region or radial region before, during, and/or after a transradial access procedure. According to the invention the device further comprises an expandable member mechanically connected to the base. The expandable member is configured to be positioned over an ulnar region or a radial region of the wrist of the patient when the base is engaged with the portion of the wrist. The expandable member also is configured to apply pressure to the ulnar region or the radial region. In some aspects of the tissue compression device, the expandable member comprises a bladder configured to inflate to at least a pressure to cause compression of tissue near at least one of an ulnar artery or a radial artery of the patient. In some aspects the tissue compression device, when on the wrist of the patient, the tissue compression device is configured to partially surround the wrist in a first orientation and in a second, different orientation, and, when in the first orientation, the expandable member is positioned over the ulnar region, and, when in the second orientation, the expandable member is positioned over the radial region. In some aspects the tissue compression device, when the base is on the wrist of the patient, the expandable member is configured to more directly apply pressure to the ulnar region than the radial region. In some aspects of the tissue compression device, when the base is on the wrist of the patient, the expandable member is configured to more directly apply pressure to the radial region than the ulnar region. In some aspects of the tissue compression device, the base comprises a first curved section extending from a terminal end to a medial end, wherein the first curved section is configured to traverse one of a radial side of the wrist or an ulnar side of the wrist when the base is on the wrist, a second curved section extending from a terminal end to a medial end, wherein the second curved section is configured to traverse the other of the radial side of the wrist or the ulnar side of the wrist when the base is on the wrist, and a substantially straight se