REMOTE ISCHEMIC PRECONDITIONING APPLICATION DEVICE AND METHOD

A remote ischemic preconditioning application device may include a first compression portion that is operable to apply a coil shaped pressure pattern around at least 360 degrees of an upper arm portion and a second compression portion that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of a lower arm portion. The device may use remote ischemic preconditioning to: reduce blood flow in the upper and lower arm portions for at least 30 continuous minutes; and 2) increase blood flow in the patient as a result of remote ischemic preconditioning.

I. BACKGROUND OF THE INVENTION

A. Field of Invention

This invention pertains to the art of methods and apparatuses regarding Remote Ischemic Preconditioning (RIPC).

B. Description of the Related Art

Remote ischemic preconditioning (RIPC) is a process via which short periods of sub-lethal ischemia administered to a distant organ or extremity prior to an ischemic cardiac insult results in decreased injury. The concept of RIPC has been well established in the scientific literature for over a quarter of century, though the translation of this finding to the bedside has largely been unsuccessful as the majority of trials have involved short bursts of sub-lethal ischemia via single pressure point compression in patients already suffering from ischemic heart disease (IHD).

II. SUMMARY OF THE INVENTION

According to some embodiments of this invention, a remote ischemic preconditioning application device may be used with an associated patient having an arm with an upper arm portion and a lower arm portion. The device may comprise: a first compression portion that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the upper arm portion; a second compression portion that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the lower arm portion; and a controller that operates the first and second compression portions using remote ischemic preconditioning to: 1) reduce blood flow in the upper and lower arm portions for at least 30 continuous minutes; and 2) increase blood flow in the patient as a result of remote ischemic preconditioning.

According to some embodiments of this invention, the remote ischemic preconditioning application device may include a first compression portion that is selectively operable to apply the coil shaped pressure pattern as a generally helically shaped pressure pattern around the upper arm portion for at least 360 degrees; and a second compression portion that is selectively operable to apply the coil shaped pressure pattern as a generally helically shaped pressure pattern around the lower arm portion for at least 1440 degrees.

According to some embodiments of this invention, the remote ischemic preconditioning application device may include a first compression portion that is selectively inflatable to apply the coil shaped pressure pattern around the upper arm portion; and a second compression portion that is selectively inflatable to apply the coil shaped pressure pattern around the lower arm portion.

According to some embodiments of this invention, the remote ischemic preconditioning application device may include a first compression portion that is selectively operable to apply the coil shaped pressure pattern around the upper arm portion using only sub-occlusive pressure; and a second compression portion that is selectively operable to apply the coil shaped pressure pattern around the lower arm portion using only sub-occlusive pressure.

According to some embodiments of this invention, the remote ischemic preconditioning application device may include a first compression portion as a bicep cuff; and a controller that is operable using the bicep cuff and a pressure sensor to determine systolic and diastolic blood pressure of the associated patient's arm.

According to some embodiments of this invention, the remote ischemic preconditioning application device may include a controller that operates the first and second compression portions using remote ischemic preconditioning to reduce blood flow in the upper and lower arm portions simultaneously.

According to some embodiments of this invention, the remote ischemic preconditioning application device may include a controller that operates the first and second compression portions using remote ischemic preconditioning to reduce blood flow in the upper and lower arm portions sequentially.

According to some embodiments of this invention, a method may be used in applying remote ischemic preconditioning to an associated patient having an arm with an upper arm portion and a lower arm portion. The method may comprise the steps of: A) providing a remote ischemic preconditioning application device comprising: 1) a first compression portion that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the upper arm portion; 2) a second compression portion that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the lower arm portion; and 3) a controller that operates the first and second compression portions; B) providing the remote ischemic preconditioning application device to be operable to perform the steps of: 1) reducing blood flow in the upper and lower arm portions for at least 30 continuous minutes; and 2) increasing blood flow in the patient as a result of remote ischemic preconditioning.

According to some embodiments of this invention, the method may include the step of: reducing blood flow in the upper and lower arm portions simultaneously.

According to some embodiments of this invention, the method may include the step of: reducing blood flow in the upper and lower arm portions sequentially.

According to some embodiments of this invention, the method may include the step of: reducing blood flow in the upper and lower arm portions using only sub-occlusive pressure.

According to some embodiments of this invention, the method may include the steps of: providing the first compression portion to be selectively inflatable to apply the coil shaped pressure pattern as a generally helically shaped pressure pattern around the upper arm portion; and providing the second compression portion to be selectively inflatable to apply the coil shaped pressure pattern as a generally helically shaped pressure pattern around the lower arm portion.

According to some embodiments of this invention, the method may include the steps of: providing the first compression portion to be a bicep cuff; providing a pressure sensor; and providing the controller to be operable using the bicep cuff and the pressure sensor to determine systolic and diastolic blood pressure of the associated patient's arm.

According to some embodiments of this invention, the method may include a controller that is operable to: calculate the mean arterial pressure from the blood pressure; re-inflate the bicep cuff to achieve and maintain the mean arterial pressure; and deflate the bicep cuff after 30 continuous minutes.

According to some embodiments of this invention, a remote ischemic preconditioning application device may be used with an associated patient having an arm with an upper arm portion and a lower arm portion. The device may comprise: a bicep cuff that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the upper arm portion; a forearm strap that extends from the bicep cuff and that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the lower arm portion; and a controller that operates the bicep cuff and the forearm strap using remote ischemic preconditioning to: 1) reduce blood flow in the upper and lower arm portions using only sub-occlusive pressure; and 2) increase blood flow in the patient as a result of remote ischemic preconditioning.

According to some embodiments of this invention, a remote ischemic preconditioning application device may include a bicep cuff that is selectively operable to apply the coil shaped pressure pattern as a generally helically shaped pressure pattern around at least 720 degrees of the upper arm portion; and a forearm strap that is selectively operable to apply the coil shaped pressure pattern as a generally helically shaped pressure pattern around at least 1440 degrees of the lower arm portion.

According to some embodiments of this invention, a remote ischemic preconditioning application device may include a bicep cuff that is selectively inflatable to apply the generally helically shaped pressure pattern around the upper arm portion; and a forearm strap that is selectively inflatable to apply the generally helically shaped pressure pattern around the lower arm portion.

According to some embodiments of this invention, a remote ischemic preconditioning application device may include a bicep cuff that comprises an arm contact surface that is selectively operable to apply the generally helically shaped pressure pattern around the upper arm portion; and a forearm strap that comprises an arm contact surface that is selectively operable to apply the generally helically shaped pressure pattern around the lower arm portion. The arm contact surface of the bicep cuff may have a width of 1.0 inches or less; and the arm contact surface of the forearm strap may have a width of 1.0 inches or less.

According to some embodiments of this invention, a remote ischemic preconditioning application device may include a controller that is operable using the bicep cuff and a pressure sensor to determine systolic and diastolic blood pressure of the associated patient's arm.

According to some embodiments of this invention, a remote ischemic preconditioning application device may include a controller that operates the bicep cuff and the forearm strap using remote ischemic preconditioning to reduce blood flow in the upper and lower arm portions for at least 30 continuous minutes.

IV. DETAILED DESCRIPTION

Referring now to the drawings wherein the showings are for purposes of illustrating embodiments of the invention only and not for purposes of limiting the same,FIG. 1illustrates a patient100, including limbs in the form of arms102,102, and legs104,104, each having upper and lower portions106,108, and110,112, respectively. While a later to be described remote ischemic preconditioning application device will be described as being applied to one of the patient's arms102, it should be understood that in other embodiments it may be applied to one of the patient's legs104. It should also be understood that while the remote ischemic preconditioning application device will be described as being applied to a single limb, in other embodiments in may be applied to two or more limbs in any combination chosen with the sound judgment of a person of skill in the art. Because both the upper and lower portions of the limb are used in the embodiments described, the remote ischemic preconditioning application device may be considered a “full limb” device. This does not mean that the device must contact every part of a patient's limb, it means that the device contacts and applies a compression force to at least part of the upper limb portion and part of the lower limb portion.

The present inventor was surprised to discover, but then established, that relatively longer, consistent, and full limb compression for at least 30 minutes in patients at risk, but not suffering from ischemic heart disease (IHD), results in beneficial remote ischemic preconditioning (RIPC) stimulus. Specifically, subjects with this type of RIPC stimulus experienced increased blood flow in the contralateral arm as measured via peak systolic velocity via ultrasound as shown inFIG. 2as well as decreased monocyte adhesion in vitro as shown inFIG. 3. An almost two fold increase in change in brachial artery diameter in the contralateral arm acutely after a single use was detected as shown inFIG. 4.

The present inventor also discovered that numerous embodiments of remote ischemic preconditioning application devices (RIPCDs) can be used to achieve the desired beneficial RIPC results. In each case, the RIPCD includes a first compression portion that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the upper limb portion and a second compression portion that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the lower limb portion. By “coil shaped” it meant any looping pattern generally in the shape of a coil. In some non-limiting embodiments, the coil shaped pressure pattern is helical in shape.

FIGS. 5, 6A and 6Bshow one embodiment RIPCD500having a first compression portion502that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the upper arm portion (the bicep portion) and a second compression portion504that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the lower arm portion (the forearm portion), as shown. For the embodiment shown, the first and second compression portions502,504are each formed of straps508,510, respectively, that wrap around the patient's arm. The RIPCD500may, in some embodiments, also include a webbing portion514that interconnects the straps506,508. Such interconnection makes the RIPCD500a unitary device, easy to store and apply by an operator. In a more specific embodiment, the second compression portion504may be selectively operable to apply a coil shaped pressure pattern around at least 1440 degrees of the lower arm portion (at least four full loops). In yet another embodiment, shown, the second compression portion504is selectively operable to apply a coil shaped pressure pattern around at least 2160 degrees of the lower arm portion (at least six full loops). In yet another embodiment, one or both of the compression portions502,504may be generally helically shaped.

With continuing reference toFIGS. 5, 6A and 6B, the RIPCD may also have a controller506that operates the compression portions502,504using remote ischemic preconditioning in order to: 1) reduce the blood flow in the upper and lower arm portions for at least 30 continuous minutes; and 2) increase blood flow in the patient as a result of remote ischemic preconditioning. The controller506may be of any type chosen with the sound judgment of a person of skill in the art and may include and/or work with one or more pressure sensors positioned to determine the required pressure(s). In some embodiments a pressure sensor measures the patient's blood pressure (such as systolic and diastolic) in the patient's arm. In other embodiments, a pressure sensor measures inflation pressure created by the RIPCD. The controller506may be used to increase the tightness of the compression portions502,504on the patient's arm. In one embodiment, the controller506includes a microprocessor that is programmed to perform the algorithms necessary to achieve the pressures in the limb described.

In some embodiments, the controller506may be used to apply the pressure in one or both of the compression portions502,504using only sub-occlusive pressure. In some embodiments, the controller508may be used to reduce blood flow in the upper and lower arm portions502,504simultaneously. In another embodiment, the controller508may be used to reduce blood flow in the upper and lower arm portions502,504sequentially. The controller508may, for example, reduce blood from in the upper arm portion502before (or after) it reduces blood from in the lower arm portion504. In some embodiments where inflation pressure is used, the controller is operable to: calculate the mean arterial pressure from the blood pressure; re-inflate the bicep cuff to achieve and maintain the mean arterial pressure; and deflate the bicep cuff after 30 continuous minutes

FIGS. 7-13, illustrate RIPCDs600,700,800,900,1000,1100,1200and1300that operate similarly to RIPCD500in that they include a first compression portion that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the upper arm portion (the bicep portion), a second compression portion that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the lower arm portion (the forearm portion) and a controller that operates the compression portions using remote ischemic preconditioning in order to: 1) reduce the blood flow in the upper and lower arm portions for at least 30 continuous minutes; and 2) increase blood flow in the patient as a result of remote ischemic preconditioning. RIPCD700, seeFIG. 7, includes controller702and multiple straps704that can be manually inserted through corresponding openings706, as shown, to initially attached the RIPCD700to the patient's arm. RIPCDs800and900, seeFIGS. 8-9, each include a controller802,902and multiple straps804,904that are interconnected with webbing portions806,906respectively, but the specific pattern varies, as shown. RIPCDs1000and1100, seeFIGS. 10-11, include straps1002,1102that can be held together with fasteners1004,1104. The fasteners1004may be hook and loop fasteners that selectively attach to the straps1002. Fasteners1104may use tabs received in holes1106formed in the straps1102. RIPCD1200, seeFIG. 12, includes multiple straps1202that can be manually wrapped together using hook and loop fasteners1204. RIPCD1300, seeFIG. 13, includes a controller1302and multiple straps1304interconnected with webbing portion1306. Latch portions1308may also be used to interconnect the straps1304. In another embodiment, the straps used with RIPCDs700,800,900,1000,1100,1200and1300are not coiled but rather form generally circular shaped pressure patterns on the patient's arm.

FIGS. 14A and 14B, illustrate RIPCD1400which includes a first compression portion,1402in the form of a bicep cuff, that is selectively operable to apply a coil shaped pressure pattern around at least 360 degrees of the upper arm portion (the bicep portion), a second compression portion1402, in the form of a strap, that is selectively wrappable about the arm to apply a coil shaped pressure pattern around at least 360 degrees of the lower arm portion (the forearm portion) and a controller1406that operates the compression portions using remote ischemic preconditioning in order to: 1) reduce the blood flow in the upper and lower arm portions for at least 30 continuous minutes; and 2) increase blood flow in the patient as a result of remote ischemic preconditioning. In one embodiment, both compression portions1402,1404selectively apply (and remove) pressure using pneumatic inflation.

FIGS. 15-18, illustrate RIPCDs1500,1600,1700and1800that include a first compression portion that is selectively operable to apply a circular or coil shaped pressure pattern around at least 360 degrees of the upper arm portion (the bicep portion) and a second compression portion that is selectively operable to apply a circular or coil shaped pressure pattern around at least 360 degrees of the lower arm portion (the forearm portion). These devices, however, use only manual devices to apply the required pressure to use remote ischemic preconditioning in order to: 1) reduce the blood flow in the upper and lower arm portions for at least 30 continuous minutes; and 2) increase blood flow in the patient as a result of remote ischemic preconditioning. RIPCD1500, seeFIG. 15, uses straps1502that may use elastic or non-elastic materials that can be applied using hook and loop fastening techniques and/or buckles1504. The straps1502may be interconnected with a sleeve1506, as shown. RIPCD1600, seeFIG. 16, includes a sleeve1602and uses pull band straps1602to create the necessary pressure. RIPCD1700, seeFIG. 17, includes a sleeve1702and uses one upper and one lower strap1704that are tightened using laces1706, similar to shoelaces. RIPCD1800, seeFIG. 18, includes a sleeve1802and uses a BOA® system1804to create the necessary pressure.

In many embodiments described above, one or more straps are used. The straps may have arm contact surfaces that apply the pressure pattern to the patient's arm. In some embodiments, the arm contact surface of the strap has a width of 1.0 inch or less. In another embodiment, the arm contact surface of the strap has a width of 0.75 inches or less. In another embodiment, the arm contact surface of the strap has a width of 0.5 inches or less.

In the patent claims that follow, it should be understood that any component referred to as being “associated” is not being claimed positively but rather indicates the environment in which the claimed invention is used. Thus, for one non-limiting example, if a patent claim includes “an associated patient” then Applicant's intent is that infringement does not require an actual patient or patient's limb. Rather, infringement only requires the device or method can be used with a patient.

Having thus described the invention, it is now claimed: